Drug improves insomnia in patients with GAD

Sepracor Inc. recently announced the presentation of results from a Phase IV, 595-patient, double-blind, placebo-controlled, ten-week study evaluating the efficacy and safety of Lunesta® brand eszopiclone in patients with insomnia and co-existing generalized anxiety disorder (GAD). The results were presented last week at the annual meeting of the American College of Neuropsychopharmacology in Hollywood, FL.

In the study, patients who met DSM-IV criteria for both insomnia and GAD were randomized to receive nightly doses of Lexapro® brand escitalopram oxalate 10mg, which is approved to treat GAD, and either Lunesta 3mg or placebo for the first eight weeks, followed by a two-week period in which patients discontinued study drug but continued receiving escitalopram and placebo.

The researchers assessed sleep efficacy using patient-reported measures of sleep onset, total sleep time (TST), and wake up time after sleep onset (WASO) – a sleep maintenance measurement of the amount of time spent awake after initially falling asleep. Symptoms of GAD were assessed using the clinician-rated HAM-A scale (Hamilton Anxiety Rating Scale). Study completion rates were about 78% in both the placebo-escitalopram and Lunesta-escitalopram treatment groups.

Since depression and anxiety frequently co-exist, symptoms of depression were also evaluated using the HAM-D17 (Hamilton Depression Rating Scale) throughout the study. The HAM-D17 is a standard scale used in assessing depression in clinical studies and consists of a list of symptoms commonly linked to depression.

Compared to patients in the placebo-escitalopram group, patients in the Lunesta-escitalopram group showed significant improvements from in sleep onset, TST, WASO and number of awakenings, during each assessment week and when averaged over the 8-week, double-blind treatment period.

The Lunesta-escitalopram group demonstrated reductions from baseline in HAM-A and HAM-D17 scores that were statistically significantly greater than those in the placebo group during each assessment week of the 8-week period. Lunesta was well-tolerated over the treatment duration.

“Patients suffering from insomnia frequently have co-existing physical and psychiatric illnesses,” said Mark H.N. Corrigan, MD, Executive Vice President, Research and Development at Sepracor. “Studies indicate that approximately 10% of the adult population suffers from chronic insomnia and that in approximately 80% of these patients, insomnia co-exists with other psychiatric and medical illnesses. Sepracor continues to study the effect of the treatment of insomnia with Lunesta in patients with a co-existing disease or condition. To date, our Phase IV program has examined how Lunesta can effectively treat insomnia in patients with co-existing depression, pain, menopause, and now anxiety,” he continued.

It’s estimated that 36% of adults in the US have reported suffering from either chronic or occasional insomnia in the last year. Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking too early, being unable to fall back to sleep, or awakening feeling unrefreshed.

© Copyright 2007 Insight Journal Online Magazine.

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