Eszopiclone for the Treatment of Posttraumatic Stress Disorder and Associated Insomnia: A Randomized, Double-Blind, Placebo-Controlled Trial

Objective: The development of novel strategies for the treatment of posttraumatic stress disorder (PTSD) represents a critical public health need. We present the first prospective, randomized, double-blind, placebo-controlled trial of a non-benzodiazepine hypnotic agent for the treatment of PTSD and associated insomnia.

Method: Twenty-four patients with PTSD by DSM-IV criteria and sleep disturbance were treated in a randomized, double-blind, placebo-controlled crossover study of 3 weeks of eszopiclone 3 mg at bedtime compared to placebo. The primary outcome measures were changes in scores on the Short PTSD Rating Interview (SPRINT) and the Pittsburgh Sleep Quality Index (PSQI). The data were collected from April 2006 to June 2008.

Results: Three weeks of eszopiclone pharmacotherapy was associated with significantly greater improvement than placebo on PTSD symptom measures including the SPRINT (P = .032) and the Clinician-Administered PTSD Scale (P = .003), as well as on measures of sleep including the PSQI (P = .011) and sleep latency (P = .044). Greater improvement with eszopiclone on PTSD measures was present even when specific sleep-related items were excluded. Adverse events were consistent with the known profile of the drug.

Conclusions: This study provides initial evidence that pharmacotherapy with eszopiclone may be associated with short-term improvement in overall PTSD severity as well as associated sleep disturbance. Longer, more definitive study of eszopiclone in PTSD is warranted.

Trial Registration: clinicaltrials.gov Identifier: NCT00120250

J Clin Psychiatry 2011;72(7):892-897

Submitted: August 11, 2009; accepted December 17, 2009.

Online ahead of print: February 22, 2010 (doi:10.4088/JCP.09m05607gry).

Corresponding author: Mark H. Pollack, MD, Center for Anxiety and Traumatic Stress Disorders, Massachusetts General Hospital, One Bowdoin Square, Sixth Floor, Boston, MA 02114 (mpollack@partners.org).