Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver’s Quality of Life

Carmen M. Schroder, Beth A. Malow, Athanasios Maras, Raun D. Melmed, Robert L. Findling, John Breddy, Tali Nir, Shiri Shahmoon, Nava Zisapel, Paul Gringras

Research output: Contribution to journalArticle

Abstract

A randomized, 13-weeks, placebo-controlled double-blind study in 125 subjects aged 2–17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia demonstrated efficacy and safety of easily-swallowed prolonged-release melatonin mini-tablets (PedPRM; 2–5 mg) in improving sleep duration and onset. Treatment effects on child behavior and caregiver’s quality of life were evaluated. PedPRM treatment resulted in significant improvement in externalizing but not internalizing behavior (Strengths and Difficulties questionnaire; SDQ) compared to placebo (p = 0.021) with clinically-relevant improvements in 53.7% of PedPRM-treated versus 27.6% of placebo-treated subjects (p = 0.008). Caregivers’ quality of life also improved with PedPRM versus placebo (p = 0.010) and correlated with the change in total SDQ (p = 0.0005). PedPRM alleviates insomnia-related difficulties, particularly externalizing behavior in the children, subsequently improving caregivers’ quality of life.

Original languageEnglish (US)
Pages (from-to)3218-3230
Number of pages13
JournalJournal of Autism and Developmental Disorders
Volume49
Issue number8
DOIs
StatePublished - Aug 15 2019

Keywords

  • Autism
  • Behavior
  • Children (pediatric)
  • Prolonged-release melatonin
  • Sleep

ASJC Scopus subject areas

  • Developmental and Educational Psychology

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