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Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder

Paul Gringras1, Tali Nir2, John Breddy3

  • 1Children's Sleep Medicine, Evelina London Children's Hospital, Guy's and St Thomas', London.

Journal of the American Academy of Child and Adolescent Psychiatry
|November 4, 2017
PubMed

Insights

Pediatric prolonged-release melatonin minitablets (PedPRM) significantly improved total sleep time and reduced sleep latency in children with autism spectrum disorder (ASD) and related neurodevelopmental disorders. The treatment was found to be safe and well-tolerated, with high acceptability in this population.

Area of Science:

  • Pediatric Sleep Medicine
  • Neurodevelopmental Disorders
  • Pharmacology

Background:

  • Insomnia is a common challenge for children with autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), and neurogenetic disorders (NGD).
  • Standard behavioral interventions are often insufficient for managing sleep disturbances in these populations.
  • Novel therapeutic approaches are needed to address pediatric insomnia effectively.

Purpose of the Study:

  • To evaluate the efficacy and safety of pediatric-appropriate, prolonged-release melatonin minitablets (PedPRM) for treating insomnia in children and adolescents with ASD, with or without ADHD, and NGD.
  • To compare the effects of PedPRM against a placebo in improving sleep parameters.
  • To assess the tolerability and acceptability of the PedPRM formulation.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial involving 125 children and adolescents (aged 2-17.5 years).
  • Participants received either PedPRM (escalated from 2 mg to 5 mg) or placebo for 13 weeks.
  • Sleep was assessed using the Sleep and Nap Diary (SND) and Composite Sleep Disturbance Index (CSDI), with total sleep time (TST) as the primary endpoint.

Main Results:

  • PedPRM significantly increased average nighttime total sleep time by 57.5 minutes compared to 9.14 minutes for placebo (p = .034).
  • Sleep latency decreased by an average of 39.6 minutes with PedPRM versus 12.5 minutes with placebo (p = .011).
  • A significantly higher proportion of participants on PedPRM achieved clinically meaningful improvements in TST and/or SL (68.9% vs. 39.3%, p = .001).

Conclusions:

  • Pediatric prolonged-release melatonin minitablets (PedPRM) are effective and safe for treating insomnia in children with ASD, ADHD, and NGD.
  • The formulation demonstrated high acceptability, even in a population with known swallowing difficulties.
  • PedPRM offers a promising therapeutic option for pediatric insomnia associated with neurodevelopmental disorders.
Abstract

Keywords:
autismmelatoninneurogeneticpediatricsleep

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