Efficacy and safety of low-dose doxepin in depressed patients suffering from insomnia: a retrospective, naturalistic case series analysis.

Low-dose doxepin has produced favorable results in healthy adults and elderly persons with chronic or transient insomnia, while exhibiting an amenable adverse event profile. The aim of this article is to investigate the efficacy and safety of low-dose doxepin for insomnia in depressed patients.In this retrospective case series analysis, the files of 17 inpatients diagnosed with major depressive disorder (MDD) and comorbid insomnia between January 1, 2011, and October 1, 2012 who had received a course of off-label doxepin (< 25 mg/d) were analyzed with regard to dose, efficacy, and safety for up to 4 weeks of treatment. Hamilton Depression Rating Scale (HDRS) sleep item scores were used to estimate efficacy.Our results showed no improvement in sleep onset and sleep maintenance insomnia in patients with MDD during the 4 weeks of treatment. We found a significant improvement in insomnia between baseline and week 3 when considering all 3 HDRS sleep items (P = .058).Contrasting previous results in healthy subjects, low-dose doxepin does not seem to improve sleep onset or maintenance in patients with MDD. Further research, preferably placebo-controlled, double-blind sleep laboratory trials, is necessary to determine whether low-dose doxepin may be beneficial in this important patient subgroup.