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www.fdanews.com/articles/67650-preliminary-results-show-improvement-for-insomnia-patients-with-co-existing-depression-who-were-treated-with-lunesta

PRELIMINARY RESULTS SHOW IMPROVEMENT FOR INSOMNIA PATIENTS WITH CO-EXISTING DEPRESSION WHO WERE TREATED WITH LUNESTA

January 17, 2005

Sepracor has announced the preliminary results of a Phase IIIb/IV, 545-patient, double-blind, placebo-controlled, 10-week study evaluating the efficacy and safety of Lunesta brand eszopiclone in patients with insomnia and co-existing major depressive disorder (MDD).

In this study, patients who met criteria for both insomnia and MDD (either newly diagnosed or patients who have relapsed), were randomized to receive nightly Prozac brand fluoxetine and either eszopiclone 3 mg or placebo for the first eight weeks, followed by a two-week period in which patients discontinued eszopiclone treatment but continued receiving fluoxetine.

Averaged over the double-blind period, patients treated with eszopiclone showed statistically significant improvements in time to sleep onset and in sleep maintenance measures, compared to those subjects taking placebo.