Comparison of Efficacy and Safety of Melatonin in Improving Total Duration of Night-Time Sleep In Children with Neurodevelopmental Disorders: A Placebo Controlled Study

Abstract

Background: Poor sleep is known to have adverse impact on a child's attention, memory and learning behaviors. Inappropriate sleep is also linked to affect a child's non-verbal intelligence and communication. Moreover, insufficient sleep is also known to impact social skills among children. Objective: To compare the efficacy and safety of melatonin and placebo in improving total duration of night-time sleep in children with neurodevelopmental disorders (NDDs). Methods: This placebo controlled randomized trial was conducted at the Department of Pediatric Neurology, The Children's Hospital and Institute of Child Health, Multan from January 2021 to June 2021. A total of 160 children (80 in melatonin group and 80 in placebo group) aged 3-12 years with NDDs having sleep problems were enrolled. Oral melatonin was started as 1mg/day while melatonin was advised to be administered 45 minutes prior to child's usual bedtime. Parents were asked to follow up at 4-week interval. Final outcome in shape of total sleep time according to sleep diaries was recorded at 12 week time. Results: Mean night sleep time at the time of enrollment was calculated to be 501+83 minutes. There was a significant improvement in total sleep time with the use of melatonin as total sleep time increased from 494+78 minutes at baseline to 555+94 at 12 weeks (p<0.0001). In comparison to placebo, melatonin also proved to significantly increased the total sleep time duration at night (555+94 vs. 528+81, p=0.0340). No significant difference was noted in terms of adverse events in between study groups (p>0.05). Conclusion: Melatonin was found to improve total sleep time significantly during the course of this study among children with NDDs having sleep problems. No major side effects of melatonin were reported among children with NDDs having sleep problems.