Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Office of Research and Development

About this trial

Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health conditions, such as metabolic syndrome, inflammation, and cardiovascular disease. The orexin neuropeptide system underlies both sleep and stress reactivity. Suvorexant, a drug that reduces orexin, improves sleep in civilians, but has not yet been tested in Veterans with PTSD. This study will test whether suvorexant can improve sleep disturbances and PTSD symptoms in Veterans. Suvorexant may benefit Veterans by improving sleep quickly while also reducing PTSD symptoms over the long term, and with fewer side effects that were common in previous medications used to treat these conditions. Improving Veterans' sleep and PTSD symptoms could lead to better emotional and physical well-being, quality of life, relationships, and functioning.

Eligibility criteria

Qualifiers

Men and Women, age range of 18 to 75, with a history of US military service, capable of reading and understanding English, and able to provide written informed consent

Criterion A event meets DSM-5 criteria

PTSD symptoms >3 months duration as indexed by a CAPS-5 12 and a partial PTSD diagnosis at screening

Insomnia indicated by an ISI score > 14

Disqualifiers

DSM-5 alcohol, marijuana, and/or other drug use disorder in the last 3 months

Mild alcohol use not meeting criteria for moderate or severe use disorder may be allowed on a case-by-case basis

Mild or moderate marijuana use disorder may be allowed on a on a case-by-case basis

Manic or psychotic episode in the last 5 years

Trial design

Treatments tested in this trial

  • Suvorexant
  • Placebo

Treatment groups

190 Participants
are divided into 2 treatment groups