Lunesta Study of Patients with Insomnia and Co-Morbid Generalized Anxiety Disorder (GAD) Published in Archives of General PsychiatryMARLBOROUGH, Mass.--(BUSINESS WIRE)--May 12, 2008 - Sepracor Inc. (Nasdaq: SEPR) today announced the publication of a study of LUNESTA tablets in patients with insomnia and co-morbid generalized anxiety disorder (GAD) in the May issue of the Archives of General Psychiatry. This 595-patient study examined the safety and efficacy of LUNESTA co-administered with escitalopram oxalate, which is commonly used in the treatment of anxiety, versus co-administration of escitalopram and placebo in patients with insomnia and co-existing GAD. The study also evaluated the potential for co-administration of LUNESTA to increase the magnitude and/or accelerate the anxiolytic response versus escitalopram alone.
"Patients suffering from insomnia may have co-existing medical and psychiatric illnesses," said Mark H.N. Corrigan, M.D., Executive Vice President, Research and Development at Sepracor. "In fact, studies indicate that approximately ten percent of the adult population suffers from chronic insomnia, and that in approximately 80 percent of these patients, insomnia co-exists with other psychiatric and medical illnesses. The results of this study are consistent with results of other studies of LUNESTA evaluating insomnia with major depressive disorder and symptoms associated with perimenopause, which have shown that improvements in sleep can have positive effects on the co-morbid condition."
"To my knowledge, this is the first large-scale, double-blind, randomized clinical trial published that assessed the use of an insomnia treatment in conjunction with a selective serotonin reuptake inhibitor, or SSRI, in the treatment of patients with insomnia and co-morbid GAD," said W. Vaughn McCall, M.D., Professor and Chairman of the Department of Psychiatry and Behavioral Medicine at the Wake Forest University School of Medicine. "In this study, patients with insomnia and co-morbid GAD who took LUNESTA and escitalopram co-therapy showed improvements in measures of sleep and anxiety. Given the high incidence of insomnia symptoms co-existing with GAD, and the results seen in this clinical trial, I believe that further study of insomnia and its relationship to GAD is warranted."
In this multicenter, randomized, double-blind, placebo-controlled, parallel-group study, patients 18 to 64 years of age who met DSM-IV-TR(R)(1) criteria for insomnia and GAD were administered 10 mg of escitalopram nightly, plus either placebo or LUNESTA 3 mg nightly for eight weeks. The eight weeks of double-blind treatment were followed by a two-week run-out period in which all patients were administered escitalopram and placebo to evaluate the potential for rebound insomnia and withdrawal effects associated with LUNESTA discontinuation.
Patients treated with LUNESTA and escitalopram co-therapy demonstrated significant (p<0.001) improvement in all measured sleep parameters when averaged over the eight-week, double-blind period, including the primary endpoint of sleep latency (25-minute decrease in sleep onset), sleep maintenance and total sleep time (TST; 60-minute increase), compared with patients who were treated with escitalopram and placebo (11.5-minute decrease for sleep onset and 35-minute increase for TST). LUNESTA-escitalopram co-therapy also resulted in significant (p< or =0.007) patient-reported improvements from baseline in daytime symptoms of insomnia, including daytime alertness, ability to function, ability to concentrate and physical well-being compared to escitalopram-placebo administration when averaged over the treatment period. Consistent with other published studies of LUNESTA, there was no evidence of tolerance (diminution of effect over time), rebound insomnia or serious withdrawal syndrome following discontinuation from this study.
When evaluating anxiolytic effects of the two treatment arms, patients administered LUNESTA and escitalopram co-therapy demonstrated significant (p<0.05) improvements from baseline in total HAM-A (Hamilton Anxiety Rating Scale, a standard scale used to assess anxiety in clinical trials and consisting of a list of symptoms commonly associated with anxiety, including insomnia) scores for each week of the study. CGI-I (Clinical Global Impression of Improvement, a scale that captures physicians' ratings of patients' mental illness symptoms) scores were significantly (p<0.02) improved in the LUNESTA-escitalopram treatment group at each time point versus the placebo-escitalopram group. CGI-S (Clinical Global Impression of Severity) scores were not significantly different after Week 1.
Since anxiety and depression can co-exist, symptoms of depression were also evaluated using the clinician-rated HAM-D17 (Hamilton Depression Rating Scale) throughout the study. The Hamilton Depression Rating Scale is a standard scale used to assess depression in clinical trials and consists of a list of symptoms commonly associated with depression (including insomnia).
The LUNESTA-escitalopram group demonstrated reductions from baseline in HAM-D17 scores that were statistically significantly greater (p<0.05) than those seen in the placebo-escitalopram group at each week of the eight-week, double-blind treatment period. In this study, LUNESTA and escitalopram were generally well tolerated.
This publication can be accessed on the Archives of General Psychiatry web site at www.archgenpsychiatry.com.
Approximately ten percent of adults in the U.S. suffer from chronic insomnia, symptoms of which include difficulty falling asleep, awakening frequently during the night and/or waking up too early with an inability to fall back to sleep, resulting in patients feeling unrefreshed.
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 anxiety, depression or any other medical or psychiatric disorder other than insomnia. 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.
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. As with all sleep medicines, somnambulism (sleepwalking), including eating or driving while not fully awake, with amnesia for the event, has been reported. Additionally, rare cases of severe allergic reactions have been reported. Patients who report these events should discontinue treatment and should not be rechallenged with LUNESTA. 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 if 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.
LUNESTA, like other sleep medicines, may produce additive CNS-depressant effects when co-administered with other psychotropic medications, anticonvulsants, antihistamines, ethanol, and other drugs that themselves produce CNS depression. Dosage adjustment may be necessary when LUNESTA is administered with other CNS-depressant agents because of the potentially additive effects. In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides) have been reported in association with the use of sleep medicines; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.
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 large and growing markets and 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. Currently marketed products include LUNESTA(R) brand eszopiclone, XOPENEX(R) brand levalbuterol HCl Inhalation Solution, XOPENEX HFA(R) brand levalbuterol tartrate Inhalation Aerosol, BROVANA(R) brand arformoterol tartrate Inhalation Solution and OMNARIS(TM) brand ciclesonide Nasal Spray. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
(1) Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition- Text Revision
LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks of Sepracor Inc. DSM-IV-TR is a registered trademark of the American Psychiatric Association. OMNARIS is a trademark of Nycomed GmbH. For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com.
David P. Southwell, 508-481-6700
Chief Financial Officer
Jonae R. Barnes, 508-481-6700
Sr. Vice President
Posted: May 2008