Trial of Suvorexant for Sleep in Children With Autism

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Drug: Placebo; Drug: Suvorexant

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Robin Libove; Phone Number: (650) 736-1235; Email: rlibove@stanford.edu
• Study Contact Backup: Name: Ryan Villacrucis; Phone Number: (650) 736-1235; Email: acesleepstudy@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305-5719
      • Recruiting
      • Stanford University
      • Principal Investigator: Antonio Y. Hardan, MD
      • Contact: Robin Libove; Phone Number: (650) 736-1235; Email: rlibove@stanford.edu
      • Contact: Ryan Villacrucis; Phone Number: (650) 736-1235; Email: acesleepstudy@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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) 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 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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Placebo; Matching Placebo given orally; Drug: Suvorexant; 5 mg (and up to 20 mg) Suvorexant given orally; Other Names: Belsomra
Experimental: 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.	Drug: Placebo; Matching Placebo given orally; Drug: Suvorexant; 5 mg (and up to 20 mg) Suvorexant given orally; Other Names: Belsomra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in sleep efficiency as measured by actigraphy	Baseline, Week 4 and Week 8

Other Outcome Measures

Outcome Measure	Time Frame
Change from baseline on Children's Sleep Habits Questionnaire (CSHQ) subscale scores	Baseline, Week 4 and Week 8
Change from baseline on Aberrant Behavior Checklist, Second Edition (ABC-2) subscale scores	Baseline, Week 4 and Week 8
Change from baseline on Parent Sleep Habits Questionnaire Parent (PSHQ) scores	Baseline, Week 4 and Week 8
Change from baseline on Clinical Global Impression Scale (CGI) scores	Baseline, Week 4 and Week 8
Change from baseline on Child Behavior Checklist (CBCL) scores	Baseline, Week 4 and Week 8
Change from baseline on Social Responsiveness Scale, Second Edition (SRS-2) scores	Baseline, Week 4 and Week 8
Change from baseline on Repetitive Behavior Scale - Revised (RBS-R) scores	Baseline, Week 4 and Week 8
Change from baseline on Sensory Profile Questionnaire (SPQ) scores	Baseline, Week 4 and Week 8
Change from baseline on Stanford Social Dimension Scale (SSDS) scores	Baseline, Week 4 and Week 8
Change from baseline on Dimensional Assessment of Repetitive Behaviors (DARB) score	Baseline, Week 4 and Week 8
Change from baseline on NEuroPSYchological Assessment, 2nd Edition (NEPSY-2) Affect Recognition scores	Baseline, Week 4 and Week 8

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Antonio Y. Hardan, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: autism; Sleep; clinical trial; Suvorexant
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Sleep Aids, Pharmaceutical; Orexin Receptor Antagonists; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Neurotransmitter Agents; Hypnotics and Sedatives; suvorexant
• Other Study ID Numbers: IRB-67222; 1P50HD109861 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will submit de-identified clinical data to the NIMH Data Archive (NDA) data repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No