Doxepin for Sleep Maintenance Insomnia

Excerpt from BMJ Clinical Review article:

“Doxepin is a selective histamine receptor antagonist (fig 3⇑).130 At doses above 25 mg, doxepin has unpleasant anticholinergic and antiadrenergic side effects, but at doses of 6 mg or less its predominant mechanism of action is blockade of the wake promoting effects of histamine through histamine H1 receptor antagonism.130 Low dose doxepin (3 mg or 6 mg) improves sleep maintenance insomnia, and its safety and efficacy have been evaluated in a double blind placebo controlled trial in adults of all ages with chronic insomnia.129 130 131 In a randomized, double blind, parallel group, placebo controlled trial, 221 patients with insomnia were randomized to 35 days of doxepin at 3 mg (n=75) or 6 mg (n=73), or to placebo (n=73); efficacy data were assessed at nights 1, 15, and 29.129 Compared with placebo, both doses of doxepin significantly improved WASO on night 1 (P<0.0001), night 15 (3 mg: P=0.0025; 6 mg: P=0.0009), and night 29 (3 mg: P=0.0248; 6 mg: P=0.00), latency to persistent sleep (3 mg: P=0.0047; 6 mg: P=0.0007), and TST subjectively and objectively (night 1, 3 mg and 6 mg: P<0.0001; night 15, 6 mg: P=0.0035; night 29, 3 mg: P=0.0261, 6 mg: P<0.0001) without causing rebound insomnia when discontinued.”


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