The effects of fluoxetine on symptoms of insomnia in depressed patients.

Fluoxetine is an efficacious, nonsedative antidepressant, but its selective efficacy on symptoms of insomnia has not been thoroughly explored. In this analysis, the effects of fluoxetine versus placebo on symptoms of insomnia were evaluated in three clinical subgroups: patients with baseline sleep disturbance, melancholia, or reduced rapid eye movement (REM) latency. Eighty-nine outpatients with major depression completed 2 nights of polysomnography (PSG) and were randomized to fluoxetine or placebo. Within each subgroup of patients, fluoxetine was statistically significantly more effective than placebo in improving non-sleep Hamilton Rating Scale for Depression (HAM-D) items (HAM-D-17 total minus scores from Items 4, 5, and 6). Numerical improvement in HAM-D sleep total (sum of HAM-D Items 4, 5, and 6) was also seen for fluoxetine versus placebo. Fluoxetine did not exacerbate sleep disturbance either at Week 1 or at endpoint. These findings suggest that fluoxetine is an effective antidepressant in patients with baseline sleep disturbance, melancholia, and reduced REM latency.