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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
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
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
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.
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.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,467 Previous Clinical Trials
17,496,089 Total Patients Enrolled
36 Trials studying Autism Spectrum Disorder
3,811 Patients Enrolled for Autism Spectrum Disorder
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,607 Total Patients Enrolled
21 Trials studying Autism Spectrum Disorder
2,495 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medications that interact with zolpidem.I do not have active thoughts of suicide or a diagnosis of schizophrenia, schizoaffective, or psychotic disorder.I have tried zolpidem with no success.I have no active major health issues like severe migraines, asthma, seizures, serious illnesses, or liver problems.I have someone who can take me to my clinic visits and help with my care.I am either male or female.I won't change my mental health or medical treatments during the trial.My autism is linked to a known genetic mutation.I am using two forms of birth control.I am between 8 and 17 years old, but will be 12 to 17 years old during the first year.I am currently taking prescribed medications.
Research Study Groups:
This trial has the following groups:- Group 1: Zolpidem, then Placebo
- Group 2: Placebo, then Zolpidem
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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