Trial of Suvorexant for Sleep in Children With Autism

NCT05546554 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB-672221P50HD109861
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in sleep efficiency as measured by actigraphy

  Baseline, Week 4 and Week 8

Other Outcomes (11)

• 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

Study Arms (2)

Suvorexant, then Placebo

EXPERIMENTAL

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: Suvorexant; Drug: Placebo

Placebo, then Suvorexant

EXPERIMENTAL

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: Suvorexant; Drug: Placebo

Interventions

Suvorexant DRUG

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

Also known as: Belsomra

Placebo, then Suvorexant; Suvorexant, then Placebo

Placebo DRUG

Matching Placebo given orally

Placebo, then Suvorexant; Suvorexant, then Placebo

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305-5719, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Antonio Y. Hardan, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Villacrucis

CONTACT

(650) 736-1235; acesleepstudy@stanford.edu

Robin Libove

CONTACT

(650) 736-1235; rlibove@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 21, 2022
• Study Start: August 9, 2023
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)