Abstract
Nefazodone is a new antidepressant drug that is both a 5-HT2 antagonist and a serotonin reuptake inhibitor. It has been demonstrated to be safe and effective for the treatment of patients with major depression.
This double-blind, randomized, parallel group study compared the effects of nefazodone and placebo on sleep architecture and daytime alertness in 22 normal volunteers. Polysomnographic recordings were obtained in the sleep laboratory for each subject (11 per treatment group) during a 3-night placebo run-in period, 8 nights of a 2-week treatment period, and 2 nights of placebo washout. Nightly time in bed was controlled at 480 minutes for all subjects. Following the single-blind placebo run-in period, subjects were randomized to receive either nefazodone or placebo. Nefazodone was dosed at 100 mg BID during the first treatment week and 200 mg BID during the second week. Daytime alertness was evaluated using the Multiple Sleep Latency Test (MSLT) before, during, and after treatment.
Compared with placebo, nefazodone did not disrupt normal sleep architecture and, unlike most other antidepressant drugs, it had no effect on REM sleep (time, density, or latency). Although nefazodone is mildly sedating clinically, it had no overall effect on total sleep time (or sleep efficiency) or the number of awakenings. In addition, all other aspects of sleep architecture, including the proportion of slow wave (stage 3 and 4) sleep, were unchanged after two weeks of treatment. The MSLT showed no evidence that nefazodone caused daytime sleepiness.
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Vogel, G., Cohen, J., Frescura, M. et al. Effects Of Nefazodone On Sleep Architecture And Daytime Alertness. Neuropsychopharmacol 11, 288 (1994). https://doi.org/10.1038/sj.npp.1380227
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DOI: https://doi.org/10.1038/sj.npp.1380227