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Suvorexant for Sleep and PTSD in Veterans

This study is looking at whether a drug called suvorexant can help Veterans with post-traumatic stress disorder (PTSD) who also have trouble sleeping. Suvorexant works by targeting the orexin system, which is involved in both sleep and stress. Researchers want to see if suvorexant can improve sleep problems and PTSD symptoms over 12 weeks. You might be able to join if you are a Veteran between 18 and 75 years old, have served in the US military, have had PTSD symptoms for more than 3 months, and have significant insomnia. The study is currently unclear about its recruitment status.

Study design
This is a randomized, double-blind, placebo-controlled study involving about 190 participants. Participants will receive either suvorexant or a placebo (an inactive pill that looks the same).
What's involved
Participants will take study medication for 12 weeks, with an initial 2-week dose adjustment period. Researchers will measure changes in insomnia and PTSD symptoms over this time.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for the study are taken at 12 weeks after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03642028

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

Recruiting
PHASE4Ages 18–75InterventionalTreatment
VA Office of Research and Development
~190 participants
Updated 2025-07-18 on ClinicalTrials.gov
What's tested:SuvorexantPlacebo

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia Severity Index (ISI)
Measured over Change from baseline to week 12
+1 more outcome measured

Conditions

Sleep Initiation and Maintenance Disorders
Stress Disorders, Posttraumatic

Explore related trials

InsomniaPost-Traumatic Stress Disorder

Where it's being run

4 sites across 3 states
California2
North Carolina1
South Carolina1

Study leadership

  • Sabra S Inslicht, PhD · PRINCIPAL_INVESTIGATOR · San Francisco VA Medical Center, San Francisco, CA

Who to contact

Sabra S Inslicht, PhD
[email protected]
(415) 221-4810 · ext. 3341
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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
Subjects on non-exclusionary medications must be on a stable dose for at least 4 weeks prior to randomization, which includes the 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, e.g.:
oral
implantable
injectable
transdermal contraceptive
intrauterine device
double-barrier method
Sleep apnea score \<30; if screening indicates mild or moderate sleep apnea (score between 5 and 30), referral will be provided

Exclusion

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
Exposure to trauma in the last 3 months
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 severe sleep apnea (score \>30) in the absence of adherence to effective treatment (such as CPAP or oral device) or positive screen for severe sleep apnea by type III device (score \> 30)
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
Mild cognitive impairment assessed by the Montreal Cognitive Assessment
Pregnancy, breastfeeding and/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
benzodiazepines
strong CYP3A inhibitors
Digoxin
Furthermore, CNS depressants (e.g., benzodiazepines, opioids, alcohol) increase the risk of CNS depression when co-administered with suvorexant and will not be allowed for safety reasons.
Since metabolism by CYP3A is the major elimination pathway for suvorexant, concomitant use of suvorexant with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan), moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil), or strong CYP3A inducers (e.g., rifampin, carbamazepine and phenytoin) will not be allowed.
All concomitant medication use will be monitored and documented

What this trial measures

  • Insomnia Severity Index (ISI)Change from baseline to week 12

    The ISI is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems.

  • Clinician Administered PTSD Scale for DSM-5 (CAPS-5)Change from baseline to week 12

    The CAPS-5 is a 30-item interview that is the gold standard assessment for PTSD. The CAPS-5 provides a dimensional and categorical measure of PTSD, and incorporates frequency and intensity of symptoms into a single severity score. The CAPS-5 will determine a threshold for PTSD severity (past week) at baseline (excluding change in item #20 falling and staying asleep). Possible scores range from 0 to 80. All trained and certified CAPS-raters will function independently and will not be involved in recruitment, study coordination, or evaluation of side effects.