Tests suvorexant for sleep problems in teens with autism

Trial details

Who runs it

Stanford University

Trial code

NCT05546554

Record updated

27 March 2026

Original description

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.Read full original descriptionShow less

Randomized Placebo-Controlled Crossover Trial of Suvorexant for Sleep in Children With Autism

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.

Inclusion: Participants will meet the following; 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: current use of any medications known to interact with suvorexant such as medications inhibiting CYP3A; 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; 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; history of narcolepsy; Participants will be excluded if one or more of the following is met; 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).

ClinicalTrials.gov NCT05546554