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Eszopiclone (Lunesta) With Fluoxetine (Prozac) Improves Comorbid Insomnia in Depression

By Bruce Sylvester

ATLANTA, GA -- May 30, 2005 -- Combination treatment with eszopiclone (Lunesta) and fluoxetine (Prozac) is well tolerated and achieves both rapid and sustained improvements in sleep and daytime symptoms in depressed patients with comorbid insomnia, researchers report.

Lead author Daniel Buysse, MD, Professor of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States, presented the findings here on May 25^th at the American Psychiatric Association (APA) Annual Meeting.

"Eczopiclone effectively treats insomnia associated with major depression, is well tolerated and, very importantly, does not interfere with the antidepressant effect of concurrently administered fluoxetine," Dr. Buysse said.

The investigators enrolled 545 subjects diagnosed with major depression and insomnia according to Diagnostic and Statistical Manual -- Revision IV criteria. For insomnia, patients showed sleep latency of 30 minutes or more (median 74 minutes), wake time after sleep onset of 45 minutes or more (median 90 minutes), and total sleep time of 390 minutes or less (median 294 minutes).

All subjects received fluoxetine 20 mg each morning and were randomized to 8 weeks of double-blind treatment with either eszopiclone 3 mg or placebo daily at bedtime. The researchers assessed subjects weekly for subjective sleep and daytime function data..

Eszopiclone subjects achieved significantly shorter sleep latency and greater total sleep time at each treatment week (P < .03) compared to placebo subjects, and they achieved significantly shorter wake time after sleep onset at weeks 1, 3-5, and 7-8 (P < .04).

Eszopiclone subjects also achieved higher scores for sleep quality and depth throughout the study (P < .005), and higher ratings for daytime alertness, ability to concentrate, and well-being (P +/- .02).

"The rapid sleep improvement with adjunctive eszopiclone may be important, given the relatively slower onset of antidepressant effects with selective serotonin reuptake inhibitors," the authors noted.

Dr. Buysse said, "This is the first study of an insomnia drug conducted in this way and for this population of comorbid patients. It remains to be seen if other drugs of the same class would have the same effect."

The study was supported by Sepracor, Inc.


[Presentation title: Adjunctive Eszopiclone With Fluoxetine for MDD and Insomnia: Sleep Effects. Abstract NR558]

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