Trial of Suvorexant for Sleep in Children With Autism

NCT ID: NCT05546554

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-09
• Study Completion Date: 2028-02-28

Brief Summary

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

Autism; Autism Spectrum Disorder

Keywords

Suvorexant; Sleep; clinical trial; autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Suvorexant, then Placebo

Participants will first receive Suvorexant for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose.

Participants will then receive Placebo (fake tablet) for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

5 mg (and up to 20 mg) Suvorexant given orally

Placebo

Intervention Type: DRUG

Matching Placebo given orally

Placebo, then Suvorexant

Participants will first receive Placebo (fake tablet) for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose.

Participants will then receive Suvorexant for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose.

Group Type: EXPERIMENTAL

Suvorexant

Intervention Type: DRUG

5 mg (and up to 20 mg) Suvorexant given orally

Placebo

Intervention Type: DRUG

Matching Placebo given orally

Interventions

Suvorexant

5 mg (and up to 20 mg) Suvorexant given orally

Intervention Type: DRUG

Placebo

Matching Placebo given orally

Intervention Type: DRUG

Other Intervention Names

Belsomra

Eligibility Criteria

Inclusion Criteria

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)
• 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 Criteria

Participants will be excluded if one or more of the following is met

• 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)
• individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, melatonin and 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Antonio Hardan

Professor of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Y. Hardan, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan Villacrucis

Role: CONTACT

Phone: (650) 736-1235

Email: acesleepstudy@stanford.edu

Robin Libove

Role: CONTACT

Phone: (650) 736-1235

Email: rlibove@stanford.edu

Facility Contacts

Ryan Villacrucis

Role: primary

Robin Libove

Role: backup

Other Identifiers

1P50HD109861

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-67222

Identifier Type: -

Identifier Source: org_study_id