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Suvorexant for Sleep in Children with Autism

This study is looking at how Suvorexant, a medication for sleep problems, affects sleep in children and teenagers with Autism Spectrum Disorder (ASD). Suvorexant helps with falling asleep and staying asleep. Researchers want to see if Suvorexant can improve sleep patterns, like how long it takes to fall asleep, in participants aged 13 to 17 who have been diagnosed with ASD. The study will compare Suvorexant to a placebo (an inactive pill) over 8 weeks. The main way they'll measure success is by looking at changes in sleep using special tests like polysomnography (PSG, a sleep study) and actigraphy (a device that tracks movement and sleep). The current status of this study is unclear, and it plans to enroll 26 participants.

Study design
This is a randomized, double-blind, placebo-controlled crossover study, meaning participants will receive both Suvorexant and a placebo at different times, and neither they nor their doctors will know which they are taking. It plans to enroll 26 participants.
What's involved
Participants will take either Suvorexant or a placebo orally. Sleep will be measured at the beginning of the study, at Week 4, and at Week 8 using polysomnography (PSG) and/or actigraphy.
Compensation
Not stated in the trial record.
Follow-up
Sleep measurements will be taken at Baseline, Week 4, and Week 8.

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

NCT05546554

Trial of Suvorexant for Sleep in Children With Autism

Recruiting
PHASE2Ages 13–17InterventionalBasic science
Stanford University
~26 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:SuvorexantPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM)
Measured over Baseline, Week 4 and Week 8

Conditions

Autism
Autism Spectrum Disorder

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NCT05546554

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford University

    Stanford, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Antonio Y. Hardan, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Ryan Villacrucis
[email protected]
(650) 736-1235
Email the study team

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Eligibility criteria

Inclusion

Outpatients between 13 and 17 years of age at time of consent
Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) or the Childhood Autism Rating Scale, Second Edition (CARS-2)
Males and females
Availability of polysomnography (PSG) and/or actigraphy data
Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 85% or less and/or total sleep time less than 7 hours and/or wake after sleep onset of more than 30 minutes as measured by polysomnography (PSG) or actigraphy
care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis
stable medications for at least 2 weeks, with the exception of Prozac which is required to be stable for at least 4 weeks
no planned changes in psychosocial and biomedical interventions during the trial
willingness to provide additional saliva samples and participate in key study procedures (i.e., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial).
requirement of dual protection contraception use in females who are sexually active and are of childbearing potential. Dual use contraceptive methods involve the use of both a hormonal method (oral contraceptives, long-acting reversible contraceptives, etc.) and a barrier method (condoms).

Exclusion

active suicidal ideation or DSM-5 diagnosis of severe depression, substance use disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
unstable medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology), obstructive sleep apnea and severe hepatic insufficiency
evidence of a metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism
pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)
Benzodiazepines, antiepileptic medications when prescribe for seizure disorder/epilepsy, melatonin and centrally-acting antihistamines
history of hypersensitivity to suvorexant
history of severe side effects from suvorexant
history of adequate trial of suvorexant
current use of any medications known to interact with suvorexant such as medications inhibiting CYP3A
history of narcolepsy

What this trial measures

  • Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM)Baseline, Week 4 and Week 8