Phase 2 Autism Spectrum Disorder Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 13 and 17 years old and are being seen as an outpatient (not currently admitted to a hospital).
- You have been diagnosed with Autism Spectrum Disorder (ASD), confirmed through specific standard diagnostic tools used by clinicians.
- You are male or female.
- You have sleep problem data available from a sleep study (done in a lab) and/or a wrist-worn sleep tracking device.
- You have sleep difficulties, such as poor sleep quality, sleeping less than 7 hours, or waking up for more than 30 minutes during the night, as measured by specific sleep assessments.
- You have a caregiver who can reliably bring you to appointments, give accurate feedback about you, and sees you regularly.
- Any medications you take have been at a stable dose for at least 2 weeks (or at least 4 weeks if you take Prozac/fluoxetine).
- No changes to your current treatments or therapies are planned during the trial.
- You are willing to provide saliva samples, attend safety check-ins at every visit, complete sleep lab studies at weeks 4 and 8, and wear a sleep-tracking watch for 2 weeks before and throughout the 8-week trial.
- If you are female, sexually active, and able to become pregnant, you are willing to use two forms of contraception at the same time (one hormonal, one barrier method such as a condom).
Who may not be able to join:
- You are currently having thoughts of suicide, or have been diagnosed with severe depression, a substance use disorder, schizophrenia, schizoaffective disorder, or a psychotic disorder.
- You have unstable health conditions such as migraines, asthma, a seizure disorder, serious liver, kidney, or heart problems, a severe allergic condition (such as anaphylaxis), obstructive sleep apnea, or severe liver failure.
- There is evidence that your autism may be caused by a metabolic or infectious condition, based on your medical history or test results.
- You are pregnant, or you are a sexually active female who is not using a reliable form of contraception (pregnancy tests will be used in this study).
- You currently take certain medications including benzodiazepines, anti-epileptic drugs prescribed specifically for seizures/epilepsy, melatonin, or antihistamines that affect the brain.
- You have ever had an allergic reaction to the study drug, suvorexant.
- You have previously had severe side effects from suvorexant.
- You have already had a full, adequate course of treatment with suvorexant.
- You currently take medications known to interact with suvorexant, such as those that affect a liver enzyme called CYP3A (confirm with trial site).
- You have a history of narcolepsy (a condition causing sudden, uncontrollable sleep attacks).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Antonio Y. Hardan, MD, Stanford University
Phone: (650) 736-1235
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.