February 21, 2007
Sepracor Inc, Marlborough, Mass, today announced that additional data from its Phase IIIB/IV, 545-patient study of LUNESTA® brand eszopiclone in patients with insomnia and co-existing major depressive disorder (MDD) have been published in the February 2007 edition of the Journal of Clinical Sleep Medicine. This manuscript contains results from the 2-week, single-blind, placebo run-out period of the study that evaluated hypnotic discontinuation effects following an 8-week, placebo-controlled study of LUNESTA and PROZAC® brand fluoxetine co-therapy in patients with insomnia and co-existing MDD.
The study endpoints contained in the Journal of Clinical Sleep Medicine manuscript were the evaluation of withdrawal effects during the 2-week discontinuation period, which is also referred to as the run-out period, by examining: 1) the prevalence of new or worsening CNS (central nervous system)-related adverse events, 2) rebound insomnia, and 3) worsening of MDD symptoms. The rebound insomnia variables were assessed using an interactive voice-response system (IVRS) during the run-out period and they included sleep onset, wake time after sleep onset (WASO), total sleep time (TST), and measures of daytime functioning.
In this study, patients discontinued from LUNESTA maintained improvements from baseline in sleep onset, WASO, and TST during the 2-week discontinuation period (p less than 0.05). LUNESTA discontinuation did not result in significant CNS withdrawal adverse events, rebound insomnia or rebound depression, and improvements in sleep and depressive symptoms were maintained. The improvements in the HAM-D17 scale scores with and without the three sleep items observed with co-therapy versus monotherapy at Week 8 (p less than 0.02) were maintained at Week 10 (p less than 0.002) in the group initially randomized to co-therapy.
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