Guest guest Posted October 10, 2005 Report Share Posted October 10, 2005 I wonder if this will work if melatonin does the opposite to you, like makes you wired? That's what it does to me. Lynda At 08:39 PM 10/10/2005, you wrote: >Hey ladies, >I thought I would share something I found out today. I know many of us >have sleep >disturbances. I just got back from my doctor and explained the problems I >was having >with sleep. I told him I did not want to take ambien because it is >habituating and does not >seem to work well for me anyway. My sleep schedule is so screwed up since >I got sick, >that I know I do not get enough sleep, and usually can't get to sleep >until 3 AM or later. >This medication works on the 'melatonin' receptors, and is not addictive, >according to the >doc -- indeed, it seems to be the only sleep medication that is not >addictive (except for >antidepressant like Doxepin which gives me headaches). >I am going to try it for one week. > >He has prescribed this: >The U.S. Food and Drug Administration (FDA) has approved the New Drug >Application >(NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia >characterized >by difficulty with sleep onset. > >The FDA approval allows physicians to prescribe Rozerem for long-term use >in adults. > >Rozerem is the first and only prescription sleep medication that has shown >no evidence of >abuse and dependence and, as a result, has not been designated as a >controlled substance >by the U.S. Drug Enforcement Administration (DEA). With the exception of >Rozerem, all >other prescription medications indicated for insomnia are classified as >Schedule IV >controlled substances by the DEA. Additionally, Rozerem is the first >prescription insomnia >medication with a new therapeutic mechanism of action in 35 years, and >will be available >for patients by late September. > >Rozerem has a unique therapeutic mechanism of action that selectively >targets two >receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is >known as the >body's " master clock " because it regulates 24-hour, or circadian, rhythms >including the >sleep-wake cycle. > >The Rozerem NDA, submitted in September 2004 by Takeda Global Research & >Development Center, Inc., was based on data collected from an extensive >clinical research >program, including recently completed clinical studies with more than >4,200 patients ages >18 to 93. In one study, 472 patients received single daily doses of >Rozerem for up to one >year. Also, based on recently presented clinical trials, Rozerem has been >shown to be safe >for older adults, as well as those who have mild-to-moderate chronic >obstructive >pulmonary disease (COPD) and mild-to-moderate sleep apnea. > >About Insomnia > >Approximately 60 million people in the United States suffer from insomnia, >yet the vast >majority remains undiagnosed and untreated. Insomnia is characterized by >difficulty >falling asleep, difficulty staying asleep, or poor quality sleep, leading >to impairment of >next-day functioning. > >Insomnia has been linked to a variety of health problems, including >obesity, diabetes, >hypertension, heart disease and depression. According to the U.S. Surgeon >General, nearly >$15 billion annually is spent on healthcare related to insomnia, while $50 >billion is lost in >productivity. > >About Rozerem > >Rozerem is indicated for the treatment of insomnia characterized by >difficulty with sleep >onset. Rozerem should not be used in patients with hypersensitivity to >ramelteon or any >components of the formulation. Rozerem can be prescribed for long-term >use. However, >failure of insomnia to remit after a reasonable period of time, worsening >of insomnia, or >the emergence of new cognitive or behavioral abnormalities after taking >Rozerem should >be evaluated, as such symptoms may be the result of an unrecognized >underlying medical >disorder. In primarily depressed patients, worsening of depression, >including suicidal >ideation, has been reported in association with the use of hypnotics. > >Rozerem should not be used by patients with severe hepatic impairment, or >in patients in >combination with fluvoxamine. > >Rozerem has not been studied in subjects with severe sleep apnea or severe >COPD and is >not recommended for use in those populations. Patients should be advised >to exercise >caution if they consume alcohol in combination with Rozerem. > >Rozerem has been associated with decreased testosterone levels and >increased prolactin >levels. As a result, healthcare professionals should be mindful of any >unexplained >symptoms possibly associated with such changes in these hormone levels. >Rozerem has >not been studied in children or adolescents, and the effects in these >populations are >unknown. > >Rozerem should be taken within 30 minutes before going to bed and >activities should be >confined to those necessary to prepare for bed. Rozerem should not be >taken with or >immediately after a high-fat meal. Engaging in hazardous activities that >require >concentration (such as operating a motor vehicle or heavy machinery) after >taking >Rozerem should be avoided. > >The most common adverse events seen with Rozerem that had greater than 2% >incidence >difference from placebo were somnolence, dizziness, and fatigue. > >For more information, please visit the Rozerem website. > > > > > >Opinions expressed are NOT meant to take the place of advice given by >licensed health care professionals. Consult your physician or licensed >health care professional before commencing any medical treatment. > > " Do not let either the medical authorities or the politicians mislead you. >Find out what the facts are, and make your own decisions about how to live >a happy life and how to work for a better world. " - Linus ing, >two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace) > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 10, 2005 Report Share Posted October 10, 2005 Wow, Lynda. I have no idea. Melatonin never did anything for me. The doc said this would, so all I can do is give it a try! > >Hey ladies, > >I thought I would share something I found out today. I know many of us > >have sleep > >disturbances. I just got back from my doctor and explained the problems I > >was having > >with sleep. I told him I did not want to take ambien because it is > >habituating and does not > >seem to work well for me anyway. My sleep schedule is so screwed up since > >I got sick, > >that I know I do not get enough sleep, and usually can't get to sleep > >until 3 AM or later. > >This medication works on the 'melatonin' receptors, and is not addictive, > >according to the > >doc -- indeed, it seems to be the only sleep medication that is not > >addictive (except for > >antidepressant like Doxepin which gives me headaches). > >I am going to try it for one week. > > > >He has prescribed this: > >The U.S. Food and Drug Administration (FDA) has approved the New Drug > >Application > >(NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia > >characterized > >by difficulty with sleep onset. > > > >The FDA approval allows physicians to prescribe Rozerem for long-term use > >in adults. > > > >Rozerem is the first and only prescription sleep medication that has shown > >no evidence of > >abuse and dependence and, as a result, has not been designated as a > >controlled substance > >by the U.S. Drug Enforcement Administration (DEA). With the exception of > >Rozerem, all > >other prescription medications indicated for insomnia are classified as > >Schedule IV > >controlled substances by the DEA. Additionally, Rozerem is the first > >prescription insomnia > >medication with a new therapeutic mechanism of action in 35 years, and > >will be available > >for patients by late September. > > > >Rozerem has a unique therapeutic mechanism of action that selectively > >targets two > >receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is > >known as the > >body's " master clock " because it regulates 24-hour, or circadian, rhythms > >including the > >sleep-wake cycle. > > > >The Rozerem NDA, submitted in September 2004 by Takeda Global Research & > >Development Center, Inc., was based on data collected from an extensive > >clinical research > >program, including recently completed clinical studies with more than > >4,200 patients ages > >18 to 93. In one study, 472 patients received single daily doses of > >Rozerem for up to one > >year. Also, based on recently presented clinical trials, Rozerem has been > >shown to be safe > >for older adults, as well as those who have mild-to-moderate chronic > >obstructive > >pulmonary disease (COPD) and mild-to-moderate sleep apnea. > > > >About Insomnia > > > >Approximately 60 million people in the United States suffer from insomnia, > >yet the vast > >majority remains undiagnosed and untreated. Insomnia is characterized by > >difficulty > >falling asleep, difficulty staying asleep, or poor quality sleep, leading > >to impairment of > >next-day functioning. > > > >Insomnia has been linked to a variety of health problems, including > >obesity, diabetes, > >hypertension, heart disease and depression. According to the U.S. Surgeon > >General, nearly > >$15 billion annually is spent on healthcare related to insomnia, while $50 > >billion is lost in > >productivity. > > > >About Rozerem > > > >Rozerem is indicated for the treatment of insomnia characterized by > >difficulty with sleep > >onset. Rozerem should not be used in patients with hypersensitivity to > >ramelteon or any > >components of the formulation. Rozerem can be prescribed for long-term > >use. However, > >failure of insomnia to remit after a reasonable period of time, worsening > >of insomnia, or > >the emergence of new cognitive or behavioral abnormalities after taking > >Rozerem should > >be evaluated, as such symptoms may be the result of an unrecognized > >underlying medical > >disorder. In primarily depressed patients, worsening of depression, > >including suicidal > >ideation, has been reported in association with the use of hypnotics. > > > >Rozerem should not be used by patients with severe hepatic impairment, or > >in patients in > >combination with fluvoxamine. > > > >Rozerem has not been studied in subjects with severe sleep apnea or severe > >COPD and is > >not recommended for use in those populations. Patients should be advised > >to exercise > >caution if they consume alcohol in combination with Rozerem. > > > >Rozerem has been associated with decreased testosterone levels and > >increased prolactin > >levels. As a result, healthcare professionals should be mindful of any > >unexplained > >symptoms possibly associated with such changes in these hormone levels. > >Rozerem has > >not been studied in children or adolescents, and the effects in these > >populations are > >unknown. > > > >Rozerem should be taken within 30 minutes before going to bed and > >activities should be > >confined to those necessary to prepare for bed. Rozerem should not be > >taken with or > >immediately after a high-fat meal. Engaging in hazardous activities that > >require > >concentration (such as operating a motor vehicle or heavy machinery) after > >taking > >Rozerem should be avoided. > > > >The most common adverse events seen with Rozerem that had greater than 2% > >incidence > >difference from placebo were somnolence, dizziness, and fatigue. > > > >For more information, please visit the Rozerem website. > > > > > > > > > > > >Opinions expressed are NOT meant to take the place of advice given by > >licensed health care professionals. Consult your physician or licensed > >health care professional before commencing any medical treatment. > > > > " Do not let either the medical authorities or the politicians mislead you. > >Find out what the facts are, and make your own decisions about how to live > >a happy life and how to work for a better world. " - Linus ing, > >two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace) > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 10, 2005 Report Share Posted October 10, 2005 Let me know if it helps you. Lynda At 08:52 PM 10/10/2005, you wrote: >Wow, Lynda. I have no idea. Melatonin never did anything for me. The >doc said this >would, so all I can do is give it a try! > > > > >Hey ladies, > > >I thought I would share something I found out today. I know many of us > > >have sleep > > >disturbances. I just got back from my doctor and explained the > problems I > > >was having > > >with sleep. I told him I did not want to take ambien because it is > > >habituating and does not > > >seem to work well for me anyway. My sleep schedule is so screwed up > since > > >I got sick, > > >that I know I do not get enough sleep, and usually can't get to sleep > > >until 3 AM or later. > > >This medication works on the 'melatonin' receptors, and is not addictive, > > >according to the > > >doc -- indeed, it seems to be the only sleep medication that is not > > >addictive (except for > > >antidepressant like Doxepin which gives me headaches). > > >I am going to try it for one week. > > > > > >He has prescribed this: > > >The U.S. Food and Drug Administration (FDA) has approved the New Drug > > >Application > > >(NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia > > >characterized > > >by difficulty with sleep onset. > > > > > >The FDA approval allows physicians to prescribe Rozerem for long-term use > > >in adults. > > > > > >Rozerem is the first and only prescription sleep medication that has > shown > > >no evidence of > > >abuse and dependence and, as a result, has not been designated as a > > >controlled substance > > >by the U.S. Drug Enforcement Administration (DEA). With the exception of > > >Rozerem, all > > >other prescription medications indicated for insomnia are classified as > > >Schedule IV > > >controlled substances by the DEA. Additionally, Rozerem is the first > > >prescription insomnia > > >medication with a new therapeutic mechanism of action in 35 years, and > > >will be available > > >for patients by late September. > > > > > >Rozerem has a unique therapeutic mechanism of action that selectively > > >targets two > > >receptors located in the brain's suprachiasmatic nucleus (SCN). The > SCN is > > >known as the > > >body's " master clock " because it regulates 24-hour, or circadian, rhythms > > >including the > > >sleep-wake cycle. > > > > > >The Rozerem NDA, submitted in September 2004 by Takeda Global Research & > > >Development Center, Inc., was based on data collected from an extensive > > >clinical research > > >program, including recently completed clinical studies with more than > > >4,200 patients ages > > >18 to 93. In one study, 472 patients received single daily doses of > > >Rozerem for up to one > > >year. Also, based on recently presented clinical trials, Rozerem has been > > >shown to be safe > > >for older adults, as well as those who have mild-to-moderate chronic > > >obstructive > > >pulmonary disease (COPD) and mild-to-moderate sleep apnea. > > > > > >About Insomnia > > > > > >Approximately 60 million people in the United States suffer from > insomnia, > > >yet the vast > > >majority remains undiagnosed and untreated. Insomnia is characterized by > > >difficulty > > >falling asleep, difficulty staying asleep, or poor quality sleep, leading > > >to impairment of > > >next-day functioning. > > > > > >Insomnia has been linked to a variety of health problems, including > > >obesity, diabetes, > > >hypertension, heart disease and depression. According to the U.S. Surgeon > > >General, nearly > > >$15 billion annually is spent on healthcare related to insomnia, while > $50 > > >billion is lost in > > >productivity. > > > > > >About Rozerem > > > > > >Rozerem is indicated for the treatment of insomnia characterized by > > >difficulty with sleep > > >onset. Rozerem should not be used in patients with hypersensitivity to > > >ramelteon or any > > >components of the formulation. Rozerem can be prescribed for long-term > > >use. However, > > >failure of insomnia to remit after a reasonable period of time, worsening > > >of insomnia, or > > >the emergence of new cognitive or behavioral abnormalities after taking > > >Rozerem should > > >be evaluated, as such symptoms may be the result of an unrecognized > > >underlying medical > > >disorder. In primarily depressed patients, worsening of depression, > > >including suicidal > > >ideation, has been reported in association with the use of hypnotics. > > > > > >Rozerem should not be used by patients with severe hepatic impairment, or > > >in patients in > > >combination with fluvoxamine. > > > > > >Rozerem has not been studied in subjects with severe sleep apnea or > severe > > >COPD and is > > >not recommended for use in those populations. Patients should be advised > > >to exercise > > >caution if they consume alcohol in combination with Rozerem. > > > > > >Rozerem has been associated with decreased testosterone levels and > > >increased prolactin > > >levels. As a result, healthcare professionals should be mindful of any > > >unexplained > > >symptoms possibly associated with such changes in these hormone levels. > > >Rozerem has > > >not been studied in children or adolescents, and the effects in these > > >populations are > > >unknown. > > > > > >Rozerem should be taken within 30 minutes before going to bed and > > >activities should be > > >confined to those necessary to prepare for bed. Rozerem should not be > > >taken with or > > >immediately after a high-fat meal. Engaging in hazardous activities that > > >require > > >concentration (such as operating a motor vehicle or heavy machinery) > after > > >taking > > >Rozerem should be avoided. > > > > > >The most common adverse events seen with Rozerem that had greater than 2% > > >incidence > > >difference from placebo were somnolence, dizziness, and fatigue. > > > > > >For more information, please visit the Rozerem website. > > > > > > > > > > > > > > > > > >Opinions expressed are NOT meant to take the place of advice given by > > >licensed health care professionals. Consult your physician or licensed > > >health care professional before commencing any medical treatment. > > > > > > " Do not let either the medical authorities or the politicians mislead > you. > > >Find out what the facts are, and make your own decisions about how to > live > > >a happy life and how to work for a better world. " - Linus ing, > > >two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace) > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 12, 2005 Report Share Posted October 12, 2005 Hello Ladies, I slept last night before 3 AM for the first time in recent memory. This sleep medication does help! I slept a full 8 hours, waking up only once but going back to sleep promptly. > > Hey ladies, > I thought I would share something I found out today. I know many of us have sleep > disturbances. I just got back from my doctor and explained the problems I was having > with sleep. I told him I did not want to take ambien because it is habituating and does not > seem to work well for me anyway. My sleep schedule is so screwed up since I got sick, > that I know I do not get enough sleep, and usually can't get to sleep until 3 AM or later. > This medication works on the 'melatonin' receptors, and is not addictive, according to the > doc -- indeed, it seems to be the only sleep medication that is not addictive (except for > antidepressant like Doxepin which gives me headaches). > I am going to try it for one week. > > He has prescribed this: > The U.S. Food and Drug Administration (FDA) has approved the New Drug Application > (NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia characterized > by difficulty with sleep onset. > > The FDA approval allows physicians to prescribe Rozerem for long-term use in adults. > > Rozerem is the first and only prescription sleep medication that has shown no evidence of > abuse and dependence and, as a result, has not been designated as a controlled substance > by the U.S. Drug Enforcement Administration (DEA). With the exception of Rozerem, all > other prescription medications indicated for insomnia are classified as Schedule IV > controlled substances by the DEA. Additionally, Rozerem is the first prescription insomnia > medication with a new therapeutic mechanism of action in 35 years, and will be available > for patients by late September. > > Rozerem has a unique therapeutic mechanism of action that selectively targets two > receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the > body's " master clock " because it regulates 24-hour, or circadian, rhythms including the > sleep-wake cycle. > > The Rozerem NDA, submitted in September 2004 by Takeda Global Research & > Development Center, Inc., was based on data collected from an extensive clinical research > program, including recently completed clinical studies with more than 4,200 patients ages > 18 to 93. In one study, 472 patients received single daily doses of Rozerem for up to one > year. Also, based on recently presented clinical trials, Rozerem has been shown to be safe > for older adults, as well as those who have mild-to-moderate chronic obstructive > pulmonary disease (COPD) and mild-to-moderate sleep apnea. > > About Insomnia > > Approximately 60 million people in the United States suffer from insomnia, yet the vast > majority remains undiagnosed and untreated. Insomnia is characterized by difficulty > falling asleep, difficulty staying asleep, or poor quality sleep, leading to impairment of > next-day functioning. > > Insomnia has been linked to a variety of health problems, including obesity, diabetes, > hypertension, heart disease and depression. According to the U.S. Surgeon General, nearly > $15 billion annually is spent on healthcare related to insomnia, while $50 billion is lost in > productivity. > > About Rozerem > > Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep > onset. Rozerem should not be used in patients with hypersensitivity to ramelteon or any > components of the formulation. Rozerem can be prescribed for long-term use. However, > failure of insomnia to remit after a reasonable period of time, worsening of insomnia, or > the emergence of new cognitive or behavioral abnormalities after taking Rozerem should > be evaluated, as such symptoms may be the result of an unrecognized underlying medical > disorder. In primarily depressed patients, worsening of depression, including suicidal > ideation, has been reported in association with the use of hypnotics. > > Rozerem should not be used by patients with severe hepatic impairment, or in patients in > combination with fluvoxamine. > > Rozerem has not been studied in subjects with severe sleep apnea or severe COPD and is > not recommended for use in those populations. Patients should be advised to exercise > caution if they consume alcohol in combination with Rozerem. > > Rozerem has been associated with decreased testosterone levels and increased prolactin > levels. As a result, healthcare professionals should be mindful of any unexplained > symptoms possibly associated with such changes in these hormone levels. Rozerem has > not been studied in children or adolescents, and the effects in these populations are > unknown. > > Rozerem should be taken within 30 minutes before going to bed and activities should be > confined to those necessary to prepare for bed. Rozerem should not be taken with or > immediately after a high-fat meal. Engaging in hazardous activities that require > concentration (such as operating a motor vehicle or heavy machinery) after taking > Rozerem should be avoided. > > The most common adverse events seen with Rozerem that had greater than 2% incidence > difference from placebo were somnolence, dizziness, and fatigue. > > For more information, please visit the Rozerem website. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 12, 2005 Report Share Posted October 12, 2005 What kind of med is it I have never heard of it before? n , " MollyBloom54 " <mollyb54@b...> wrote: > > Hello Ladies, > I slept last night before 3 AM for the first time in recent memory. This sleep medication > does help! > I slept a full 8 hours, waking up only once but going back to sleep promptly. > > > > --- In , " MollyBloom54 " <mollyb54@b...> wrote: > > > > Hey ladies, > > I thought I would share something I found out today. I know many of us have sleep > > disturbances. I just got back from my doctor and explained the problems I was having > > with sleep. I told him I did not want to take ambien because it is habituating and does > not > > seem to work well for me anyway. My sleep schedule is so screwed up since I got sick, > > that I know I do not get enough sleep, and usually can't get to sleep until 3 AM or later. > > This medication works on the 'melatonin' receptors, and is not addictive, according to > the > > doc -- indeed, it seems to be the only sleep medication that is not addictive (except for > > antidepressant like Doxepin which gives me headaches). > > I am going to try it for one week. > > > > He has prescribed this: > > The U.S. Food and Drug Administration (FDA) has approved the New Drug Application > > (NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia > characterized > > by difficulty with sleep onset. > > > > The FDA approval allows physicians to prescribe Rozerem for long-term use in adults. > > > > Rozerem is the first and only prescription sleep medication that has shown no evidence > of > > abuse and dependence and, as a result, has not been designated as a controlled > substance > > by the U.S. Drug Enforcement Administration (DEA). With the exception of Rozerem, all > > other prescription medications indicated for insomnia are classified as Schedule IV > > controlled substances by the DEA. Additionally, Rozerem is the first prescription > insomnia > > medication with a new therapeutic mechanism of action in 35 years, and will be > available > > for patients by late September. > > > > Rozerem has a unique therapeutic mechanism of action that selectively targets two > > receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the > > body's " master clock " because it regulates 24-hour, or circadian, rhythms including the > > sleep-wake cycle. > > > > The Rozerem NDA, submitted in September 2004 by Takeda Global Research & > > Development Center, Inc., was based on data collected from an extensive clinical > research > > program, including recently completed clinical studies with more than 4,200 patients > ages > > 18 to 93. In one study, 472 patients received single daily doses of Rozerem for up to > one > > year. Also, based on recently presented clinical trials, Rozerem has been shown to be > safe > > for older adults, as well as those who have mild-to-moderate chronic obstructive > > pulmonary disease (COPD) and mild-to-moderate sleep apnea. > > > > About Insomnia > > > > Approximately 60 million people in the United States suffer from insomnia, yet the vast > > majority remains undiagnosed and untreated. Insomnia is characterized by difficulty > > falling asleep, difficulty staying asleep, or poor quality sleep, leading to impairment of > > next-day functioning. > > > > Insomnia has been linked to a variety of health problems, including obesity, diabetes, > > hypertension, heart disease and depression. According to the U.S. Surgeon General, > nearly > > $15 billion annually is spent on healthcare related to insomnia, while $50 billion is lost > in > > productivity. > > > > About Rozerem > > > > Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep > > onset. Rozerem should not be used in patients with hypersensitivity to ramelteon or any > > components of the formulation. Rozerem can be prescribed for long-term use. However, > > failure of insomnia to remit after a reasonable period of time, worsening of insomnia, or > > the emergence of new cognitive or behavioral abnormalities after taking Rozerem > should > > be evaluated, as such symptoms may be the result of an unrecognized underlying > medical > > disorder. In primarily depressed patients, worsening of depression, including suicidal > > ideation, has been reported in association with the use of hypnotics. > > > > Rozerem should not be used by patients with severe hepatic impairment, or in patients > in > > combination with fluvoxamine. > > > > Rozerem has not been studied in subjects with severe sleep apnea or severe COPD and > is > > not recommended for use in those populations. Patients should be advised to exercise > > caution if they consume alcohol in combination with Rozerem. > > > > Rozerem has been associated with decreased testosterone levels and increased prolactin > > levels. As a result, healthcare professionals should be mindful of any unexplained > > symptoms possibly associated with such changes in these hormone levels. Rozerem has > > not been studied in children or adolescents, and the effects in these populations are > > unknown. > > > > Rozerem should be taken within 30 minutes before going to bed and activities should > be > > confined to those necessary to prepare for bed. Rozerem should not be taken with or > > immediately after a high-fat meal. Engaging in hazardous activities that require > > concentration (such as operating a motor vehicle or heavy machinery) after taking > > Rozerem should be avoided. > > > > The most common adverse events seen with Rozerem that had greater than 2% > incidence > > difference from placebo were somnolence, dizziness, and fatigue. > > > > For more information, please visit the Rozerem website. > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 12, 2005 Report Share Posted October 12, 2005 It is a new sleep medication, that is supposedly unlike any others in that it acts on the 'melatonin' receptors and is non-addictive. I am pleased that it helped me last night. My doc pointed out that a lot of the fibro problems will be helped by better sleep. I will see how it works in the next week. > > > > > > Hey ladies, > > > I thought I would share something I found out today. I know many > of us have sleep > > > disturbances. I just got back from my doctor and explained the > problems I was having > > > with sleep. I told him I did not want to take ambien because it > is habituating and does > > not > > > seem to work well for me anyway. My sleep schedule is so screwed > up since I got sick, > > > that I know I do not get enough sleep, and usually can't get to > sleep until 3 AM or later. > > > This medication works on the 'melatonin' receptors, and is not > addictive, according to > > the > > > doc -- indeed, it seems to be the only sleep medication that is > not addictive (except for > > > antidepressant like Doxepin which gives me headaches). > > > I am going to try it for one week. > > > > > > He has prescribed this: > > > The U.S. Food and Drug Administration (FDA) has approved the New > Drug Application > > > (NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of > insomnia > > characterized > > > by difficulty with sleep onset. > > > > > > The FDA approval allows physicians to prescribe Rozerem for > long-term use in adults. > > > > > > Rozerem is the first and only prescription sleep medication that > has shown no evidence > > of > > > abuse and dependence and, as a result, has not been designated as > a controlled > > substance > > > by the U.S. Drug Enforcement Administration (DEA). With the > exception of Rozerem, all > > > other prescription medications indicated for insomnia are > classified as Schedule IV > > > controlled substances by the DEA. Additionally, Rozerem is the > first prescription > > insomnia > > > medication with a new therapeutic mechanism of action in 35 years, > and will be > > available > > > for patients by late September. > > > > > > Rozerem has a unique therapeutic mechanism of action that > selectively targets two > > > receptors located in the brain's suprachiasmatic nucleus (SCN). > The SCN is known as the > > > body's " master clock " because it regulates 24-hour, or circadian, > rhythms including the > > > sleep-wake cycle. > > > > > > The Rozerem NDA, submitted in September 2004 by Takeda Global > Research & > > > Development Center, Inc., was based on data collected from an > extensive clinical > > research > > > program, including recently completed clinical studies with more > than 4,200 patients > > ages > > > 18 to 93. In one study, 472 patients received single daily doses > of Rozerem for up to > > one > > > year. Also, based on recently presented clinical trials, Rozerem > has been shown to be > > safe > > > for older adults, as well as those who have mild-to-moderate > chronic obstructive > > > pulmonary disease (COPD) and mild-to-moderate sleep apnea. > > > > > > About Insomnia > > > > > > Approximately 60 million people in the United States suffer from > insomnia, yet the vast > > > majority remains undiagnosed and untreated. Insomnia is > characterized by difficulty > > > falling asleep, difficulty staying asleep, or poor quality sleep, > leading to impairment of > > > next-day functioning. > > > > > > Insomnia has been linked to a variety of health problems, > including obesity, diabetes, > > > hypertension, heart disease and depression. According to the U.S. > Surgeon General, > > nearly > > > $15 billion annually is spent on healthcare related to insomnia, > while $50 billion is lost > > in > > > productivity. > > > > > > About Rozerem > > > > > > Rozerem is indicated for the treatment of insomnia characterized > by difficulty with sleep > > > onset. Rozerem should not be used in patients with > hypersensitivity to ramelteon or any > > > components of the formulation. Rozerem can be prescribed for > long-term use. However, > > > failure of insomnia to remit after a reasonable period of time, > worsening of insomnia, or > > > the emergence of new cognitive or behavioral abnormalities after > taking Rozerem > > should > > > be evaluated, as such symptoms may be the result of an > unrecognized underlying > > medical > > > disorder. In primarily depressed patients, worsening of > depression, including suicidal > > > ideation, has been reported in association with the use of hypnotics. > > > > > > Rozerem should not be used by patients with severe hepatic > impairment, or in patients > > in > > > combination with fluvoxamine. > > > > > > Rozerem has not been studied in subjects with severe sleep apnea > or severe COPD and > > is > > > not recommended for use in those populations. Patients should be > advised to exercise > > > caution if they consume alcohol in combination with Rozerem. > > > > > > Rozerem has been associated with decreased testosterone levels and > increased prolactin > > > levels. As a result, healthcare professionals should be mindful of > any unexplained > > > symptoms possibly associated with such changes in these hormone > levels. Rozerem has > > > not been studied in children or adolescents, and the effects in > these populations are > > > unknown. > > > > > > Rozerem should be taken within 30 minutes before going to bed and > activities should > > be > > > confined to those necessary to prepare for bed. Rozerem should not > be taken with or > > > immediately after a high-fat meal. Engaging in hazardous > activities that require > > > concentration (such as operating a motor vehicle or heavy > machinery) after taking > > > Rozerem should be avoided. > > > > > > The most common adverse events seen with Rozerem that had greater > than 2% > > incidence > > > difference from placebo were somnolence, dizziness, and fatigue. > > > > > > For more information, please visit the Rozerem website. > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 12, 2005 Report Share Posted October 12, 2005 It is a new sleep medication, that is supposedly unlike any others in that it acts on the 'melatonin' receptors and is non-addictive. I am pleased that it helped me last night. My doc pointed out that a lot of the fibro problems will be helped by better sleep. I will see how it works in the next week. > > > > > > Hey ladies, > > > I thought I would share something I found out today. I know many > of us have sleep > > > disturbances. I just got back from my doctor and explained the > problems I was having > > > with sleep. I told him I did not want to take ambien because it > is habituating and does > > not > > > seem to work well for me anyway. My sleep schedule is so screwed > up since I got sick, > > > that I know I do not get enough sleep, and usually can't get to > sleep until 3 AM or later. > > > This medication works on the 'melatonin' receptors, and is not > addictive, according to > > the > > > doc -- indeed, it seems to be the only sleep medication that is > not addictive (except for > > > antidepressant like Doxepin which gives me headaches). > > > I am going to try it for one week. > > > > > > He has prescribed this: > > > The U.S. Food and Drug Administration (FDA) has approved the New > Drug Application > > > (NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of > insomnia > > characterized > > > by difficulty with sleep onset. > > > > > > The FDA approval allows physicians to prescribe Rozerem for > long-term use in adults. > > > > > > Rozerem is the first and only prescription sleep medication that > has shown no evidence > > of > > > abuse and dependence and, as a result, has not been designated as > a controlled > > substance > > > by the U.S. Drug Enforcement Administration (DEA). With the > exception of Rozerem, all > > > other prescription medications indicated for insomnia are > classified as Schedule IV > > > controlled substances by the DEA. Additionally, Rozerem is the > first prescription > > insomnia > > > medication with a new therapeutic mechanism of action in 35 years, > and will be > > available > > > for patients by late September. > > > > > > Rozerem has a unique therapeutic mechanism of action that > selectively targets two > > > receptors located in the brain's suprachiasmatic nucleus (SCN). > The SCN is known as the > > > body's " master clock " because it regulates 24-hour, or circadian, > rhythms including the > > > sleep-wake cycle. > > > > > > The Rozerem NDA, submitted in September 2004 by Takeda Global > Research & > > > Development Center, Inc., was based on data collected from an > extensive clinical > > research > > > program, including recently completed clinical studies with more > than 4,200 patients > > ages > > > 18 to 93. In one study, 472 patients received single daily doses > of Rozerem for up to > > one > > > year. Also, based on recently presented clinical trials, Rozerem > has been shown to be > > safe > > > for older adults, as well as those who have mild-to-moderate > chronic obstructive > > > pulmonary disease (COPD) and mild-to-moderate sleep apnea. > > > > > > About Insomnia > > > > > > Approximately 60 million people in the United States suffer from > insomnia, yet the vast > > > majority remains undiagnosed and untreated. Insomnia is > characterized by difficulty > > > falling asleep, difficulty staying asleep, or poor quality sleep, > leading to impairment of > > > next-day functioning. > > > > > > Insomnia has been linked to a variety of health problems, > including obesity, diabetes, > > > hypertension, heart disease and depression. According to the U.S. > Surgeon General, > > nearly > > > $15 billion annually is spent on healthcare related to insomnia, > while $50 billion is lost > > in > > > productivity. > > > > > > About Rozerem > > > > > > Rozerem is indicated for the treatment of insomnia characterized > by difficulty with sleep > > > onset. Rozerem should not be used in patients with > hypersensitivity to ramelteon or any > > > components of the formulation. Rozerem can be prescribed for > long-term use. However, > > > failure of insomnia to remit after a reasonable period of time, > worsening of insomnia, or > > > the emergence of new cognitive or behavioral abnormalities after > taking Rozerem > > should > > > be evaluated, as such symptoms may be the result of an > unrecognized underlying > > medical > > > disorder. In primarily depressed patients, worsening of > depression, including suicidal > > > ideation, has been reported in association with the use of hypnotics. > > > > > > Rozerem should not be used by patients with severe hepatic > impairment, or in patients > > in > > > combination with fluvoxamine. > > > > > > Rozerem has not been studied in subjects with severe sleep apnea > or severe COPD and > > is > > > not recommended for use in those populations. Patients should be > advised to exercise > > > caution if they consume alcohol in combination with Rozerem. > > > > > > Rozerem has been associated with decreased testosterone levels and > increased prolactin > > > levels. As a result, healthcare professionals should be mindful of > any unexplained > > > symptoms possibly associated with such changes in these hormone > levels. Rozerem has > > > not been studied in children or adolescents, and the effects in > these populations are > > > unknown. > > > > > > Rozerem should be taken within 30 minutes before going to bed and > activities should > > be > > > confined to those necessary to prepare for bed. Rozerem should not > be taken with or > > > immediately after a high-fat meal. Engaging in hazardous > activities that require > > > concentration (such as operating a motor vehicle or heavy > machinery) after taking > > > Rozerem should be avoided. > > > > > > The most common adverse events seen with Rozerem that had greater > than 2% > > incidence > > > difference from placebo were somnolence, dizziness, and fatigue. > > > > > > For more information, please visit the Rozerem website. > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 13, 2005 Report Share Posted October 13, 2005 To Tina, This might sound like a less appealing solution, but what about having the larger breast made smaller to match the other one? It's still surgery and it's still spending money, but you'll be guaranteed that down the road you won't be trying to sort out which aliments are being caused by what. At the very least you will need another surgery at some point to replace the implant as it ages. I am one of the ones who are happy with my implants but must now have them removed because they are old, ruptured, and leaking. To not look strange after they are out I now have to have the lift as well. I feel guilty that my vanity (for lack of wanting to search for a word that disects the motives anyone gets them) is now going to cost my family a lot of money that should be going elsewhere. Just some thoughts I thought I'd throw out. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 13, 2005 Report Share Posted October 13, 2005 That was one of the suggestions already made and it does make the best sense to me.....but we all have to make our own choices. It can be hard when we have learned to make so much about our breast size. In reality I have learned that I am beautiful with or with out large breasts. In , Charlotte or Joe Hunt <chiandjoe@s...> wrote: > > To Tina, This might sound like a less appealing solution, but what about having the larger breast made smaller to match the other one? It's still surgery and it's still spending money, but you'll be guaranteed that down the road you won't be trying to sort out which aliments are being caused by what. At the very least you will need another surgery at some point to replace the implant as it ages. I am one of the ones who are happy with my implants but must now have them removed because they are old, ruptured, and leaking. To not look strange after they are out I now have to have the lift as well. I feel guilty that my vanity (for lack of wanting to search for a word that disects the motives anyone gets them) is now going to cost my family a lot of money that should be going elsewhere. Just some thoughts I thought I'd throw out. > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2005 Report Share Posted October 20, 2005 Molly, how is this new sleep medication working? Lynda At 08:39 PM 10/10/2005, you wrote: >Hey ladies, >I thought I would share something I found out today. I know many of us >have sleep >disturbances. I just got back from my doctor and explained the problems I >was having >with sleep. I told him I did not want to take ambien because it is >habituating and does not >seem to work well for me anyway. My sleep schedule is so screwed up since >I got sick, >that I know I do not get enough sleep, and usually can't get to sleep >until 3 AM or later. >This medication works on the 'melatonin' receptors, and is not addictive, >according to the >doc -- indeed, it seems to be the only sleep medication that is not >addictive (except for >antidepressant like Doxepin which gives me headaches). >I am going to try it for one week. > >He has prescribed this: >The U.S. Food and Drug Administration (FDA) has approved the New Drug >Application >(NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia >characterized >by difficulty with sleep onset. > >The FDA approval allows physicians to prescribe Rozerem for long-term use >in adults. > >Rozerem is the first and only prescription sleep medication that has shown >no evidence of >abuse and dependence and, as a result, has not been designated as a >controlled substance >by the U.S. Drug Enforcement Administration (DEA). With the exception of >Rozerem, all >other prescription medications indicated for insomnia are classified as >Schedule IV >controlled substances by the DEA. Additionally, Rozerem is the first >prescription insomnia >medication with a new therapeutic mechanism of action in 35 years, and >will be available >for patients by late September. > >Rozerem has a unique therapeutic mechanism of action that selectively >targets two >receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is >known as the >body's " master clock " because it regulates 24-hour, or circadian, rhythms >including the >sleep-wake cycle. > >The Rozerem NDA, submitted in September 2004 by Takeda Global Research & >Development Center, Inc., was based on data collected from an extensive >clinical research >program, including recently completed clinical studies with more than >4,200 patients ages >18 to 93. In one study, 472 patients received single daily doses of >Rozerem for up to one >year. Also, based on recently presented clinical trials, Rozerem has been >shown to be safe >for older adults, as well as those who have mild-to-moderate chronic >obstructive >pulmonary disease (COPD) and mild-to-moderate sleep apnea. > >About Insomnia > >Approximately 60 million people in the United States suffer from insomnia, >yet the vast >majority remains undiagnosed and untreated. Insomnia is characterized by >difficulty >falling asleep, difficulty staying asleep, or poor quality sleep, leading >to impairment of >next-day functioning. > >Insomnia has been linked to a variety of health problems, including >obesity, diabetes, >hypertension, heart disease and depression. According to the U.S. Surgeon >General, nearly >$15 billion annually is spent on healthcare related to insomnia, while $50 >billion is lost in >productivity. > >About Rozerem > >Rozerem is indicated for the treatment of insomnia characterized by >difficulty with sleep >onset. Rozerem should not be used in patients with hypersensitivity to >ramelteon or any >components of the formulation. Rozerem can be prescribed for long-term >use. However, >failure of insomnia to remit after a reasonable period of time, worsening >of insomnia, or >the emergence of new cognitive or behavioral abnormalities after taking >Rozerem should >be evaluated, as such symptoms may be the result of an unrecognized >underlying medical >disorder. In primarily depressed patients, worsening of depression, >including suicidal >ideation, has been reported in association with the use of hypnotics. > >Rozerem should not be used by patients with severe hepatic impairment, or >in patients in >combination with fluvoxamine. > >Rozerem has not been studied in subjects with severe sleep apnea or severe >COPD and is >not recommended for use in those populations. Patients should be advised >to exercise >caution if they consume alcohol in combination with Rozerem. > >Rozerem has been associated with decreased testosterone levels and >increased prolactin >levels. As a result, healthcare professionals should be mindful of any >unexplained >symptoms possibly associated with such changes in these hormone levels. >Rozerem has >not been studied in children or adolescents, and the effects in these >populations are >unknown. > >Rozerem should be taken within 30 minutes before going to bed and >activities should be >confined to those necessary to prepare for bed. Rozerem should not be >taken with or >immediately after a high-fat meal. Engaging in hazardous activities that >require >concentration (such as operating a motor vehicle or heavy machinery) after >taking >Rozerem should be avoided. > >The most common adverse events seen with Rozerem that had greater than 2% >incidence >difference from placebo were somnolence, dizziness, and fatigue. > >For more information, please visit the Rozerem website. > > > > > >Opinions expressed are NOT meant to take the place of advice given by >licensed health care professionals. Consult your physician or licensed >health care professional before commencing any medical treatment. > > " Do not let either the medical authorities or the politicians mislead you. >Find out what the facts are, and make your own decisions about how to live >a happy life and how to work for a better world. " - Linus ing, >two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace) > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2005 Report Share Posted October 20, 2005 Not very well. My doc put me on Seroquil, which at low doses is prescribed for sleep. The jury's still out on this. I still have problems getting to and staying asleep. I have to schedule a sleep test this week. > >Hey ladies, > >I thought I would share something I found out today. I know many of us > >have sleep > >disturbances. I just got back from my doctor and explained the problems I > >was having > >with sleep. I told him I did not want to take ambien because it is > >habituating and does not > >seem to work well for me anyway. My sleep schedule is so screwed up since > >I got sick, > >that I know I do not get enough sleep, and usually can't get to sleep > >until 3 AM or later. > >This medication works on the 'melatonin' receptors, and is not addictive, > >according to the > >doc -- indeed, it seems to be the only sleep medication that is not > >addictive (except for > >antidepressant like Doxepin which gives me headaches). > >I am going to try it for one week. > > > >He has prescribed this: > >The U.S. Food and Drug Administration (FDA) has approved the New Drug > >Application > >(NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia > >characterized > >by difficulty with sleep onset. > > > >The FDA approval allows physicians to prescribe Rozerem for long-term use > >in adults. > > > >Rozerem is the first and only prescription sleep medication that has shown > >no evidence of > >abuse and dependence and, as a result, has not been designated as a > >controlled substance > >by the U.S. Drug Enforcement Administration (DEA). With the exception of > >Rozerem, all > >other prescription medications indicated for insomnia are classified as > >Schedule IV > >controlled substances by the DEA. Additionally, Rozerem is the first > >prescription insomnia > >medication with a new therapeutic mechanism of action in 35 years, and > >will be available > >for patients by late September. > > > >Rozerem has a unique therapeutic mechanism of action that selectively > >targets two > >receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is > >known as the > >body's " master clock " because it regulates 24-hour, or circadian, rhythms > >including the > >sleep-wake cycle. > > > >The Rozerem NDA, submitted in September 2004 by Takeda Global Research & > >Development Center, Inc., was based on data collected from an extensive > >clinical research > >program, including recently completed clinical studies with more than > >4,200 patients ages > >18 to 93. In one study, 472 patients received single daily doses of > >Rozerem for up to one > >year. Also, based on recently presented clinical trials, Rozerem has been > >shown to be safe > >for older adults, as well as those who have mild-to-moderate chronic > >obstructive > >pulmonary disease (COPD) and mild-to-moderate sleep apnea. > > > >About Insomnia > > > >Approximately 60 million people in the United States suffer from insomnia, > >yet the vast > >majority remains undiagnosed and untreated. Insomnia is characterized by > >difficulty > >falling asleep, difficulty staying asleep, or poor quality sleep, leading > >to impairment of > >next-day functioning. > > > >Insomnia has been linked to a variety of health problems, including > >obesity, diabetes, > >hypertension, heart disease and depression. According to the U.S. Surgeon > >General, nearly > >$15 billion annually is spent on healthcare related to insomnia, while $50 > >billion is lost in > >productivity. > > > >About Rozerem > > > >Rozerem is indicated for the treatment of insomnia characterized by > >difficulty with sleep > >onset. Rozerem should not be used in patients with hypersensitivity to > >ramelteon or any > >components of the formulation. Rozerem can be prescribed for long-term > >use. However, > >failure of insomnia to remit after a reasonable period of time, worsening > >of insomnia, or > >the emergence of new cognitive or behavioral abnormalities after taking > >Rozerem should > >be evaluated, as such symptoms may be the result of an unrecognized > >underlying medical > >disorder. In primarily depressed patients, worsening of depression, > >including suicidal > >ideation, has been reported in association with the use of hypnotics. > > > >Rozerem should not be used by patients with severe hepatic impairment, or > >in patients in > >combination with fluvoxamine. > > > >Rozerem has not been studied in subjects with severe sleep apnea or severe > >COPD and is > >not recommended for use in those populations. Patients should be advised > >to exercise > >caution if they consume alcohol in combination with Rozerem. > > > >Rozerem has been associated with decreased testosterone levels and > >increased prolactin > >levels. As a result, healthcare professionals should be mindful of any > >unexplained > >symptoms possibly associated with such changes in these hormone levels. > >Rozerem has > >not been studied in children or adolescents, and the effects in these > >populations are > >unknown. > > > >Rozerem should be taken within 30 minutes before going to bed and > >activities should be > >confined to those necessary to prepare for bed. Rozerem should not be > >taken with or > >immediately after a high-fat meal. Engaging in hazardous activities that > >require > >concentration (such as operating a motor vehicle or heavy machinery) after > >taking > >Rozerem should be avoided. > > > >The most common adverse events seen with Rozerem that had greater than 2% > >incidence > >difference from placebo were somnolence, dizziness, and fatigue. > > > >For more information, please visit the Rozerem website. > > > > > > > > > > > >Opinions expressed are NOT meant to take the place of advice given by > >licensed health care professionals. Consult your physician or licensed > >health care professional before commencing any medical treatment. > > > > " Do not let either the medical authorities or the politicians mislead you. > >Find out what the facts are, and make your own decisions about how to live > >a happy life and how to work for a better world. " - Linus ing, > >two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace) > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2005 Report Share Posted October 20, 2005 Molly, talk to your doctor about the 5HTP we discussed earlier, it is useful for sleep problems as well! Kenda > Not very well. My doc put me on Seroquil, which at low doses is prescribed > for sleep. > The jury's still out on this. I still have problems getting to and staying > asleep. > I have to schedule a sleep test this week. > > >>> Hey ladies, >>> I thought I would share something I found out today. I know many of us >>> have sleep >>> disturbances. I just got back from my doctor and explained the problems I >>> was having >>> with sleep. I told him I did not want to take ambien because it is >>> habituating and does not >>> seem to work well for me anyway. My sleep schedule is so screwed up since >>> I got sick, >>> that I know I do not get enough sleep, and usually can't get to sleep >>> until 3 AM or later. >>> This medication works on the 'melatonin' receptors, and is not addictive, >>> according to the >>> doc -- indeed, it seems to be the only sleep medication that is not >>> addictive (except for >>> antidepressant like Doxepin which gives me headaches). >>> I am going to try it for one week. >>> >>> He has prescribed this: >>> The U.S. Food and Drug Administration (FDA) has approved the New Drug >>> Application >>> (NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia >>> characterized >>> by difficulty with sleep onset. >>> >>> The FDA approval allows physicians to prescribe Rozerem for long-term use >>> in adults. >>> >>> Rozerem is the first and only prescription sleep medication that has shown >>> no evidence of >>> abuse and dependence and, as a result, has not been designated as a >>> controlled substance >>> by the U.S. Drug Enforcement Administration (DEA). With the exception of >>> Rozerem, all >>> other prescription medications indicated for insomnia are classified as >>> Schedule IV >>> controlled substances by the DEA. Additionally, Rozerem is the first >>> prescription insomnia >>> medication with a new therapeutic mechanism of action in 35 years, and >>> will be available >>> for patients by late September. >>> >>> Rozerem has a unique therapeutic mechanism of action that selectively >>> targets two >>> receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is >>> known as the >>> body's " master clock " because it regulates 24-hour, or circadian, rhythms >>> including the >>> sleep-wake cycle. >>> >>> The Rozerem NDA, submitted in September 2004 by Takeda Global Research & >>> Development Center, Inc., was based on data collected from an extensive >>> clinical research >>> program, including recently completed clinical studies with more than >>> 4,200 patients ages >>> 18 to 93. In one study, 472 patients received single daily doses of >>> Rozerem for up to one >>> year. Also, based on recently presented clinical trials, Rozerem has been >>> shown to be safe >>> for older adults, as well as those who have mild-to-moderate chronic >>> obstructive >>> pulmonary disease (COPD) and mild-to-moderate sleep apnea. >>> >>> About Insomnia >>> >>> Approximately 60 million people in the United States suffer from insomnia, >>> yet the vast >>> majority remains undiagnosed and untreated. Insomnia is characterized by >>> difficulty >>> falling asleep, difficulty staying asleep, or poor quality sleep, leading >>> to impairment of >>> next-day functioning. >>> >>> Insomnia has been linked to a variety of health problems, including >>> obesity, diabetes, >>> hypertension, heart disease and depression. According to the U.S. Surgeon >>> General, nearly >>> $15 billion annually is spent on healthcare related to insomnia, while $50 >>> billion is lost in >>> productivity. >>> >>> About Rozerem >>> >>> Rozerem is indicated for the treatment of insomnia characterized by >>> difficulty with sleep >>> onset. Rozerem should not be used in patients with hypersensitivity to >>> ramelteon or any >>> components of the formulation. Rozerem can be prescribed for long-term >>> use. However, >>> failure of insomnia to remit after a reasonable period of time, worsening >>> of insomnia, or >>> the emergence of new cognitive or behavioral abnormalities after taking >>> Rozerem should >>> be evaluated, as such symptoms may be the result of an unrecognized >>> underlying medical >>> disorder. In primarily depressed patients, worsening of depression, >>> including suicidal >>> ideation, has been reported in association with the use of hypnotics. >>> >>> Rozerem should not be used by patients with severe hepatic impairment, or >>> in patients in >>> combination with fluvoxamine. >>> >>> Rozerem has not been studied in subjects with severe sleep apnea or severe >>> COPD and is >>> not recommended for use in those populations. Patients should be advised >>> to exercise >>> caution if they consume alcohol in combination with Rozerem. >>> >>> Rozerem has been associated with decreased testosterone levels and >>> increased prolactin >>> levels. As a result, healthcare professionals should be mindful of any >>> unexplained >>> symptoms possibly associated with such changes in these hormone levels. >>> Rozerem has >>> not been studied in children or adolescents, and the effects in these >>> populations are >>> unknown. >>> >>> Rozerem should be taken within 30 minutes before going to bed and >>> activities should be >>> confined to those necessary to prepare for bed. Rozerem should not be >>> taken with or >>> immediately after a high-fat meal. Engaging in hazardous activities that >>> require >>> concentration (such as operating a motor vehicle or heavy machinery) after >>> taking >>> Rozerem should be avoided. >>> >>> The most common adverse events seen with Rozerem that had greater than 2% >>> incidence >>> difference from placebo were somnolence, dizziness, and fatigue. >>> >>> For more information, please visit the Rozerem website. >>> >>> >>> >>> >>> >>> Opinions expressed are NOT meant to take the place of advice given by >>> licensed health care professionals. Consult your physician or licensed >>> health care professional before commencing any medical treatment. >>> >>> " Do not let either the medical authorities or the politicians mislead you. >>> Find out what the facts are, and make your own decisions about how to live >>> a happy life and how to work for a better world. " - Linus ing, >>> two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace) >>> >>> Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 20, 2005 Report Share Posted October 20, 2005 I will! I am not happy about the Seroquil. My internist today said she didn't think it was a good sleep medication - it is primarily prescribed for bi-polar disorder, which I do not have, but an 'off' label use is for insomnia. My internist said long term it can create parkinson type illness. I don't' like that idea!! > >>> Hey ladies, > >>> I thought I would share something I found out today. I know many of us > >>> have sleep > >>> disturbances. I just got back from my doctor and explained the problems I > >>> was having > >>> with sleep. I told him I did not want to take ambien because it is > >>> habituating and does not > >>> seem to work well for me anyway. My sleep schedule is so screwed up since > >>> I got sick, > >>> that I know I do not get enough sleep, and usually can't get to sleep > >>> until 3 AM or later. > >>> This medication works on the 'melatonin' receptors, and is not addictive, > >>> according to the > >>> doc -- indeed, it seems to be the only sleep medication that is not > >>> addictive (except for > >>> antidepressant like Doxepin which gives me headaches). > >>> I am going to try it for one week. > >>> > >>> He has prescribed this: > >>> The U.S. Food and Drug Administration (FDA) has approved the New Drug > >>> Application > >>> (NDA) for Rozerem (ramelteon) 8-mg tablets for the treatment of insomnia > >>> characterized > >>> by difficulty with sleep onset. > >>> > >>> The FDA approval allows physicians to prescribe Rozerem for long-term use > >>> in adults. > >>> > >>> Rozerem is the first and only prescription sleep medication that has shown > >>> no evidence of > >>> abuse and dependence and, as a result, has not been designated as a > >>> controlled substance > >>> by the U.S. Drug Enforcement Administration (DEA). With the exception of > >>> Rozerem, all > >>> other prescription medications indicated for insomnia are classified as > >>> Schedule IV > >>> controlled substances by the DEA. Additionally, Rozerem is the first > >>> prescription insomnia > >>> medication with a new therapeutic mechanism of action in 35 years, and > >>> will be available > >>> for patients by late September. > >>> > >>> Rozerem has a unique therapeutic mechanism of action that selectively > >>> targets two > >>> receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is > >>> known as the > >>> body's " master clock " because it regulates 24-hour, or circadian, rhythms > >>> including the > >>> sleep-wake cycle. > >>> > >>> The Rozerem NDA, submitted in September 2004 by Takeda Global Research & > >>> Development Center, Inc., was based on data collected from an extensive > >>> clinical research > >>> program, including recently completed clinical studies with more than > >>> 4,200 patients ages > >>> 18 to 93. In one study, 472 patients received single daily doses of > >>> Rozerem for up to one > >>> year. Also, based on recently presented clinical trials, Rozerem has been > >>> shown to be safe > >>> for older adults, as well as those who have mild-to-moderate chronic > >>> obstructive > >>> pulmonary disease (COPD) and mild-to-moderate sleep apnea. > >>> > >>> About Insomnia > >>> > >>> Approximately 60 million people in the United States suffer from insomnia, > >>> yet the vast > >>> majority remains undiagnosed and untreated. Insomnia is characterized by > >>> difficulty > >>> falling asleep, difficulty staying asleep, or poor quality sleep, leading > >>> to impairment of > >>> next-day functioning. > >>> > >>> Insomnia has been linked to a variety of health problems, including > >>> obesity, diabetes, > >>> hypertension, heart disease and depression. According to the U.S. Surgeon > >>> General, nearly > >>> $15 billion annually is spent on healthcare related to insomnia, while $50 > >>> billion is lost in > >>> productivity. > >>> > >>> About Rozerem > >>> > >>> Rozerem is indicated for the treatment of insomnia characterized by > >>> difficulty with sleep > >>> onset. Rozerem should not be used in patients with hypersensitivity to > >>> ramelteon or any > >>> components of the formulation. Rozerem can be prescribed for long-term > >>> use. However, > >>> failure of insomnia to remit after a reasonable period of time, worsening > >>> of insomnia, or > >>> the emergence of new cognitive or behavioral abnormalities after taking > >>> Rozerem should > >>> be evaluated, as such symptoms may be the result of an unrecognized > >>> underlying medical > >>> disorder. In primarily depressed patients, worsening of depression, > >>> including suicidal > >>> ideation, has been reported in association with the use of hypnotics. > >>> > >>> Rozerem should not be used by patients with severe hepatic impairment, or > >>> in patients in > >>> combination with fluvoxamine. > >>> > >>> Rozerem has not been studied in subjects with severe sleep apnea or severe > >>> COPD and is > >>> not recommended for use in those populations. Patients should be advised > >>> to exercise > >>> caution if they consume alcohol in combination with Rozerem. > >>> > >>> Rozerem has been associated with decreased testosterone levels and > >>> increased prolactin > >>> levels. As a result, healthcare professionals should be mindful of any > >>> unexplained > >>> symptoms possibly associated with such changes in these hormone levels. > >>> Rozerem has > >>> not been studied in children or adolescents, and the effects in these > >>> populations are > >>> unknown. > >>> > >>> Rozerem should be taken within 30 minutes before going to bed and > >>> activities should be > >>> confined to those necessary to prepare for bed. Rozerem should not be > >>> taken with or > >>> immediately after a high-fat meal. Engaging in hazardous activities that > >>> require > >>> concentration (such as operating a motor vehicle or heavy machinery) after > >>> taking > >>> Rozerem should be avoided. > >>> > >>> The most common adverse events seen with Rozerem that had greater than 2% > >>> incidence > >>> difference from placebo were somnolence, dizziness, and fatigue. > >>> > >>> For more information, please visit the Rozerem website. > >>> > >>> > >>> > >>> > >>> > >>> Opinions expressed are NOT meant to take the place of advice given by > >>> licensed health care professionals. Consult your physician or licensed > >>> health care professional before commencing any medical treatment. > >>> > >>> " Do not let either the medical authorities or the politicians mislead you. > >>> Find out what the facts are, and make your own decisions about how to live > >>> a happy life and how to work for a better world. " - Linus ing, > >>> two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace) > >>> > >>> Quote Link to comment Share on other sites More sharing options...
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