Suvorexant for Sleep Issues 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, Antiepileptics, others

Disqualifiers: Schizophrenia, Seizure disorder, Severe hepatic insufficiency, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

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 explores how suvorexant, a medication designed to aid in falling and staying asleep, can improve sleep for children and teens with Autism Spectrum Disorder (ASD). Researchers are testing whether suvorexant can alleviate sleep troubles in these young individuals by having participants try both the medication and a placebo (a pill with no active ingredients) over eight weeks. Children aged 13 to 17 with ASD who experience significant sleep issues, such as difficulty falling or staying asleep, may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

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 there any evidence suggesting that suvorexant is likely to be safe for children with autism?

Research has shown that suvorexant is usually well-tolerated by children and teenagers. Some studies have identified side effects such as sleepiness, fatigue, unusual dreams, and dry mouth, which are common with sleep medications. Notably, the FDA has already approved suvorexant for treating insomnia in adults, indicating its general safety. Although more research is needed to confirm its safety for children with autism, current evidence is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sleep issues in children with autism?

Unlike standard treatments for sleep issues in children with autism, which often include melatonin or behavioral therapies, Suvorexant acts on a different pathway. Suvorexant is unique because it targets orexin receptors in the brain, which play a key role in regulating wakefulness and sleep. This mechanism of action could offer a new way to help children with autism fall asleep faster and stay asleep longer. Researchers are excited about Suvorexant because it may provide an effective alternative for those who have not responded well to current treatments.

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

Research has shown that suvorexant can help with sleep problems. In studies with adults, it helped people fall asleep faster and stay asleep longer. For teenagers, taking suvorexant significantly improved sleep quality. Suvorexant works by blocking certain brain signals that keep individuals awake, helping the body relax and fall asleep. It has already been approved for treating insomnia, proving effective in improving sleep issues. This trial will evaluate suvorexant as a promising option for children with Autism Spectrum Disorder (ASD) who have trouble sleeping. Participants in this trial will receive suvorexant and a placebo in different sequences to assess its effectiveness. ^{1 6 7 8 9}

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

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

I am between 13 and 17 years old.

Stable medications for at least 4 weeks

Exclusion Criteria

I have tried suvorexant with no success.

History of narcolepsy

I am currently taking prescribed medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Suvorexant or Placebo for a 4-week period, followed by crossover to the alternate treatment for another 4 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Suvorexant

Trial Overview 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.

How Is the Trial Designed?

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

Suvorexant is already approved in United States, Japan for the following indications:

Approved in United States as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Approved in Japan as Belsomra for:

• Insomnia characterized by difficulties with sleep onset and/or sleep maintenance

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

This trial will assess the efficacy of suvorexant, an FDA-approved sleep aid, in reducing nighttime wakefulness and delirium in 120 older cardiac surgery patients in the ICU.

The study aims to determine if suvorexant can improve sleep quality and reduce the incidence of postoperative delirium, which is important for recovery in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial evaluating the effects of the orexin receptor antagonist suvorexant on sleep architecture and delirium in the intensive care unit. Azimaraghi, O., Hammer, M., Santer, P., et al.[2021]

Suvorexant is the first orexin receptor antagonist approved for treating insomnia, showing significant efficacy in reducing sleep latency and improving sleep maintenance in both non-elderly and elderly patients, based on two Phase 3 clinical trials with a total duration of 3 months.

The most common side effect was somnolence, with a number needed to harm (NNH) of 13 for higher doses, indicating that while suvorexant is effective, it does carry some risk of next-day sedation, leading to a recommended dose range of 10-20 mg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant for insomnia: a systematic review of the efficacy and safety profile for this newly approved hypnotic - what is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Citrome, L.[2018]

A reliable liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed to measure suvorexant levels in human plasma, demonstrating high precision and accuracy across a wide concentration range (1-1000 ng/mL).

The method has been validated for stability and can support clinical studies for suvorexant, showing that plasma samples remain stable for up to 25 months at -20°C, which is crucial for long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of suvorexant in human plasma using 96-well liquid-liquid extraction and HPLC with tandem mass spectrometric detection. Breidinger, SA., Simpson, RC., Mangin, E., et al.[2019]

Suvorexant, the first orexin receptor antagonist approved by the FDA for treating insomnia, has been shown to effectively induce and maintain sleep in adult and elderly patients over treatment periods of up to 12 months.

While the FDA approved doses of 5, 10, 15, and 20 mg due to concerns about safety and next-morning effects like somnolence and unusual behaviors, suvorexant represents a novel approach to insomnia treatment, potentially leading to new therapies targeting orexin receptors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant for the treatment of insomnia. Jacobson, LH., Callander, GE., Hoyer, D.[2015]

Suvorexant (Belsomra®) is a new sleep medication that works by blocking orexin neurons, leading to a rapid onset of sleep, and is effective at a prescribed dose of 10 mg before bedtime.

A highly sensitive urine assay was developed to accurately identify and quantify suvorexant, demonstrating excellent precision and stability, which is crucial for monitoring its use due to potential misuse and interactions with other sedatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Suvorexant in Urine Using Liquid Chromatography-Quadrupole/Time-of-Flight Mass Spectrometry (LC-Q/TOF-MS). Sullinger, S., Bryand, K., Kerrigan, S.[2017]

Suvorexant, an orexin receptor antagonist, was generally well tolerated in a Phase 1 trial with 40 healthy men over 14 days, supporting its safety for use in treating insomnia.

The trial showed that higher doses (40 mg and above) resulted in 100% of subjects reporting adverse events, with common side effects including somnolence, fatigue, and headache, indicating a dose-dependent increase in side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, and Pharmacokinetics of Suvorexant: A Randomized Rising-Dose Trial in Healthy Men. Yee, KL., McCrea, J., Panebianco, D., et al.[2019]

Suvorexant, a new medication for insomnia, is generally considered safe and well tolerated in most patients.

However, there is a rare but significant adverse effect associated with suvorexant in patients with Parkinson's disease, highlighting the need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant-Induced Dream Enactment Behavior in Parkinson Disease: A Case Report. Tabata, H., Kuriyama, A., Yamao, F., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05546554

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

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10038945/

Dual orexin receptor antagonists for insomnia in youth with ... In clinical trials of neurotypical adults with insomnia, suvorexant was associated with significant improvements in subjective time-to-sleep onset, total sleep ...

3. med.stanford.edu med.stanford.edu/mosslab/research/clinicaltrial?ctid=NCT05546554&conditionId=&serviceLineId=&condition=&alpha=t

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

4. researchgate.net researchgate.net/publication/317016657_Suvorexant_for_the_Treatment_of_Insomnia_in_Adolescents

Suvorexant for the Treatment of Insomnia in Adolescents This study found significant improvement in subjective sleep quality in those adolescents who took suvorexant 20 mg/day and completed the study ...

5. withpower.com withpower.com/trial/phase-2-autistic-disorder-10-2022-6605f

Suvorexant for Sleep Issues in Children with Autism Suvorexant is the first orexin receptor antagonist approved for treating insomnia, showing significant efficacy in reducing sleep latency and improving sleep ...

6. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/t/NCT05546554.html

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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10755553/

Management of sleep disorders in autism spectrum disorder ... Efficacy and safety of melatonin treatment in children with autism spectrum disorder and attention-deficit/hyperactivity disorder–a review of the literature.

8. link.springer.com link.springer.com/article/10.1007/s00787-021-01883-7

Dual orexin receptor antagonists for insomnia in youth with ... Participants reported elevated rates of somnolence, fatigue, abnormal dreams, and dry mouth [15]. These data suggest that suvorexant may be safe ...

9. mdpi.com mdpi.com/2076-3425/15/9/983

Sleep Disorders in Children with Autism Spectrum Disorder DORAs such as suvorexant, lemborexant, and daridorexant promote sleep by blocking orexin receptors, thereby dampening arousal and facilitating sleep onset and ...