Suvorexant for Sleep Issues in Children with Autism
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?
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Suvorexant or Placebo for a 4-week period, followed by crossover to the alternate treatment for another 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Suvorexant
Suvorexant is already approved in United States, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
National Institutes of Health (NIH)
Collaborator