Suvorexant for Post-Traumatic Stress Disorder

Not yet recruiting at 1 trial location

Overseen By Sabra S Inslicht, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: VA Office of Research and Development

Must be taking: SSRIs, SNRIs

Must not be taking: Trazodone, Mirtazapine, Antipsychotics

Disqualifiers: Alcohol use disorder, Bipolar, Schizophrenia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 nights

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests suvorexant, a medication typically used for insomnia, to determine if it can help Veterans with PTSD by reducing symptoms like anxiety and poor sleep. The main goal is to assess whether suvorexant can help these individuals experience less fear in safe situations. Participants will receive either suvorexant or a placebo (a pill with no active medication) to compare results. Veterans who have had PTSD for over three months and also experience insomnia might be suitable for this study. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

You can continue taking certain medications like SSRIs and SNRIs if you have been on a stable dose for at least 4 weeks before joining the trial. However, you must stop using certain antidepressants, mood stabilizers, antipsychotics, benzodiazepines, and some other medications before participating.

What is the safety track record for suvorexant?

Research shows that suvorexant is a safe and well-known medication for treating insomnia. The FDA has approved it for this use, indicating it is generally well-tolerated. In earlier studies, suvorexant showed potential in addressing sleep problems related to PTSD. However, despite its effectiveness for its current use, there is limited real-world information on its long-term safety specifically for PTSD.

Overall, suvorexant appears to be a promising treatment with a good safety record, especially since it is already used for sleep issues. However, like any medication, it may have some side effects or risks that are still under study. ^{1 2 3 4}

Why are researchers enthusiastic about this study treatment?

Suvorexant is unique because it targets orexin receptors in the brain, which play a role in regulating sleep and wakefulness. Unlike traditional treatments for PTSD, which often include SSRIs like sertraline or psychotherapy, suvorexant offers a novel approach by potentially helping patients manage sleep disturbances, a common PTSD symptom. Researchers are excited about this treatment because it offers a new mechanism of action that could provide relief for those who haven't found success with existing options.

What evidence suggests that suvorexant might be an effective treatment for PTSD?

Research has shown that suvorexant, a drug typically used for sleep problems, might also benefit people with PTSD. One study found that participants who took suvorexant experienced noticeable improvements in both PTSD and sleep issues. Suvorexant blocks a brain chemical that keeps individuals awake, potentially reducing fear, a crucial step in overcoming PTSD. Another study demonstrated that suvorexant improved sleep patterns, which is significant because better sleep can help alleviate PTSD symptoms. Although more research is needed, these findings suggest that suvorexant could help manage PTSD symptoms, particularly those related to sleep problems. Participants in this trial will receive either suvorexant or a placebo to further evaluate its effectiveness for PTSD. ^{1 5 6 7 8}

Who Is on the Research Team?

Sabra S Inslicht, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with PTSD and insomnia, focusing on those who experience symptoms like re-experiencing trauma, avoidance, negative thoughts or feelings, and hyperarousal. The study seeks participants who have not found relief through standard treatments.

Inclusion Criteria

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

Exclusion Criteria

Exposure to trauma in the last 3 months

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)

I have a brain condition or illness affecting my nervous system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Proof-of-Concept

Development and establishment of feasibility of the task and recruitment in 40 eligible participants with PTSD and insomnia. Involves a home-based multi-day remote fear conditioning experimental study.

23 months

Remote procedures

Treatment

Participants receive nightly doses of suvorexant or placebo following extinction training over 6 nights.

6 nights

Remote procedures

Follow-up

Participants undergo extinction retention and fear reinstatement tests one week after extinction.

1 week

Remote procedures

What Are the Treatments Tested in This Trial?

Interventions

• Suvorexant

Trial Overview The study tests if Suvorexant (a medication that blocks a brain chemical promoting wakefulness) can help reduce PTSD symptoms by enhancing fear extinction—a process where repeated exposure to feared cues without danger lessens physiological reactions.

How Is the Trial Designed?

Group I: Suvorexant Experimental Treatment 1 Intervention

Suvorexant pills (10-20 mg)

Group II: Placebo Placebo Group 1 Intervention

Matching placebo pills

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a 6-week double-blind, placebo-controlled trial with 37 participants suffering from trauma-related insomnia, suvorexant treatment showed significant improvements in PTSD and insomnia symptoms, although the strong placebo response made it difficult to determine the medication's specific effects.

Suvorexant was well tolerated, with only one participant dropping out due to side effects, and it was associated with increased REM sleep duration, which correlated with a reduction in PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of suvorexant for trauma-related insomnia. Mellman, TA., Birku, K., Sandhu, I., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35554590/

Evaluation of suvorexant for trauma-related insomnia Results: The thirty-seven evaluable participants had significant improvement of PTSD and insomnia symptoms, however, there were no significant ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03642028

Study Details | NCT03642028 | Suvorexant: A Dual Orexin ... It has outstanding promise for treating common and distressing symptoms in Veterans as well as civilians with trauma-related sleep disturbance and PTSD.

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06788522

The Effects of Orexin Antagonism on Fear Extinction in PTSD This study will examine whether suvorexant, a selective orexin-receptor antagonist, will enhance fear extinction in Veterans with PTSD and insomnia.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jsr.70033

The Effect of Suvorexant on Fear Extinction Recall 2016), it remains plausible that suvorexant may improve extinction recall in individuals with PTSD through increased REM sleep disruptions. This ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395621007299

Blocking the orexin system following therapeutic exposure ... We found that suvorexant increased N3 sleep and decreased N2 sleep and rapid-eye-movement latency measured by polysomnography.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12579877/

Pharmacological Management of Post-Traumatic Stress ... Although several medications are used in the clinical practice, post-marketing data on their real-world effectiveness and safety remain limited.

7. withpower.com withpower.com/trial/suvorexant-for-post-traumatic-stress-disorder-2f627

Suvorexant for Post-Traumatic Stress Disorder Suvorexant is an accessible, safe medication that has been well-established in treating insomnia. It has outstanding promise for treating common and distressing ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0361923022001216

Sleep-wake and arousal dysfunctions in post-traumatic ... The DORA Suvorexant increased REM sleep in these animals (Clark et al., 2021). Many more studies need to be performed in animal models of PTSD examining ...