Clinical impact of duloxetine treatment on sleep in patients with major depressive disorder.

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 (HAMD(17)) 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 HAMD(17) 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 HAMD(17) sleep subscale compared with placebo-treated patients (mean=-1.2 vs. -1.1, P< or =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< or =0.001), middle insomnia (1.4 vs. 0.3%, P=0.001), and hypersomnia (1.0 vs. 0.3%, P< or =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.