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Suvorexant for PTSD-Related Sleep Disturbances
Study Summary
This trial will test whether suvorexant, a drug that reduces orexin, can improve sleep disturbances and PTSD symptoms in Veterans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not pregnant, planning to become pregnant, or breastfeeding, and I will use birth control.I have not had a manic or psychotic episode in the last 5 years.I have been on a stable dose of my current medications, including SSRIs or SNRIs, for at least 4 weeks.My psychotherapy treatment has been stable for at least 6 weeks.My sleep apnea score is 30 or I have mild to moderate sleep apnea.I am a veteran aged 18-75, can read English, and can consent to participate.I have been diagnosed with narcolepsy.I am currently taking benzodiazepines, strong CYP3A inhibitors, or Digoxin.I have been on a stable dose of my current medications, including SSRIs or SNRIs, for at least 4 weeks.My psychotherapy treatment has been stable for at least 6 weeks.My sleep apnea score is below 30.I am not taking benzodiazepines, strong CYP3A inhibitors, Digoxin, CNS depressants with suvorexant, or specific CYP3A affecting drugs.I have a long-term or unstable health condition.I have had PTSD symptoms for more than 3 months.I have not had serious thoughts or actions of harming myself or others in the last 3 months.I have a brain disorder or illness affecting my brain function.I have severe sleep apnea not managed by treatment.
- Group 1: Identical Placebo
- Group 2: Suvorexant
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA cleared Suvorexant for public use?
"While Phase 4 trials are not as commonly conducted as earlier phases, this treatment has been approved and is considered safe."
Are there any other scientific papers that mention Suvorexant?
"As of this date, there are 14 active clinical trials testing Suvorexant. 2 of these studies have progressed to Phase 3. The primary research site is located in Silver Spring, Maryland; however, 71 other medical centres across the country are also conducting research on Suvorexant."
How many total people are eligible for this research project?
"That is correct, the online clinicaltrials.gov registry shows that this study is open and recruiting patients. This specific trial was posted on 8/30/2019 and updated as recently as 11/10/2022. The research team is looking to enroll a total of 144 patients at 2 different sites."
Will elderly patients be accepted into this clinical trial?
"Enrolment for this study is open to patients that are between 18-75 years of age."
Might I be eligible to join this clinical research?
"This study is actively recruiting participants who are currently experiencing sleeplessness. In order to be eligible, individuals must meet the following criteria: 18-75 years of age, US military service history, able to read and understand English, ability 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, Sertraline, Paroxetine, Fluoxetine, Fluvoxamine, Citalopram or Escitalopram."
Are there any current vacancies for this research project?
"This is an ongoing clinical trial that was originally posted on August 30th, 2019 and has been actively recruiting patients since. The most recent edit occurred on November 10th, 2020."
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