Phase 3 Study to Test the Safety and Effectiveness of Suvorexant for Treating Insomnia in Adults With Opioid Use Disorder

What this Trial Is About

This research aims to study people with opioid use disorder OUD who often have difficulty falling asleep or staying asleep. The goal is to evaluate the safety and tolerability of suvorexant, a medication being studied for insomnia in this group. Researchers also want to find out if suvorexant helps people with OUD sleep longer compared to those taking a placebo, which looks like the medicine but contains no active drug. Participants in the study will be randomly assigned to receive either suvorexant or a matching placebo for about 8 weeks. Those taking suvorexant will start with 10 mg for the first three nights, then may increase to 20 mg nightly as decided by the study doctor. The study is designed as a double-blind, meaning neither participants nor researchers know who receives the medicine or placebo during the trial. During the study, participants will have their sleep time and wakefulness measured at the start and after 8 weeks. Researchers will monitor any side effects or serious events throughout the approximately 10-week period. Drug use will be assessed multiple times with urine tests. The study runs from October 2025 to June 2027, with safety and sleep outcomes carefully tracked to learn about suvorexants effects in people with OUD-related insomnia.

A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)