Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes

Area of Science:

• Pediatric Neurology
• Sleep Medicine
• Autism Spectrum Disorders Research

Background:

• Sleep onset insomnia is a common challenge for children with autism spectrum disorders (ASD).
• Limited research exists on the efficacy and safety of supplemental melatonin for insomnia in this population.
• Previous studies suggest potential benefits of melatonin for sleep disturbances in ASD.

Purpose of the Study:

• To assess the dose-response, tolerability, and safety of supplemental melatonin in children with ASD experiencing sleep onset insomnia.
• To evaluate the feasibility of collecting actigraphy data and the ability of outcome measures to detect changes during a 14-week intervention.
• To determine the effectiveness of melatonin in improving sleep latency, behavior, and parenting stress.

Main Methods:

• An open-label, dose-escalation study involving 24 children with ASD, free of psychotropic medications.
• Participants received supplemental melatonin with dosages adjusted over a 14-week intervention period.
• Sleep latency was measured using actigraphy, alongside assessments of behavior and parenting stress.

Main Results:

• Supplemental melatonin demonstrated efficacy in improving sleep latency in most children, particularly at 1 mg and 3 mg dosages.
• Positive effects on sleep latency were observed as early as week 1 and were maintained over several months.
• The intervention was well-tolerated and safe, with improvements noted in sleep, behavior, and reduced parenting stress.

Conclusions:

• Supplemental melatonin is a promising, safe, and well-tolerated treatment for sleep onset insomnia in children with ASD.
• Melatonin shows early and sustained effectiveness in improving sleep latency and associated behavioral outcomes.
• Findings support the planning of larger randomized controlled trials to further validate melatonin's role in managing insomnia in ASD.