Zolpidem for Sleep Disturbances in Children with Autism

Overseen By Ryan Villacrucis

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Beta-blockers, Benzodiazepines, Antidepressants, others

Disqualifiers: Schizophrenia, Seizure disorder, Liver pathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines zolpidem, a medication that aids sleep, to determine if it can improve sleep in children and teenagers with Autism Spectrum Disorder (ASD) who struggle with falling or staying asleep. Participants will begin with either zolpidem or a placebo (a non-active pill) for four weeks, then switch to the other option. The trial suits children aged 12-17 with ASD who have noticeable sleep issues and can attend regular clinic visits with a caregiver. As a Phase 2 trial, this research measures zolpidem's effectiveness in an initial, smaller group of participants, providing an opportunity to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires that participants do not take certain medications, including beta-blockers, benzodiazepines, antiepileptic medications, melatonin, antihistamines, and antidepressants. If you are on any of these, you would need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have examined zolpidem's effects on sleep in children with Autism Spectrum Disorder (ASD). The results show that zolpidem usually causes mild side effects that resolve on their own, indicating these effects are generally minor and temporary.

The FDA has already approved zolpidem for treating sleep problems in adults, suggesting a degree of safety. However, while testing in children with ASD, the initial study phase indicates that more research is needed to fully understand its safety for this group.

Overall, zolpidem appears well-tolerated, but like any treatment, some side effects may occur. Prospective trial participants should discuss potential risks and benefits with a healthcare professional. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Zolpidem for sleep disturbances in children with autism because it offers a fresh approach compared to traditional therapies like behavioral interventions and melatonin supplements. Zolpidem works by targeting GABA receptors in the brain, which are linked to promoting sleep, potentially providing a more direct mechanism to address sleep issues. This medication, often used in adults for insomnia, might offer quicker and more consistent results, giving families a new hope for managing sleep challenges in autism.

What evidence suggests that zolpidem might be an effective treatment for sleep disturbances in children with autism?

Research has shown that zolpidem, a sleep medication, may help children with Autism Spectrum Disorder (ASD) sleep better. Zolpidem calms the brain, promoting sleep. In past studies, most children tolerated the medication well, though a rare case showed the opposite effect. In this trial, participants will receive either zolpidem followed by a placebo or a placebo followed by zolpidem to explore its potential benefits. While zolpidem is less commonly used than melatonin for sleep problems in autism, researchers aim to determine if it can effectively reduce sleep issues in children with ASD. ^{1 4 5 6 7}

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 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.

Inclusion Criteria

Meet DSM-5 criteria for Autism Spectrum Disorder (ASD) confirmed with ADI-R and ADOS-2

Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 80% or less

Willingness to provide additional saliva samples and participate in key study procedures

Exclusion Criteria

I am taking medications that interact with zolpidem.

History of hypersensitivity to zolpidem

I do not have active thoughts of suicide or a diagnosis of schizophrenia, schizoaffective, or psychotic disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Zolpidem or Placebo in a crossover design for 8 weeks, with each treatment lasting 4 weeks

8 weeks

Weekly visits for monitoring and dose adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Zolpidem

Trial Overview 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.

How Is the Trial Designed?

Group I: Zolpidem, then Placebo Experimental Treatment 2 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 Zolpidem Experimental Treatment 2 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.

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

About two-thirds of children with autism spectrum disorder (ASD) experience chronic insomnia, highlighting a significant issue in this population.

Effective strategies for improving sleep in children with ASD include sleep education, environmental modifications, behavioral interventions, and the use of melatonin, as outlined in a practice pathway developed by the Autism Treatment Network.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in Children with Autism Spectrum Disorder. Souders, MC., Zavodny, S., Eriksen, W., et al.[2022]

In a 14-week study involving 24 children with autism spectrum disorders, supplemental melatonin significantly improved sleep onset latency, showing effectiveness as early as the first week and maintaining benefits over several months.

The treatment was well tolerated and safe, leading to improvements not only in sleep but also in behavior and parenting stress, supporting the potential for larger randomized trials in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes. Malow, B., Adkins, KW., McGrew, SG., et al.[2022]

A pilot study involving 17 children with autism and insomnia showed that an 8-session cognitive behavioral treatment for childhood insomnia (CBT-CI) significantly improved both child and parent sleep, as well as reduced challenging behaviors like irritability and hyperactivity.

Parents reported that CBT-CI was helpful and suitable for their children, indicating that this treatment is feasible and promising for addressing insomnia in school-aged children with autism, warranting further research through randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral treatment of insomnia in school-aged children with autism spectrum disorder: A pilot feasibility study. McCrae, CS., Chan, WS., Curtis, AF., et al.[2020]

Melatonin was found to significantly improve sleep latency and duration in children, especially those with autism or other neurodevelopmental disorders, based on a review of 22 randomized controlled trials involving 1758 children.

Pharmacologic treatments like zolpidem and eszopiclone showed limited efficacy for sleep improvement in children with ADHD, with some adverse events reported, indicating that melatonin may be a safer and more effective option for managing sleep disorders in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic Treatments for Sleep Disorders in Children: A Systematic Review. McDonagh, MS., Holmes, R., Hsu, F.[2020]

In a study of 107 children with autism spectrum disorders, melatonin was found to be a safe and well-tolerated treatment for insomnia, with 25% of parents reporting that sleep was no longer a concern after treatment.

The majority of parents (60%) noted improved sleep with melatonin, and there were minimal side effects, such as mild morning sleepiness, with no increase in seizure activity among children with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melatonin for insomnia in children with autism spectrum disorders. Andersen, IM., Kaczmarska, J., McGrew, SG., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05540574

Trial of Zolpidem for Sleep in Children With Autism The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6313590/

Pharmacological Approach to Sleep Disturbances in Autism ... It was well tolerated in most of the participants, except one paradoxical response in a child [57].

3. withpower.com withpower.com/trial/phase-2-autism-spectrum-disorder-10-2022-30ba9

Zolpidem for Sleep Disturbances in Children with Autism In a 14-week study involving 24 children with autism spectrum disorders, supplemental melatonin significantly improved sleep onset latency, showing ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945724002612

Insomnia in children affected by autism spectrum disorder Recent data show that melatonin-based formulations are effective and safe for treating ASD-related insomnia both short and long term.

5. eurjther.com eurjther.com/index.php/home/article/view/1978

Current Pharmacological Treatment for Sleep Disorders in ... Melatonin, behavioral interventions, and parent education are the most effective treatments to improve sleep, relative to other pharmacological treatments.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468115/

Sleep Disorders in Children with Autism Spectrum Disorder Limited pediatric data suggest Zolpidem generally shows mild, self-limiting adverse events in children [198,199]. A randomized placebo-controlled crossover ...

7. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/t/NCT05540574.html

Trial of Zolpidem for Sleep in Children With Autism The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD).