Sleep drug suvorexant plus talk therapy for PTSD and sleep problems
Tests suvorexant plus PTSD therapy in veterans who sleep poorly.
Key facts
- Who runs it
- Northern California Institute of Research and Education
- Where
- San Francisco, United StatesSee the site
- Trial code
- Registry title
- Suvorexant 3 - PE-PC
- Status
- Not yet recruiting
- Phase
- Phase 4
- People taking part
- 142 people, planned
- Started
- 1 Sept 2026
- Expected to end
- 30 Aug 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Suvorexant
- Placebo
- Prolonged Exposure Therapy for Primary Care (PE-PC)
- Record updated
- 7 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for U.S. military Veterans aged 18-75 with PTSD and insomnia, with or without mild-to-moderate traumatic brain injury. They get PE-PC talk therapy plus suvorexant or a placebo.
- Age
- 18 to 75 years
- Sex
- All sexes
- Disease stage
- Current PTSD lasting more than 3 months after a serious traumatic event, with a CAPS-5 total score of 12 or more. Insomnia with an ISI score above 14.
- Earlier treatment
- Mental health medicines that are allowed must be at a stable dose for at least 4 weeks before the start. Supportive talk therapy must be stable for at least 6 weeks. People cannot be in exposure-based PTSD therapy or behavioral insomnia treatment now.
Main reasons for not taking part
- Alcohol, marijuana or other substance use disorder in the last 3 months
- Bipolar disorder, schizophrenia, schizoaffective disorder, OCD, or depression with psychotic features at any time
- Trauma in the last 3 months, or serious suicidal thoughts or suicidal behavior in the past 3 months
- Untreated sleep apnea, night shift work, or serious heart, kidney, liver, lung or brain illness
- Pregnancy or breastfeeding, or current use of sleeping pills, benzodiazepines, some CYP3A drugs or Digoxin
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- Adults 18-75 years who are U.S. military Veterans; able to read/understand English and provide written informed consent
- Exposure to a DSM-5 Criterion A traumatic event
- Current PTSD, duration > 3 months, CAPS-5 total score ≥ 12
- Insomnia diagnosis indicated by ISI score >14
- If taking non-exclusionary psychotropics (e.g., SSRI/SNRI, tetracyclic antidepressants, tricyclics, antipsychotics, and mood stabilizers, insomnia medication, neuroleptics, anti-psychotics) must be on a dose stable ≥ 4 weeks before randomization
- If in supportive psychotherapy, stable ≥ 6 weeks before randomization (no concurrent exposure-based PTSD or CBT-I)
- Women of childbearing potential: negative urine pregnancy test at screening; agree to use a medically acceptable contraception method during treatment
Who cannot take part
- Prominent suicidal or homicidal ideation, any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS)83, or increased risk of suicide that necessitates additional therapy or inpatient treatment
- Previous adverse reaction to a hypnotic
- Current use of sedative-hypnotics, benzodiazepines, moderate or strong CYP3A inhibitors, or strong CYP3A inducers or Digoxin
- DSM-5 alcohol, marijuana, and/or other substance use disorder in the last 3 months. Mild alcohol and marijuana use not meeting criteria for disorder permissible
- Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features
- Neurologic disorder or systemic illness affecting CNS function
- Chronic or unstable medical illness (i.e., 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, and severe chronic obstructive pulmonary disease)
- Severe cognitive impairment as assessed by the MoCA (or alternative validated threshold per site SOP)
- Exposure to trauma in the last 3 months
- Pre-existing sleep apnea by type III device with 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
- Pregnancy or breastfeeding, or unwillingness to use effective contraception (women of childbearing potential)
- Current participation in exposure-based PTSD or behavioral insomnia treatments
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
- San Francisco VA Health Care SystemSan Francisco, United StatesContact: Sabra Inslicht, PhDNot yet recruiting
About the trial
What the trial wants to find out
The goal of this clinical trial is to learn if combining suvorexant (a sleep medication) with a shorter form of prolonged exposure therapy called PE-PC works to treat PTSD symptoms and improve sleep in Veterans and military personnel with PTSD and insomnia, with and without mild-to-moderate traumatic brain injury (TBI). The main questions it aims to answer are:
Read full original descriptionShow less
Does suvorexant, when combined with PE-PC therapy, reduce PTSD symptoms more than PE-PC with a placebo (a look-alike substance that contains no drug)? Does suvorexant, when combined with PE-PC therapy, improve psychosocial and physical functioning more than PE-PC with a placebo?
Researchers will compare PE-PC combined with suvorexant to PE-PC combined with a placebo to see if adding suvorexant improves PTSD symptoms, sleep, and overall functioning in Veterans.
Participants will:
Receive weekly PE-PC therapy sessions for 8 weeks Take suvorexant (10-20 mg) or a placebo each night during the 8-week treatment period.
Complete repeated assessments of PTSD symptoms, sleep, and psychosocial and physical functioning throughout the study.
The 2 groups in the trial
- PE-PC + SuvorexantExisting treatment, for comparison
PE-PC with suvorexant
Treatment: Suvorexant and Prolonged Exposure Therapy for Primary Care (PE-PC)
- PE-PC + PlaceboPlacebo, for comparison
PE-PC with placebo
Treatment: Placebo and Prolonged Exposure Therapy for Primary Care (PE-PC)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Suvorexant: Targeting Orexin to Augment Exposure Therapy in Veterans With PTSD and Insomnia
- Plain-language title
- Sleep drug suvorexant plus talk therapy for PTSD and sleep problemsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07686731, who can take part
- Record updated
- 7 July 2026