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

Last updated: March 20, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Opioid Use Disorder

Insomnia

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 primary diagnosis of OUD according to Diagnostic and Statistical Manual ofMental Disorder, 5th Edition (DSM-5), and confirmed through the Mini InternationalNeuropsychiatric 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 tomaintain it for the duration of the study.

  • Has not used opioids for a period of at least 4 weeks before entering 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 majordepressive disorder, bipolar disorder, schizophrenia, or any psychiatric conditionwith 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 ofnonmelanoma 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 transmeridian travel within 2 weeks prior to start of study.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 09, 2025
Estimated Completion Date:
June 24, 2027

Connect with a study center

  • Yale University School of Medicine ( Site 1003)

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • CenExel iResearch, LLC ( Site 2010)

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Johns Hopkins University ( Site 1001)

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Johns Hopkins University ( Site 1001)

    Baltimore 4347778, Maryland 4361885 21224
    United States

    Site Not Available

  • Hassman Research Institute Marlton Site ( Site 2005)

    Marlton, New Jersey 08053
    United States

    Active - Recruiting

  • The Rivus Wellness & Research Institute ( Site 2014)

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • The Rivus Wellness & Research Institute ( Site 2014)

    Oklahoma City 4544349, Oklahoma 4544379 73112
    United States

    Site Not Available

  • Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Penn Medicine University of Pennsylvania Health System- Center for Studies of Addiction ( Site 1006)

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Butler Hospital ( Site 1002)

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

  • Butler Hospital ( Site 1002)

    Providence 5224151, Rhode Island 5224323 02906
    United States

    Site Not Available

  • Medical University of South Carolina ( Site 1005)

    Charleston, South Carolina 29403
    United States

    Active - Recruiting

  • Medical University of South Carolina ( Site 1005)

    Charleston 4574324, South Carolina 4597040 29403
    United States

    Site Not Available

  • Adams Clinical Dallas ( Site 2007)

    DeSoto, Texas 75115
    United States

    Active - Recruiting

  • Memorial Hermann Village ( Site 2001)

    Houston, Texas 77043
    United States

    Active - Recruiting

  • Adams Clinical Dallas ( Site 2007)

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Memorial Hermann Village ( Site 2001)

    Houston 4699066, Texas 4736286 77043
    United States

    Site Not Available

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