A Study of Suvorexant (MK-4305) for the Treatment of Inso... | NCT06655883

ID	Type	Description	Link
MK-4305-098	Other Identifier	MSD

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suvorexant	Experimental	Participants receive 10 mg of suvorexant for the first three nights, increased to 20 mg of suvorexant nightly thereafter at the investigator's discretion, for up to approximately 8 weeks.	Drug: Suvorexant
Placebo	Placebo Comparator	Participants receive suvorexant-matching placebo for up to approximately 8 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Suvorexant	Drug	Oral Tablet	Suvorexant	MK-4305

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in Total Sleep Time at 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.	Baseline and Week 8
Number of Participants Who Experience One or More Adverse Events (AEs)	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.	Up to approximately 10 weeks
Number of Participants Who Experience One or More Serious Adverse Events (SAEs)	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.	Up to approximately 10 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE	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.	Up to approximately 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in Wakefulness after Persistent Sleep Onset at Week 8	Wakefulness after persistent sleep onset will be measured in a sleep laboratory by polysomnography at the participant's habitual bedtime. Change from baseline in wakefulness after persistent sleep onset at Week 8 will be reported.	Baseline and Week 8

Eligibility Module

Eligibility Criteria

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 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 Criteria:

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

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.