Trial of Suvorexant for Sleep in Children With Autism

• Suvorexant (Drug), also known as Belsomra: 5 mg (and up to 20 mg) Suvorexant given orally
• Placebo (Drug): Matching Placebo given orally

Primary outcomes

• 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

• Change from baseline in sleep efficiency as measured by actigraphy [Baseline, Week 4 and Week 8]

Other outcomes

• 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]

Sex: All, ages: 13 Years to 17 Years, accepts healthy volunteers

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

• Antonio Y. Hardan, MD, Principal investigator, Stanford University

NIH grants: P50HD109861