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Suvorexant for Insomnia in Opioid Use Disorder

This study is looking at whether suvorexant (an oral tablet) can help people with opioid use disorder (OUD) who have trouble falling or staying asleep. Researchers want to see if suvorexant is safe, how well people tolerate it, and if it helps them sleep longer compared to a placebo (a pill with no medicine). You could be eligible if you are between 18 and 70 years old, have a primary diagnosis of OUD, and are on a stable dose of medication for OUD treatment. The study aims to measure how much your total sleep time changes after 8 weeks and track any side effects for about 10 weeks. The current status of this study is unclear.

Study design
This study plans to enroll 300 participants. It compares suvorexant to a placebo, which looks like the study medicine but has no actual medicine in it.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your total sleep time will be measured at the beginning and after 8 weeks. Any side effects will be tracked for up to about 10 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06655883

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

Recruiting
PHASE3Ages 18–70InterventionalTreatment
Merck Sharp & Dohme LLC
~300 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:SuvorexantPlacebo

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Total Sleep Time at Week 8
Measured over Baseline and Week 8
+3 more outcomes measured

Conditions

Insomnia

Explore related trials

InsomniaOpioid Use Disorder

Where it's being run

13 sites across 12 states
Texas2
California1
Connecticut1
Florida1
Georgia1
Maryland1
New Jersey1
Oklahoma1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has a primary diagnosis of OUD according to Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5), and confirmed through the Mini International Neuropsychiatric Interview (MINI).
Is on a verified, stable dose of medications for opioid use disorder (MOUD) treatment.
Meets DSM-5 criteria for the diagnosis of Insomnia Disorder
Has a regular bedtime between 8 PM (20:00) and 1 AM (01:00) and is willing to maintain it for the duration of the study.
Has not used opioids for a period of at least 4 weeks before entering the study.

Exclusion

Has current uncontrolled major co-morbid psychiatric illness including major depressive disorder, bipolar disorder, 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) behavior disorder, significant degree of sleep-related breathing disorder, excessive daytime sleepiness (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 may be responsible for the participant's disturbed sleep.
Has a history of malignancy, ≤3 years prior to start of study, with the exception of nonmelanoma skin cancer, prostate cancer or localized carcinoma in situ of the cervix.
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 transmeridian travel within 2 weeks prior to start of study.

What this trial measures

  • Change from Baseline in Total Sleep Time at Week 8Baseline and Week 8

    Total sleep time will be measured in a sleep laboratory by polysomnography at the participant's habitual bedtime. Change from baseline in total sleep time at Week 8 will be reported.

  • Number of Participants Who Experience One or More Adverse Events (AEs)Up to approximately 10 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  • Number of Participants Who Experience One or More Serious Adverse Events (SAEs)Up to approximately 10 weeks

    An SAE is any untoward medical occurrence that at any dose results in death, is life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is another important medical event deemed such by medical or scientific judgement.

  • Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 8 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.