REST ASSURED: A RANDOMIZED CONTROLLED TRIAL COMPARING MELATONIN AND SLEEP HYGIENE THERAPY FOR INSOMNIA IN CHILDREN WITH DEVELOPMENTAL DELAY

Abstract

Background:
Pediatric insomnia is highly prevalent among children with neurodevelopmental disorders (NDDs) such as autism spectrum disorder, intellectual disabilities, and ADHD, exacerbating cognitive, emotional, and behavioral challenges. Although melatonin supplementation and behavioral sleep hygiene therapy are commonly used interventions, direct comparisons of their effectiveness in children with developmental delays are limited.

Objective:
To evaluate and compare the efficacy and safety of melatonin supplementation and structured sleep hygiene therapy in treating pediatric insomnia among children with developmental delays.

Methods:
This randomized, parallel-group controlled trial enrolled 120 children aged 2–12 years diagnosed with developmental delay and insomnia. Participants were randomized 1:1 to receive either nightly melatonin supplementation or individualized sleep hygiene therapy for eight weeks. The primary outcome was sleep onset latency (SOL), measured by actigraphy and sleep diaries. Secondary outcomes included sleep duration, frequency of nighttime awakenings, safety profiles, and caregiver satisfaction. Statistical analyses were performed using independent t-tests and mixed-model repeated measures ANOVA.

Results:
Both groups demonstrated significant within-group improvements in sleep parameters. Median sleep onset latency decreased from 60–62 minutes at baseline to approximately 45–47 minutes post-intervention in both groups. Total sleep time increased by approximately one hour in both groups. Nighttime awakenings decreased from two to one episode nightly. Although melatonin showed a trend toward greater reduction in sleep onset latency compared to sleep hygiene (p = 0.07), and improvement in sleep duration (p = 0.09), between-group differences did not reach statistical significance. Participants experiencing mild-to-moderate side effects exhibited greater reductions in SOL (p = 0.04). Caregiver satisfaction was significantly higher in the melatonin group (p = 0.023). Side effects were generally mild to moderate.

Conclusion:
Both melatonin supplementation and structured sleep hygiene therapy effectively improved sleep onset latency, sleep duration, and reduced nighttime awakenings in children with developmental delays. While melatonin offered faster symptomatic relief and higher caregiver satisfaction, sleep hygiene therapy remains a sustainable, non-pharmacological first-line strategy. Future long-term studies are warranted to evaluate the durability and safety of these interventions and to guide individualized pediatric insomnia management.