26 Participants Needed

Suvorexant for Sleep Issues in Children with Autism

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Overseen ByEmma Baker, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing suvorexant, a sleep aid, in children and adolescents with Autism Spectrum Disorder who have sleep problems. Suvorexant helps people fall asleep and stay asleep by blocking wakefulness signals in the brain.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, like beta-blockers, benzodiazepines, antiepileptic medications, melatonin, and antihistamines, as they are not allowed in the trial. If you are on Prozac, it must be stable for at least 4 weeks before joining the study.

Is Suvorexant safe for use in humans?

Suvorexant, used for treating insomnia, is generally considered safe and well-tolerated in adults, but it can cause side effects like next-morning drowsiness, muscle weakness, unusual dreams, sleepwalking, and other nighttime behaviors. It has been tested in healthy adults and elderly patients, with some concerns about safe dosing and rare adverse effects.12345

How is the drug Suvorexant unique for treating sleep issues in children with autism?

Suvorexant is unique because it works by blocking orexin receptors, which are involved in wakefulness, making it different from other sleep medications that often target different pathways. This novel mechanism helps promote sleep without the same sedative effects as traditional sleep aids.13467

Who Is on the Research Team?

Antonio Hardan, M.D. | Stanford Medicine

Antonio Hardan, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children aged 13-17 with Autism Spectrum Disorder who have sleep issues, confirmed by clinical evaluation and specific tests. They must be on stable medications, willing to undergo sleep studies, and not planning any treatment changes during the study. Sexually active females must use dual contraception.

Inclusion Criteria

Willingness to provide additional saliva samples and participate in key study procedures
I am between 13 and 17 years old.
Stable medications for at least 4 weeks
See 7 more

Exclusion Criteria

I have tried suvorexant with no success.
History of narcolepsy
I am currently taking prescribed medications.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Suvorexant or Placebo for a 4-week period, followed by crossover to the alternate treatment for another 4 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Suvorexant
Trial Overview The trial is testing Suvorexant's effects on sleep in autistic children compared to a placebo. It's an 8-week study where participants are randomly assigned to receive either the drug or placebo first, then switch halfway without knowing which one they're taking.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Suvorexant, then PlaceboExperimental Treatment2 Interventions
Group II: Placebo, then SuvorexantExperimental Treatment2 Interventions

Suvorexant is already approved in United States, Japan for the following indications:

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Approved in United States as Belsomra for:
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Approved in Japan as Belsomra for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Published Research Related to This Trial

Suvorexant, the first orexin receptor antagonist approved by the FDA for treating insomnia, has been shown to effectively induce and maintain sleep in adult and elderly patients over treatment periods of up to 12 months.
While the FDA approved doses of 5, 10, 15, and 20 mg due to concerns about safety and next-morning effects like somnolence and unusual behaviors, suvorexant represents a novel approach to insomnia treatment, potentially leading to new therapies targeting orexin receptors.
Suvorexant for the treatment of insomnia.Jacobson, LH., Callander, GE., Hoyer, D.[2015]
Suvorexant, a new medication for insomnia, is generally considered safe and well tolerated in most patients.
However, there is a rare but significant adverse effect associated with suvorexant in patients with Parkinson's disease, highlighting the need for careful monitoring in this population.
Suvorexant-Induced Dream Enactment Behavior in Parkinson Disease: A Case Report.Tabata, H., Kuriyama, A., Yamao, F., et al.[2018]
A reliable liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed to measure suvorexant levels in human plasma, demonstrating high precision and accuracy across a wide concentration range (1-1000 ng/mL).
The method has been validated for stability and can support clinical studies for suvorexant, showing that plasma samples remain stable for up to 25 months at -20°C, which is crucial for long-term studies.
Determination of suvorexant in human plasma using 96-well liquid-liquid extraction and HPLC with tandem mass spectrometric detection.Breidinger, SA., Simpson, RC., Mangin, E., et al.[2019]

Citations

Suvorexant for the treatment of insomnia. [2015]
Suvorexant-Induced Dream Enactment Behavior in Parkinson Disease: A Case Report. [2018]
Determination of suvorexant in human plasma using 96-well liquid-liquid extraction and HPLC with tandem mass spectrometric detection. [2019]
Safety, Tolerability, and Pharmacokinetics of Suvorexant: A Randomized Rising-Dose Trial in Healthy Men. [2019]
Suvorexant for insomnia: a systematic review of the efficacy and safety profile for this newly approved hypnotic - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? [2018]
Identification of Suvorexant in Urine Using Liquid Chromatography-Quadrupole/Time-of-Flight Mass Spectrometry (LC-Q/TOF-MS). [2017]
Study protocol for a randomised controlled trial evaluating the effects of the orexin receptor antagonist suvorexant on sleep architecture and delirium in the intensive care unit. [2021]
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