Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 29096777 · doi:10.1016/j.jaac.2017.09.414
What was done
A double-blind, randomized controlled trial evaluated the efficacy and safety of pediatric prolonged-release melatonin minitablets (PedPRM, 2 mg titrated to 5 mg) versus placebo over 13 weeks in 125 children and adolescents (aged 2–17.5 years; 96.8% with autism spectrum disorder [ASD], 3.2% with Smith-Magenis syndrome) whose insomnia failed to improve with behavioral intervention alone. Outcomes were measured via the caregiver-completed Sleep and Nap Diary (SND) and Composite Sleep Disturbance Index (CSDI), with the primary endpoint being SND-reported total sleep time (TST) at week 13.
What was found
After 13 weeks, participants receiving PedPRM had an average increase in TST of 57.5 minutes compared to 9.14 minutes with placebo (adjusted mean treatment difference: 32.43 minutes; p = .034). Sleep latency decreased by an average of 39.6 minutes with PedPRM versus 12.5 minutes with placebo (adjusted mean treatment difference: -25.30 minutes; p = .011) without altering wakeup time. Clinically meaningful response rates were significantly higher with PedPRM (68.9% vs. 39.3%; p = .001; NNT = 3.38). Overall sleep disturbance tended to decrease on CSDI. PedPRM was generally safe, with somnolence reported more frequently than with placebo.
Why it matters
This study provides randomized evidence that a child-appropriate prolonged-release melatonin formulation effectively increases sleep duration and reduces sleep onset latency in pediatric patients with ASD and treatment-resistant insomnia.
Limits
The trial relied entirely on caregiver-reported sleep diaries rather than objective measures such as actigraphy or polysomnography. The sample size was relatively small (n = 125), neurogenetic disorders other than ASD were minimally represented (3.2%), and follow-up was limited to 13 weeks, leaving long-term efficacy and safety unassessed.
Cited by
- supports Clinical studies show melatonin at doses of 5 mg to 7 mg is effective for improving sleep in children with autism spectrum disorder.