Doxepin in the Treatment of Primary Insomnia: A Placebo-Controlled, Double-Blind, Polysomnographic Study
J Clin Psychiatry 2001;62(6):453-463
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: Over recent years, the use of
antidepressants for the symptomatic treatment of insomnia has
grown substantially, but controlled studies are still lacking.
Our study is the first investigation to prove objective efficacy
and tolerability of low doses of a sedating antidepressant in a
randomized, double-blind, and placebo-controlled manner in
patients with primary insomnia.
Method: Forty-seven drug-free patients meeting
DSM-IV criteria for primary insomnia (mean ± SD duration of
complaints = 11.2 ± 9.7 years) received either 25-50 mg of the
tricyclic antidepressant doxepin or placebo for 4 weeks followed
by 2 weeks of placebo withdrawal. Sleep was measured by
polysomnography at baseline and the first night of application,
at 4 weeks of treatment and the first to third night of
withdrawal, and after 2 weeks of withdrawal.
Results: In the doxepin-treated patients who
completed the study (N = 20, 47.6 ± 11.3), medication
significantly increased sleep efficiency after acute (night 1, p
<= .001) and subchronic (night 28, p <= .05) intake
compared with the patients who received placebo (N = 20, 47.4 ±
16.8 years of age). Latency to sleep onset was not affected since
the patients had normal baseline sleep latencies. Investigators
found doxepin to cause significantly (p <= .05) better global
improvement at the first day of treatment. Patients rated sleep
quality (p <= .001) and working ability (p <= .005) to be
significantly improved by doxepin during the whole treatment
period. Overall rebound in sleep parameters was not observed, but
patients with severe rebound insomnia were significantly more
frequent in the doxepin group (night 29, p <= .01; night 30, p
<= .01; night 31, p <= .05). No significant group
differences in side effects were found, but 2 doxepin-treated
patients dropped out of the study due to specific side effects
(increased liver enzymes, leukopenia, and thrombopenia).
Conclusion: The results support the
effectiveness of low doses of doxepin to improve sleep and
working ability in chronic primary insomniacs, although
subjective effects were light to moderate, and in some patients,
rebound insomnia and specific side effects have to be considered.