The Medical Letter on Drugs and Therapeutics
Low-Dose Doxepin (Silenor) for Insomnia
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The FDA has approved a new low-dose formulation of the tricyclic antidepressant doxepin (Silenor – Somaxon) for treatment of insomnia associated with sleep maintenance. The manufacturer claims that this dose retains the hypnotic effect of doxepin, without typical tricyclic adverse effects. Doxepin is available generically in higher-strength capsules and in a liquid formulation.

MECHANISM OF ACTION — The usual dosage of doxepin for treatment of depression is 75-150 mg/day. At this dose, doxepin has antihistaminic and anticholinergic effects. Its affinity for H1-receptors, which is thought to be largely responsible for its sedating effect, is greater than its affinity for other receptors.1

CLINICAL STUDIES — In a double-blind trial, 565 healthy volunteers without insomnia were randomized to doxepin 6 mg or placebo. Efficacy was measured by ... more      

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Title: Low-Dose Doxepin (Silenor) for Insomnia
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