Efficacy and Safety of Doxepin 1 mg, 3 mg, and 6 mg in Elderly Patients With Primary Insomnia

作者：Martin B. Scharf, Roberta Rogowski, Steven Hull, Martin A. Cohn, David Mayleben, Neil T. Feldman, Larry Ereshefsky, Alan Lankford, Thomas Roth · 发表于：The Journal of Clinical Psychiatry · 年份：2008 · DOI：10.4088/jcp.v69n1005 · 被引用次数：111 · 研究领域：Sleep and related disorders、Sleep and Wakefulness Research、Sleep and Work-Related Fatigue

OBJECTIVES: Evaluate efficacy and safety of the histamine-H1 antagonist doxepin at doses of 1 mg, 3 mg, and 6 mg in elderly adults with primary insomnia. DESIGN: A randomized, double-blind, placebo-controlled, crossover design was used in this population of elderly adults with primary insomnia (DSM-IV). Each treatment period consisted of 2 polysomnographic (PSG) assessment nights with a 5- or 12-day drug-free interval between periods. The study was conducted from September 2004 to January 2005. SETTING: Sleep laboratories in 11 sleep centers in the United States. PARTICIPANTS: Elderly adults with primary insomnia. INTERVENTION: Doxepin 1 mg, 3 mg, and 6 mg. MEASUREMENTS: Efficacy was assessed using PSG and patient-reported measures. RESULTS: Seventy-six patients were randomly assigned. All 3 doxepin doses produced dose-related significant improvements in PSG-determined wake time during sleep (p < .0001), wake time after sleep onset (p < .0001), total sleep time (p < .0001), and overall sleep efficiency (p < .0001) versus placebo. At the 3-mg and 6-mg doses, sleep efficiency was significantly improved during all thirds of the night (p < .05). There was a dose-related decrease in patient-reported sleep latency, with the 6-mg dose achieving statistical significance in latency to sleep onset (p = .0181). The pattern of the remaining subjective efficacy results was consistent with PSG. All 3 doxepin doses had side effect profiles comparable to placebo, with no spontaneously report...