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LUNESTA(R) Study of Patients with Insomnia and Co-Morbid

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surf1944   Tuesday, 05/13/08 03:19:25 PM
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LUNESTA(R) Study of Patients with Insomnia and Co-Morbid Generalized Anxiety Disorder (GAD) Published in Archives of General Psychiatry
Monday May 12, 7:00 am ET
-- Study is first published, large-scale, double-blind randomized trial examining use of insomnia and anxiety treatments in patients with co-morbid insomnia and GAD
-- Co-administration of LUNESTA(R) brand eszopiclone and anti-anxiety agent associated with significantly improved measures of sleep, daytime functioning, anxiety and mood
-- At least two-thirds of patients with GAD also have at least one symptom of co-morbid insomnia

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sepracor Inc. (Nasdaq: SEPR - News) 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®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≤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.

surf's up......crikey

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