LOw-Dose doxepin for Insomnia

Abstract

A tricyclic antidepressant first approved in 1969, doxepin has long been available in larger doses (10-, 25-, 50-, 75-, 100-, and 150-mg capsules) to treat depression and anxiety and as a topical preparation (5 % cream) for pruritus, but not in dosages <10 mg. Low-dose doxepin—3 and 6 mg—has demonstrated efficacy for insomnia characterized by frequent or early morning awakenings and an inability to return to sleep. FDA-approved in March 2010, doxepin (3 and 6 mg) is only the second insomnia medication not designated as a controlled substance and thus may be of special value in patients with sleep maintenance insomnia with a history of substance use disorders.