Actively Recruiting
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
Led by VA Office of Research and Development · Updated on 2025-07-18
190
Participants Needed
4
Research Sites
330 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 75 years with a history of US military service
- Able to read, understand English, and provide written informed consent
- Experienced a Criterion A traumatic event meeting DSM-5 criteria
- PTSD symptoms lasting more than 3 months with a partial PTSD diagnosis at screening
- Insomnia severity index (ISI) score greater than 14
- On stable doses of allowed medications (SSRIs or SNRIs) for at least 4 weeks prior to randomization
- Stable psychotherapy treatment for at least 6 weeks if applicable
- Women of childbearing potential must not be pregnant or breastfeeding and must use effective birth control
- Sleep apnea score less than 30; mild or moderate sleep apnea referred for evaluation
You will not qualify if you...
- Alcohol, marijuana, or other drug use disorder within the last 3 months (mild cases may be allowed individually)
- Manic or psychotic episode in the last 5 years
- Exposure to trauma within the last 3 months
- Prominent suicidal or homicidal thoughts or behaviors in the past 3 months requiring additional therapy
- Severe sleep apnea (score greater than 30) without effective treatment adherence
- Neurologic disorders or systemic illnesses affecting the central nervous system
- Chronic or unstable medical illnesses including unstable angina, recent myocardial infarction, congestive heart failure, hypotension, heart block, chronic renal or hepatic failure, pancreatitis, or severe chronic obstructive pulmonary disease
- History of severe traumatic brain injury
- Mild cognitive impairment
- Pregnancy, breastfeeding, or refusal to use effective birth control (for women)
- Narcolepsy
- Previous adverse reaction to a hypnotic
- Current use of benzodiazepines, strong CYP3A inhibitors, or Digoxin
- Use of CNS depressants such as benzodiazepines, opioids, or alcohol prohibited during the study
- Concomitant use of strong or moderate CYP3A inhibitors or inducers prohibited
- All medication use will be monitored and documented
AI-Screening
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Trial Site Locations
Total: 4 locations
1
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Actively Recruiting
2
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563
Actively Recruiting
3
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, United States, 28144
Actively Recruiting
4
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5703
Actively Recruiting
Research Team
S
Sabra S Inslicht, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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