Actively Recruiting
Trial of Suvorexant for Sleep in Children With Autism
Led by Stanford University · Updated on 2026-03-27
26
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to examine the effect of suvorexant on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Suvorexant is a selective, dual orexin receptor antagonist (DORA) used for the treatment of sleep onset difficulties and/or sleep maintenance. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of suvorexant on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.
CONDITIONS
Official Title
Trial of Suvorexant for Sleep in Children With Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients between 13 and 17 years of age at time of consent
- Diagnosis of Autism Spectrum Disorder (ASD) confirmed by clinical evaluation and standardized tools (ADI-R, ADOS-2, or CARS-2)
- Male or female participants
- Availability of polysomnography (PSG) and/or actigraphy sleep data
- Sleep disturbances indicated by a Children's Sleep Habits Questionnaire (CSHQ) score of 41 or higher and/or sleep efficiency ≤85%, total sleep time <7 hours, or wake after sleep onset >30 minutes measured by PSG or actigraphy
- Caregiver able to reliably bring participant to visits, provide trustworthy ratings, and regularly interact with participant
- Stable medications for at least 2 weeks (except Prozac which must be stable for 4 weeks)
- No planned changes in psychosocial or biomedical treatments during the trial
- Willingness to provide saliva samples and participate in key procedures including safety checks at each visit, PSG at weeks 4 and 8, and wearing an actigraphy watch for 2 weeks before and during the 8-week trial
- Females of childbearing potential who are sexually active must use dual protection contraception (hormonal and barrier methods)
You will not qualify if you...
- Active suicidal thoughts or DSM-5 diagnosis of severe depression, substance use disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
- Unstable medical conditions such as migraine, asthma, seizure disorder, serious liver, kidney, or heart disease, obstructive sleep apnea, or severe liver failure
- Evidence of metabolic or infectious causes for autism based on history and tests
- Pregnant females or sexually active females not using reliable contraception
- Current use of benzodiazepines, antiepileptic drugs for seizures, melatonin, or centrally-acting antihistamines
- History of hypersensitivity or severe side effects to suvorexant
- Prior adequate trial of suvorexant
- Current use of medications that interact with suvorexant such as CYP3A inhibitors
- History of narcolepsy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305-5719
Actively Recruiting
Research Team
R
Ryan Villacrucis
CONTACT
R
Robin Libove
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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