ORIGINAL ARTICLESClinical impact of duloxetine treatment on sleep in patients with major depressive disorderBrecht, Stephana; Kajdasz, Danielb; Ball, Susanb; Thase, Michael E.cAuthor Information aBoehringer Ingelheim GmbH, Ingelheim, Germany bLilly Research Laboratories, Indianapolis, Indiana cUniversity of Pennsylvania School of Medicine, Philadelphia Veterans Affairs Medical Center, and University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA Correspondence to Stephan Brecht, MD, PhD, Boehringer Ingelheim GmbH, Binger Str. 173, 55216 Ingelheim, Germany Tel: +49 6132 773342; fax: +49 6132 723342; e-mail: [email protected] Received 19 December 2007 Accepted 28 April 2008 International Clinical Psychopharmacology: November 2008 - Volume 23 - Issue 6 - p 317-324 doi: 10.1097/YIC.0b013e328306a987 Buy Metrics Abstract The objective of this study was to conduct a meta-analysis of the clinical impact of duloxetine treatment on sleep in adults with major depressive disorder. Data were pooled from 11 placebo-controlled, double-blind studies of duloxetine treatment (8–9 weeks acute therapy, modal dose 60 mg/day). Sleep outcome was assessed by the Hamilton Depression Rating Scale-17 (HAMD17) sleep items (onset latency, middle awakening, and early awakening) and their sum (insomnia subscale) and by occurrence of sleep-related treatment-emergent adverse events (TEAEs). Efficacy was measured by HAMD17 Maier subscale scores. Adult outpatients (mean age: 45.4 years; 65.8% women) were assigned randomly to duloxetine (N=1760) or placebo (N=1159). Duloxetine-treated patients improved more on the HAMD17 sleep subscale compared with placebo-treated patients (mean=−1.2 vs. −1.1, P≤0.05). Sleep-related TEAEs that occurred more frequently for patients treated with duloxetine, compared with placebo, were insomnia (8.9 vs. 5.9%, P≤0.001), middle insomnia (1.4 vs. 0.3%, P=0.001), and hypersomnia (1.0 vs. 0.3%, P≤0.01). Patients with sleep-related TEAEs demonstrated similar mean improvement in Maier subscale score as patients without sleep-related TEAEs (P=0.223). Compared with placebo, duloxetine treatment was associated with a positive, but negligible, benefit on clinical ratings of insomnia and with more frequent sleep-related TEAEs that did not negatively impact overall efficacy for major depressive disorder. © 2008 Lippincott Williams & Wilkins, Inc.