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Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior

Carmen M Schroder1,2, Beth A Malow3, Athanasios Maras4

  • 1Department of Child and Adolescent Psychiatry & CIRCSom, Strasbourg University Hospital, Strasbourg, France.

Journal of Autism and Developmental Disorders
|May 13, 2019
PubMed

Insights

Prolonged-release melatonin mini-tablets (PedPRM) effectively improved sleep in children with Autism Spectrum Disorder or Smith-Magenis syndrome. This treatment also reduced externalizing behaviors and enhanced caregiver quality of life.

Area of Science:

  • Pediatric Sleep Medicine
  • Neurodevelopmental Disorders
  • Pharmacology

Background:

  • Insomnia is a common challenge in children with Autism Spectrum Disorder (ASD) and Smith-Magenis syndrome (SMS).
  • Existing treatments for sleep disturbances in these populations have limitations.
  • Melatonin is a hormone that regulates sleep-wake cycles.

Purpose of the Study:

  • To evaluate the efficacy and safety of prolonged-release melatonin mini-tablets (PedPRM) in children with ASD or SMS and insomnia.
  • To assess the impact of PedPRM on child behavior and caregiver quality of life.

Main Methods:

  • A 13-week, randomized, double-blind, placebo-controlled study.
  • 125 subjects aged 2-17.5 years with ASD or SMS and insomnia participated.
  • Participants received either PedPRM (2-5 mg) or placebo.

Main Results:

  • PedPRM significantly improved sleep duration and onset compared to placebo.
  • A significant improvement in externalizing behaviors (Strengths and Difficulties Questionnaire) was observed with PedPRM (p=0.021).
  • Caregiver quality of life also significantly improved with PedPRM treatment (p=0.010).

Conclusions:

  • Easily-swallowed prolonged-release melatonin mini-tablets (PedPRM) are effective and safe for treating insomnia in children with ASD or SMS.
  • PedPRM positively impacts child behavior, specifically reducing externalizing behaviors.
  • Improved sleep and behavior in children lead to enhanced quality of life for their caregivers.

Keywords:
AutismBehaviorChildren (pediatric)Prolonged-release melatoninSleep

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