Guest guest Posted May 8, 2005 Report Share Posted May 8, 2005 LUNESTA™ Now Widely Available by Prescription to Treat Insomnia; Estimated 100 Million Americans Suffer From Insomnia MARLBOROUGH, Mass., April 7 /PRNewswire-FirstCall/ -- Sepracor Inc. today announced that LUNESTA (eszopiclone 1 mg, 2 mg and 3 mg tablets) is now available by prescription in most pharmacies nationwide. LUNESTA is the first and only sleep aid (prescription or over-the-counter), which has been approved by the U.S. Food and Drug Administration (FDA) for long-term treatment of insomnia. LUNESTA is the first treatment in its class that has been shown to not only help patients fall asleep quickly, but also sleep all through the night. " LUNESTA is a new prescription, non-narcotic sleep aid approved to treat insomnia and, unlike other sleep aids, is approved for long-term use, " said Winkelman, M.D., Ph.D., Associate Director for the Sleep Disorders Program at Brigham and Women's Hospital, Boston. " LUNESTA is an important treatment option for the millions of people who have the ongoing problem of not getting a good night's sleep. " LUNESTA is approved as a prescription, non-narcotic sleep aid to treat insomnia. Insomnia symptoms can include difficulty falling asleep and/or not sleeping all through the night. LUNESTA has been studied in patients for up to 12 months and in more than 30 clinical trials enrolling more than 4,700 patients. " I am extremely pleased that millions of patients who have trouble sleeping, whether it be on a short- or long-term basis, have an effective new prescription treatment option available in their local pharmacy, " continued Winkelman. " I expect that LUNESTA, with its approval for long-term use and effectiveness in helping people stay asleep through the night, will allow most people who suffer from insomnia to get a refreshing night of sleep without feeling groggy the next day. " About Insomnia Insomnia can include difficulty falling asleep as well as difficulty maintaining sleep through the night. An estimated 100 million adult Americans suffer from either chronic or occasional insomnia.(1) Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed. Insomnia can be a serious condition. If left untreated, it may become progressively worse and in turn, potentially affect a person's emotional, mental and physical health. Important Safety Information LUNESTA should only be taken immediately before bedtime. Be sure you have at least eight hours to devote to sleep before becoming active. You should not engage in any activity after taking LUNESTA that requires complete alertness, such as driving a car or operating machinery. You should use extreme care when engaging in these activities the morning after taking LUNESTA. Do not use alcohol while taking any sleep medicine. All sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods without first talking to your doctor. Side effects may include unpleasant taste, headache, drowsiness and dizziness. Please visit http://www.sepracor.com/ or http://www.lunesta.com/ to access the FDA-approved labeling text for LUNESTA. About Sepracor Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded an extensive portfolio of pharmaceutical compound candidates with a focus on respiratory and central nervous system disorders. The company's commercialization efforts are carried out by its U.S.-based, 1,250-person, primary care and specialty-oriented sales force. Sepracor's corporate headquarters are located in Marlborough, Massachusetts. This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the availability and commercial launch of LUNESTA brand eszopiclone, as well as the safety, efficacy and potential benefits of LUNESTA. Among the factors that could cause actual results to differ materially from those indicated by such forward- looking statements are: unexpected interruptions in commercial distribution of LUNESTA; Sepracor's ability to fund, and the results of, further clinical trials; the timing and success of submission, acceptance and approval of additional regulatory filings; the scope of Sepracor's patents and the patents of others; the commercial success of LUNESTA; the ability of the company to attract and retain qualified personnel; and certain other factors that are detailed in the company's annual report on Form 10-K for the year ended December 31, 2004 filed with the Securities and Exchange Commission. In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release. LUNESTA is a trademark of Sepracor Inc. (1) Extrapolated to current population from 2000 census based on Ancoli- Israel et al. SLEEP. 1999;22 (suppl 2):S347-S353. CONTACT: P. Southwell, Executive Vice President and Chief Financial Officer, or Jonae R. , Vice President, Investor Relations, +1-508-481- 6700, both of Sepracor Inc. Web site: http://www.sepracor.com/ Quote Link to comment Share on other sites More sharing options...
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