Abstract | 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: INTERVENTION: 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 reported anticholinergic effects, no memory impairment, and no significant next-day residual effects. CONCLUSIONS: In this 2-night study of elderly adults with primary insomnia, doxepin doses of 1 mg, 3 mg, and 6 mg were well tolerated and produced significant improvement in objective and subjective sleep maintenance and duration endpoints that persisted into the final hour of the night. Positive effects on patient-reported sleep onset were observed at the highest dose. All 3 doxepin doses had a safety profile comparable to placebo. These data demonstrate that doxepin was efficacious in improving sleep in elderly adults.
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Authors | Martin Scharf, Roberta Rogowski, Steven Hull, Martin Cohn, David Mayleben, Neil Feldman, Larry Ereshefsky, Alan Lankford, Thomas Roth |
Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 69
Issue 10
Pg. 1557-64
(Oct 2008)
ISSN: 1555-2101 [Electronic] United States |
PMID | 19192438
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2008 Physicians Postgraduate Press, Inc. |
Chemical References |
- Histamine Antagonists
- Doxepin
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Topics |
- Aged
- Cross-Over Studies
- Dose-Response Relationship, Drug
- Double-Blind Method
- Doxepin
(administration & dosage, adverse effects, pharmacology)
- Drug-Related Side Effects and Adverse Reactions
- Female
- Histamine Antagonists
(administration & dosage, adverse effects, pharmacology)
- Humans
- Male
- Polysomnography
- Sleep Initiation and Maintenance Disorders
(drug therapy)
- Sleep Stages
(drug effects)
- United States
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