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

Phase

Condition

Insomnia

Opioid Use Disorder

Treatment

Placebo

Suvorexant

Clinical Study ID

NCT06655883

4305-098

MK-4305-098

Ages 18-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has a diagnosis of OUD and is currently in treatment for OUD.
Is on a verified, stable dose of medications for opioid use disorder (MOUD)treatment.
Has sleep complaints that meet Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for the diagnosis of insomnia.
Has a regular bedtime between 8 PM (20:00) and 1 AM (01:00) and is willing tomaintain it for the duration of the study.

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has current uncontrolled major co-morbid psychiatric illness including bipolardisorder, schizophrenia, or any psychiatric condition with psychotic features.
Has current diagnosis or history within 5 years of any of the following: narcolepsy,sleep paralysis, severe periodic limb movement disorder, restless leg syndrome,cataplexy, circadian rhythm sleep disorder, parasomnia including nightmare disorder,sleep terror disorder, sleepwalking disorder, rapid eye movement (REM) behaviordisorder, significant degree of sleep-related breathing disorder, excessive daytimesleepiness (EDS), or primary hypersomnia.
Is at imminent risk of self-harm.
Has a known history of stroke that may confound the diagnosis of insomnia.
Has a clinically significant movement disorder such as akinesia.
Has a history of hepatitis or live disease.
Has habitual use of central nervous system (CNS)-depressants or stimulants that maybe responsible for the participant's disturbed sleep.
Has a history of malignancy, ≤3 years prior to start of study, with the exception ofnon-melanoma skin cancer, prostate cancer or localized carcinoma in situ of thecervix.
Has a history of hypersensitivity to more than 3 chemical classes of drugs,including prescription and over-the-counter medications.
Has donated blood products or had phlebotomy within 8 weeks prior to start of study.
Has a history of trans-meridian travel within 2 weeks prior to start of study.

Study Design

Placebo

June 16, 2025

October 06, 2026