What side effects are associated with this type of intervention?

Nonbenzodiazepine GABAa receptor agonists, such as Zolpidem, used in treating sleep disorders in Autism Spectrum Disorder (ASD), commonly cause side effects like dizziness, headache, drowsiness, and gastrointestinal issues such as nausea and diarrhea. There are also risks of complex sleep-related behaviors, including sleepwalking and sleep-driving, as well as cognitive side effects like memory impairment and confusion, especially at higher doses or with prolonged use.

What prior FDA approvals exist?

The FDA has approved two medications specifically for the treatment of irritability associated with Autism Spectrum Disorder: risperidone and aripiprazole. Both are antipsychotic medications and do not share the same mechanism of action as Zolpidem, which is a nonbenzodiazepine GABAa receptor agonist acting as a hypnotic. There are no FDA-approved hypnotic medications specifically for ASD, but ongoing research, such as the trial of Zolpidem, aims to explore potential benefits in managing sleep disturbances in children with ASD.

What other types of research exist?

Promising alternatives to Zolpidem for treating sleep issues in Autism Spectrum Disorder patients include gabapentin and pregabalin, which have shown efficacy in improving sleep duration and quality. Additionally, melatonin and clonidine are also considered effective for sleep disturbances in children and adolescents.

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Zolpidem for Sleep Disturbances 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

Awards & highlights

Summary

This trial is testing zolpidem, a medication that helps people fall asleep, in children and adolescents with Autism Spectrum Disorder (ASD). These children often have trouble sleeping, and typical treatments may not work for them. Zolpidem works by calming the brain, making it easier to fall asleep. Zolpidem is a medication commonly used to treat sleep problems by helping people fall asleep, and it has been studied in various populations including healthy adults and those with insomnia.

Who is the study for?

This trial is for children and adolescents aged 8-17 with Autism Spectrum Disorder who have sleep disturbances. They must not be on certain medications, have stable medication use for the past 4 weeks, and meet specific autism diagnostic criteria. Sexually active females must use dual contraception.

What is being tested?

The study tests Zolpidem's effect on sleep in kids with ASD using a double-blind method where neither doctors nor participants know who gets Zolpidem or placebo. It involves sleep studies, wearing an activity watch, and no changes in treatments during the trial.

What are the potential side effects?

Zolpidem may cause side effects like daytime drowsiness, dizziness, headaches, gastrointestinal issues (nausea), allergic reactions or complex sleep-related behaviors such as sleepwalking.

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: Zolpidem, then PlaceboExperimental Treatment2 Interventions

Participants will first receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated. Participants will then receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.

Group II: Placebo, then ZolpidemExperimental Treatment2 Interventions

Participants will first receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated. Participants will then receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zolpidem

2003

Completed Phase 4

~2490

Placebo

1995

Completed Phase 3

~2670

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 the GABAergic system, which is crucial for regulating neuronal excitability and maintaining the balance between excitation and inhibition in the brain. Zolpidem, a nonbenzodiazepine GABAa receptor agonist, acts as a hypnotic by enhancing the inhibitory effects of GABA, thereby promoting sleep and potentially reducing anxiety and hyperactivity in ASD patients. This is significant for ASD patients as sleep disturbances and heightened anxiety are common comorbidities that can exacerbate core symptoms of autism, such as social deficits and repetitive behaviors. By modulating the GABAergic system, these treatments aim to improve overall neurological function and quality of life for individuals with ASD.

GABAB Receptor Agonist R-Baclofen Reverses Social Deficits and Reduces Repetitive Behavior in Two Mouse Models of Autism.The prevalence, morbidities, and treatments of insomnia.

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,448 Previous Clinical Trials

17,492,368 Total Patients Enrolled

35 Trials studying Autism Spectrum Disorder

4,100 Patients Enrolled for Autism Spectrum Disorder

National Institutes of Health (NIH)NIH

2,765 Previous Clinical Trials

8,133,485 Total Patients Enrolled

21 Trials studying Autism Spectrum Disorder

2,470 Patients Enrolled for Autism Spectrum Disorder

Antonio Y. Hardan, MDPrincipal InvestigatorStanford University

9 Previous Clinical Trials

455 Total Patients Enrolled

8 Trials studying Autism Spectrum Disorder

407 Patients Enrolled for Autism Spectrum Disorder

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05540574 — Phase 2

Autism Spectrum Disorder Research Study Groups: Zolpidem, then Placebo, Placebo, then Zolpidem

Autism Spectrum Disorder Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05540574 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05540574 — Phase 2

~17 spots leftby Apr 2027

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