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Pediatric prolonged-release melatonin for insomnia in children and adolescents with autism spectrum disorders

Carmen M Schroder1, Tobias Banaschewski2, Joaquin Fuentes3

  • 1Department of Child and Adolescent Psychiatry & Excellence Centre for Autism and Neurodevelopmental Disorders STRAS&ND, Strasbourg University Hospitals & University of Strasbourg Medical School, 67000 Strasbourg, France; CNRS UPR 3212, Institute for Cellular and Integrative Neurosciences; Sleep Disorders Center& International Research Center for ChronoSomnology, Strasbourg, France.

Expert Opinion on Pharmacotherapy
|July 27, 2021
PubMed

Insights

Pediatric-appropriate prolonged-release melatonin (PedPRM) effectively treats insomnia in children with Autism Spectrum Disorder (ASD), improving sleep and behavior. This formulation is well-accepted and has a favorable long-term safety profile.

Area of Science:

  • Pediatric sleep medicine
  • Autism Spectrum Disorder (ASD) research
  • Pharmacology of melatonin

Background:

  • Insomnia is a prevalent issue in children and adolescents diagnosed with Autism Spectrum Disorder (ASD).
  • There is a need for effective and safe pharmacological interventions for insomnia in this population.
  • Pediatric-appropriate prolonged-release melatonin (PedPRM) is the first licensed medication for insomnia in children with ASD.

Purpose of the Study:

  • To review the efficacy and safety of PedPRM in clinical trials for treating insomnia in children and adolescents with ASD.
  • To propose a decision-making algorithm for optimizing PedPRM treatment outcomes.
  • To evaluate the impact of PedPRM on sleep, behavior, and caregiver quality of life.

Main Methods:

  • Literature search focusing on clinical trials of PedPRM in pediatric ASD population.
  • Analysis of efficacy data regarding sleep onset, duration, and consolidation.
  • Assessment of safety profiles, including adverse events and developmental parameters.

Main Results:

  • PedPRM significantly improves sleep onset, duration, and consolidation in children with ASD.
  • Improvements in daytime externalizing behaviors and enhanced caregiver quality of life were observed.
  • The formulation is well-accepted due to its sensory characteristics; common adverse events include fatigue and somnolence, with no impact on development or withdrawal effects.

Conclusions:

  • PedPRM demonstrates long-term efficacy, safety, and acceptance for treating insomnia in children and adolescents with ASD.
  • The medication can potentially mitigate the long-term consequences of chronic insomnia in this vulnerable population.
  • A structured dosing approach, considering individual response and metabolism, can optimize treatment success.

Keywords:
Prolonged-release melatoninadolescentautism spectrum disorderchildinsomnia

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