Could a common sleep pill boost PTSD treatment in veterans?
NCT ID NCT06788522
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether suvorexant, a medication already approved for insomnia, can help Veterans with PTSD and sleep problems better unlearn fear responses. About 40 Veterans will take either suvorexant or a placebo for 7 nights while researchers measure their skin responses to fear cues. The goal is to see if blocking orexin, a brain chemical that promotes wakefulness, can enhance fear extinction—a key process in PTSD recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Suvorexant
- What this could lead to
- If it works, this could point toward a new way to enhance PTSD treatment by improving how the brain unlearns fear responses.
- What could go wrong
- This is a very small early study (40 participants) focused on lab-based fear measures, not real-world PTSD symptoms. Results may not translate to clinical improvement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40,120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2032
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * (same for Phase 1 and Phase 2): * men and women * a history of US military service * capable of reading and understanding English * able to provide written informed consent * Criterion A event meets DSM-5 criteria and occurred during military service, including combat and military sexual trauma * Chronic full PTSD diagnosis \>3 months duration as indexed by CAPS-5 at screening, and CAPS-5 score \> 30 * Insomnia indicated by insomnia severity index (ISI) score \> 14 * Subjects on non-exclusionary medications, and must be on a stable dose for at least 4 weeks prior to randomization, including Selective Serotonin Reuptake Inhibitors (SSRIs, e.g.,): * sertraline * paroxetine * fluoxetine * fluvoxamine * citalopram * escitalopram * Serotonin-norepinephrine reuptake inhibitors (SNRIs; e.g.): * Desvenlafaxine * Duloxetine * Levomilnacipran * Venlafaxine * For subjects who are in psychotherapy, treatment must be stable for 6 weeks * Women of child-bearing potential must not be pregnant or have plans for pregnancy or breastfeeding during the study and must use a medically acceptable method of birth control Exclusion Criteria: * Moderate or severe DSM-5 alcohol or cannabis use disorder in the last 3 months * Mild alcohol use disorder with abstinence of 30 days will be allowed * Mild marijuana use disorder will be allowed with abstinence for one week prior to participation * Any other DSM-5 drug use disorder in the last 3 months will be excluded * Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features * Exposure to trauma in the last 3 months * Use of exclusionary antidepressant (trazodone, mirtazapine, doxepin, tricyclics), mood stabilizers (e.g., lithium), antipsychotic medication * Prominent suicidal or homicidal ideation or any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS) or increased risk of suicide that necessitates additional therapy or inpatient treatment * Pre-existing moderate sleep apnea or positive screen for sleep apnea by type III device (AHI\>15) in the absence of adherence to effective treatment (such as CPAP or oral device) * Night shift work or extreme morning or evening tendencies in order to avoid the impact of circadian factors on subjective and objective sleep measures * Neurologic disorder or systemic illness affecting CNS function * Chronic or unstable medical illness, including: * unstable angina * myocardial infarction within the past 6 months * congestive heart failure * preexisting hypotension or orthostatic hypotension * heart block or arrhythmia * chronic renal or hepatic failure * pancreatitis * severe chronic obstructive pulmonary disease * History of severe traumatic brain injury as assessed by the Ohio State University Traumatic Brain Injury Identification Method (OSU-TBI ID) * Uncorrected hearing impairment * Mild cognitive impairment assessed by the Montreal Cognitive Assessment (MOCA) * Pregnancy, breastfeeding and/or refusal to use effective birth control (for women) * Previous adverse reaction to a hypnotic * Current use of benzodiazepines, strong inhibitors of CYP3A, or Digoxin * The investigators will require that all participants do not consume heavy amounts of alcohol per week (\>7 drinks for women, \>14 drinks for men) or use illicit drugs for one week prior to participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703, United States
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San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563, United States
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