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The sleep-improving effects of doxepin are paralleled by a normalized plasma cortisol secretion in primary insomnia. A placebo-controlled, double-blind, randomized, cross-over study followed by an open treatment over 3 weeks.

Author(s): Rodenbeck A, Cohrs S, Jordan W, Huether G, Ruther E, Hajak G

Affiliation(s): Department of Psychiatry and Psychotherapy, University of Gottingen, Von-Siebold-Strasse 5, 37075 Gottingen, Germany. arodenb@gwdg.de

Publication date & source: 2003-12, Psychopharmacology (Berl)., 170(4):423-8. Epub 2003 Sep 10.

Publication type: Clinical Trial; Randomized Controlled Trial

RATIONALE: In primary care, sedating antidepressants are often used for treating insomnia, although their underlying sleep-promoting mechanisms are only incompletely understood. Since enhanced evening and nocturnal plasma cortisol levels are supposed to maintain insomniac sleep complaints, a functional link between sleep and cortisol secretion in the mode of action of antidepressants in insomnia might be suspected. OBJECTIVES: We therefore investigated the effects of the tricyclic antidepressant doxepin on nocturnal sleep and plasma cortisol concentration in ten patients (age 41.3+/-9.5 years) with chronic primary insomnia between 1700 hours and 0800 hours. METHODS: Single infusions of placebo and 25 mg doxepin were applied following a double-blind, randomized cross-over design. Afterward, all patients received 25 mg doxepin p.o. for 3 weeks in an open-study design. RESULTS: Both doxepin application forms improved sleep significantly and reduced mean cortisol levels from 9.0+/-1.7 microg/l (single placebo i.v.) to 7.5+/-1.6 microg/l (single doxepin i.v.) or 7.6+/-2.0 microg/l (subchronic doxepin p.o.). The duration of the quiescent period of the cortisol rhythm was significantly prolonged following both doxepin administrations compared with placebo. CONCLUSIONS: The results implicate that the sleep-improving effects of doxepin are mediated at least in part by a normalization of hypothalamic-pituitary-adrenal axis functions. Although in some patients rebound insomnia and specific side effects must be considered, our findings give a further rationale for the use of antidepressants in the treatment of primary insomnia.

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