Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder

Summary

The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.

Timeline

Start

2005-06

Primary completion

2008-06

Completion

2008-06

Outcome

Met primary endpoint

paper significantly greater improvement than placebo on PTSD symptom measures including the SPRINT (P = .032) PMID 21367352 ↗

paper as well as on measures of sleep including the PSQI (P = .011) PMID 21367352 ↗

Publications

• Results Pollack MH, Hoge EA, Worthington JJ, Moshier SJ, Wechsler RS, Brandes M, Simon NM. Eszopiclone for the treatment of posttraumatic stress disorder and associated insomnia: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Jul;72(7):892-7. doi: 10.4088/JCP.09m05607gry. Epub 2011 Feb 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eszopiclone	Small molecule	3 mg	—

Indications