What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) include medications like atomoxetine and dual orexin receptor antagonists (DORAs) such as Suvorexant. Atomoxetine, used for managing ADHD symptoms in ASD, can cause side effects like nausea, decreased appetite, fatigue, and early morning awakening. Suvorexant, primarily used for sleep issues, may cause drowsiness, headache, and dizziness. Both medications are generally well-tolerated, but careful monitoring for adverse effects is recommended.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting sleep issues in Autism Spectrum Disorder (ASD) using Dual Orexin Receptor Antagonists (DORAs) like Suvorexant. The primary FDA-approved medications for ASD focus on managing irritability and behavioral symptoms, such as Risperidone and Aripiprazole. These antipsychotic drugs help reduce aggression, self-injury, and severe tantrums in children with ASD. While Suvorexant is being studied for its potential benefits in improving sleep in children with ASD, it has not yet received FDA approval for this specific use.

What other types of research exist?

A promising alternative to Suvorexant for treating sleep issues in Autism Spectrum Disorder patients is ramelteon, a melatonin receptor agonist. It has demonstrated effectiveness in treating both insomnia and behavioral symptoms in autistic patients.

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Dual Orexin Receptor Antagonist

Suvorexant for Sleep Issues in Children with Autism

Phase 2

Recruiting

Led By Antonio Y. Hardan, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Suvorexant may cause side effects like daytime drowsiness, headaches, dizziness, dry mouth, coughing or wheezing; it can also potentially worsen depression or suicidal thoughts in those at risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Group I: Suvorexant, then PlaceboExperimental Treatment2 Interventions

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.

Group II: Placebo, then SuvorexantExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Suvorexant

2016

Completed Phase 4

~2200

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) often target sleep disturbances, a prevalent issue in ASD patients. Suvorexant, a Dual Orexin Receptor Antagonist (DORA), works by inhibiting the action of orexin, a neurotransmitter that regulates wakefulness, thereby promoting sleep onset and maintenance. Melatonin, a hormone that regulates the sleep-wake cycle, is another common treatment that helps improve sleep quality in ASD patients. Clonidine, an alpha-2 adrenergic agonist, is also used to address sleep issues by reducing hyperarousal. These treatments are significant for ASD patients as they help manage sleep disturbances, which can exacerbate other ASD symptoms and negatively impact overall functioning and quality of life.

Evaluation of drug interventions for the treatment of sleep disorders in children with autism spectrum disorders: a systematic review.[Psychopharmacology of autistic disorders].