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Doxepin for Insomnia: A Systematic Review of Randomized Placebo-controlled Trials
Sleep Medicine Reviews , 07/29/14
Yeung WF, et al. – Doxepin, a sedating tricyclic drug, was recently approved by the U.S. Food and Drug Administration (FDA) at 3 mg and 6 mg doses for the treatment of insomnia. This systematic review evaluated the efficacy and safety of doxepin as a hypnotic. The researchers concluded that low–dose doxepin for 1–2 nights appeared to be safe and effective in improving sleep. However, a clear conclusion on its short–term benefits and risks as well as withdrawal effects was not possible due to the small number of studies.
  • Researchers searched key databases and trial registers up to March 2014 and contacted pharmaceutical companies and the FDA for unpublished data.
  • A total of 9 randomized placebo–controlled trials were analyzed.
  • 6 studies were on doxepin 1–6 mg/d, 2 on doxepin 25–300 mg/d, and one on ramelteon 8 mg and doxepin 3 mg combined.
  • All low–dose studies were industry sponsored.

  • Low–dose doxepin had a small to medium effect size against placebo for sleep maintenance and sleep duration, but not for sleep initiation, at both immediate and short–term posttreatment.
  • There was no significant next–day residual effect with low–dose doxepin.
  • Headache and somnolence were the most common side effects.

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