Lunesta Data Presented at 2005 American Psychiatric Association Meeting Poster Session
Two LUNESTA posters reported the findings of a study in patients with co-existing insomnia and depression. Insomnia symptoms are reported in 65 percent to 90 percent of individuals with depression.1 An additional poster presented data on LUNESTA's effect on sleep parameters that impact next-day function, and the results of a crossover study evaluating the safety and efficacy of LUNESTA versus placebo were also presented.
Adjunctive Eszopiclone With Fluoxetine for Major Depressive Disorder (MDD) and Insomnia: Sleep Effects
The results of a Phase IIIB/IV, 545-patient, double-blind, placebo-controlled, ten-week study evaluating the efficacy and safety of eszopiclone in patients with major depressive disorder (MDD) and insomnia were presented. In this study, patients who met DSM-IV2 criteria for both insomnia and MDD (either newly diagnosed or patients who have relapsed), were randomized to receive open-label PROZAC(R) brand fluoxetine each morning and either double-blind eszopiclone 3 mg (n=270) or placebo (n=275) nightly for the first eight weeks, followed by a two-week period during which patients discontinued double-blind treatment but continued receiving fluoxetine.
In this study, patient-reported sleep and daytime function measures were assessed. Sleep efficacy was determined using patient-reported measures of time to sleep onset, wake time after sleep onset (WASO; a sleep maintenance measurement of the amount of time spent awake after initially falling asleep and the primary endpoint in this analysis) and total sleep time (TST). Sleep quality and depth, sense of physical well-being, daytime alertness, ability to function and ability to concentrate were also measured.
Averaged over the double-blind period, patients treated with eszopiclone showed statistically significant (p
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