Suvorexant for Insomnia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether suvorexant, a medication for insomnia, can aid individuals with opioid use disorder (OUD) who experience sleep difficulties. Researchers aim to determine if this medication helps these individuals fall asleep more easily and stay asleep longer compared to a placebo, which resembles the actual medicine but contains no active ingredients. The study will also assess the drug's safety and tolerability. Ideal candidates for this trial have OUD, are on stable treatment medication, struggle with insomnia, have not used opioids for at least four weeks, and maintain a regular bedtime. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of medications for opioid use disorder. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that suvorexant is likely to be safe for humans?
Research has shown that suvorexant is generally safe and effective for treating insomnia. A primary side effect is daytime sleepiness, which can impact activities such as driving. In studies where participants used suvorexant for three months, this was the most commonly reported issue.
The FDA has approved suvorexant for treating insomnia, indicating it has passed safety checks for this use. However, its safety and effectiveness may vary when used for other conditions, such as improving sleep in individuals with opioid use disorder. Overall, suvorexant is considered safe, but discussing any concerns or specific health conditions with a doctor is always advisable.12345Why do researchers think this study treatment might be promising?
Unlike the standard insomnia treatments that often involve sedatives or hypnotics, suvorexant works by targeting and blocking orexin receptors, which are responsible for wakefulness. This unique mechanism helps regulate sleep without the same risk of dependence or next-day grogginess associated with traditional options like benzodiazepines or non-benzodiazepine sleep aids. Researchers are excited about suvorexant because it offers a novel approach to managing insomnia, potentially providing a safer and more effective long-term solution for those struggling with sleep issues.
What evidence suggests that suvorexant might be an effective treatment for insomnia in people with opioid use disorder?
Research shows that suvorexant, which participants in this trial may receive, effectively treats insomnia. Studies have found that people taking suvorexant stay asleep longer than those taking a placebo. Specifically, those using a 20 mg dose experienced significant improvements in both falling asleep and staying asleep over several months. These findings suggest that suvorexant might help individuals with opioid use disorder who have trouble sleeping. The medication blocks certain brain signals that maintain wakefulness, making it easier to fall asleep.15678
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with opioid use disorder (OUD) who are currently being treated and on a stable dose of medication. Participants should have sleep issues meeting the criteria for insomnia and maintain a regular bedtime between 8 PM and 1 AM throughout the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either suvorexant or placebo for up to approximately 8 weeks to evaluate the efficacy and safety of suvorexant for the treatment of insomnia in participants with opioid use disorder.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and substance use.
What Are the Treatments Tested in This Trial?
Interventions
- Suvorexant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University