In this study, perimenopausal or early menopausal women experiencing insomnia according to DSM-IV®(1) criteria were randomized to LUNESTA 3 mg or matching placebo nightly for four weeks. This four-week, double-blind treatment period was followed by a one-week discontinuation phase during which all patients received single-blind placebo. Patients treated with LUNESTA demonstrated statistically significant improvement (p<0.01) compared with placebo in patient-reported measures of sleep latency (onset of sleep), wake time after sleep onset (WASO; a sleep maintenance measurement of the amount of time spent awake after initially falling asleep) and total sleep time for each week of the study. Secondary measures of sleep quality, depth of sleep, daytime alertness, ability to function, ability to concentrate and physical well-being were also statistically significantly (p<0.05) improved over the double-blind period for patients administered LUNESTA versus those administered placebo. Additionally, insomnia severity index-assessed sleep quality, feeling refreshed/rested, daytime fatigue, attention/concentration, and mood disturbance parameters were statistically significantly (p<0.05) improved with LUNESTA compared with placebo. There was no evidence of rebound insomnia or other withdrawal phenomena during the discontinuation phase in the patients who had received 28 days of nightly dosing with LUNESTA 3 mg.
Measures of other menopausal symptoms, including mood, quality of life, and impairment in daily activities were also assessed in this study using the Greene Climacteric Scale (GCS), Montgomery Asberg Depression Rating Scale, the Menopause Quality of Life questionnaire (MENQoL), the Sheehan Disability Scale (SDS), as well as the physician global assessment of menopausal symptoms. As compared with placebo, patients administered LUNESTA after 4 weeks demonstrated a statistically significantly (p<0.05) greater reduction from baseline in nighttime awakenings due to hot flashes and a significant improvement in mood as measured by the Montgomery Asberg Depression Rating Scale. Statistically significantly (p<0.05) greater changes from baseline were noted with LUNESTA on the GCS (total score, psychological and vasomotor domains), MENQoL (vasomotor and physical domains), and the SDS (family/home domain). A physician global assessment, which evaluated the overall improvement in menopausal symptoms at the end of the four-week period, demonstrated that more patients (p<0.001) administered LUNESTA were "very much improved" or "much improved" in menopausal symptoms versus those patients administered placebo. No significant difference was observed between treatment groups in number or severity of daytime hot flashes at each week or over the four-week treatment period. LUNESTA was well tolerated in the study.
"More than 1.3 million women become menopausal each year in the U.S., adding to the existing 40 million American women of menopausal age who are already going through various neuroendocrine and somatic changes. Those changes may frequently be accompanied by symptoms of insomnia such as waking up during the night and difficulty falling back to sleep, particularly in the presence of hot flashes," said Claudio N. Soares, M.D., Ph.D., Associate Professor, Department of Psychiatry and Behavioral Neurosciences, McMaster University and Director, Women's Health Concerns Clinic at St. Joseph's Healthcare, Hamilton, Canada. "This study of LUNESTA in women experiencing perimenopausal symptoms suggests that LUNESTA may provide them with relief from insomnia and therefore could lead to a significant improvement in their quality of life."
To access the study published in the Journal of Obstetrics and Gynecology, please visit: http://www.greenjournal.org/cgi/reprint/108/6/1402. Sepracor assumes no responsibility for the information or statements found on this site and such information and statements are not incorporated by reference into this press release.
Perimenopause in women is the transition period from normal reproductive function to complete cessation of the menstrual period, or menopause. During this transition, which can be years in duration, and continuing through to the post-menopausal period, the body experiences both physical and hormonal changes, which can be associated with a variety of symptoms. Problems sleeping and the resulting fatigue may occur due to waking up in the middle of the night because of hot flashes or the need to go to the bathroom, which can lead to trouble falling back to sleep. During this time, women may also experience trouble falling to sleep or waking up early in the morning. According to the Agency for Healthcare Research and Quality, up to 40 to 60 percent of perimenopausal, menopausal, and post-menopausal women experience sleep disturbances.
An estimated 36 percent of adult Americans reported suffering from either chronic or occasional insomnia in the last year.(2) 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.
About LUNESTA
LUNESTA is indicated for the treatment of insomnia in patients 18 years of age and older who are experiencing difficulty falling asleep and/or maintaining sleep through the night. LUNESTA is not indicated as a treatment for any other medical or psychiatric disorder. LUNESTA is available in 1 mg, 2 mg and 3 mg tablets and treatment should be individualized based on patient age, history and insomnia symptoms. LUNESTA is a Schedule IV controlled substance.
Important Safety Information
LUNESTA is indicated for the treatment of insomnia. LUNESTA is not indicated for the treatment of perimenopause or menopause. LUNESTA works quickly and should only be taken immediately before bedtime. Patients should have at least eight hours to devote to sleep before becoming active. Patients should not engage in any activity after taking LUNESTA that requires complete alertness, such as driving a car or operating machinery. Patients should use extreme care when engaging in these activities the morning after taking LUNESTA. Patients should not use alcohol while taking any sleep medicine. Most sleep medicines carry some risk of dependency. Patients should not use sleep medicines for extended periods without first talking to their doctor. Patients should see their doctor if they experience unusual changes in thinking or behavior, or sleep problems do not improve in 7 to 10 days as this may be due to another medical condition. Side effects may include unpleasant taste, headache, drowsiness and dizziness.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
Forward-Looking Statement
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and potential benefits of LUNESTA brand eszopiclone. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: 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; any changes in the use and/or label of LUNESTA; the ability of the company to attract and retain qualified personnel; and certain other factors that are detailed in the company's quarterly report on Form 10-Q for the quarter ended September 30, 2006 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.
(1) Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition
(2) Ancoli-Israel et al. SLEEP. 1999;22 (suppl 2):S347-S353
LUNESTA is a registered trademark of Sepracor Inc. DSM-IV is a registered trademark of the American Psychiatric Association.
For a copy of this release or any recent release, visit
www.sepracor.com.
Contact: Sepracor Inc. David P. Southwell, 508-481-6700 Chief Financial Officer or
Jonae R. Barnes, 508-481-6700 Vice President Investor Relations
Source: Sepracor Inc.
