AutismPhase 2NCT05546554
Trial of Suvorexant for Sleep in Children With Autism
A Phase 2 study testing Suvorexant in people with Autism and Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Suvorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 28 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305-5719
Ryan Villacrucis, (650) 736-1235, acesleepstudy@stanford.edu
Robin Libove, (650) 736-1235, rlibove@stanford.edu
About this study
Official title: 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.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Suvorexant, Placebo
- Keywords
- Suvorexant, Sleep, clinical trial, autism
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvorexantDrug
Also called Belsomra
5 mg (and up to 20 mg) Suvorexant given orally
PlaceboDrug
Matching Placebo given orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Suvorexant; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM)
Measured: Baseline, Week 4 and Week 8
Secondary outcomes (1)
Change from baseline in sleep efficiency as measured by actigraphy
Measured: Baseline, Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start9 Aug 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Y. Hardan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546554
- Sponsor's protocol ID
- IRB-67222
- Other IDs
- 1P50HD109861
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will submit de-identified clinical data to the NIMH Data Archive (NDA) data repository.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Crossover Trial of Suvorexant for Sleep in Children With Autism
- ClinicalTrials.gov ID
- NCT05546554
- Acronym / sponsor ID
- IRB-67222
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- Suvorexant, Sleep, clinical trial, autism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suvorexant, then Placebo | Experimental | Drug: Suvorexant, Drug: PlaceboParticipants 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. |
| Placebo, then Suvorexant | Experimental | Drug: Suvorexant, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuvorexantAlso: Belsomra5 mg (and up to 20 mg) Suvorexant given orally | Drug | Placebo, then Suvorexant, Suvorexant, then Placebo |
| PlaceboMatching Placebo given orally | Drug | Placebo, then Suvorexant, Suvorexant, then Placebo |
Primary outcome
Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM)
Time frame: Baseline, Week 4 and Week 8
1 secondary outcome
Change from baseline in sleep efficiency as measured by actigraphy
Time frame: Baseline, Week 4 and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. We will submit de-identified clinical data to the NIMH Data Archive (NDA) data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Y. Hardan, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suvorexant in people with Autism and Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Villacrucis ((650) 736-1235, acesleepstudy@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM) (time frame: Baseline, Week 4 and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.