Rozerem - A new sleep medication?

[Guest guest]

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.