NCT06655883

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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants With Opioid Use Disorder

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep. The goal of this study is to learn about the safety of suvorexant and how well people tolerate it. Researchers also want to learn if suvorexant helps people sleep longer compared to people who take placebo. A placebo looks like the study medicine but has no actual study medicine in it.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Suvorexant	Oral Tablet
DRUG	Placebo	Oral Tablet

Timeline

• Start date: 2025-10-09
• Primary completion: 2027-06-24
• Completion: 2027-06-24
• First posted: 2024-10-24
• Last updated: 2026-04-06

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study