1. In this randomized controlled trial, sleep onset latency was significantly decreased in children with autism spectrum disorder who received melatonin compared to those who received placebo.
2. Furthermore, there were no serious adverse events or deaths associated with melatonin. The most common adverse events were infections, nervous system disorders, and pharyngitis.
Evidence Rating Level: 1 (Excellent)
Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can affect children’s social behaviours, cognitive aptitudes, and sleep quality. Exogenous melatonin is a known pharmacotherapy that is used to help improve sleep quality and has been studied in children with ASD. However, there has been limited evidence regarding the efficacy of this treatment. Therefore, the objective of this study was to investigate the safety and efficacy of exogenous melatonin for addressing sleep problems in children with ASD.
This randomized controlled trial conducted in Japan included outpatient children aged 6-15 years with ASD. Patients were included if they had a sleep onset latency (SOL) equal to or greater than 30 minutes and were cooperative for sleep hygiene interventions. Patients were excluded if they had severe intellectual disabilities, previous melatonin treatment, or breathing-related sleep disorders. Participants (n=229) were randomized to receive either 1-mg of melatonin, 4-mg of melatonin, or placebo 45 minutes before bedtime. SOL was measured by parents and caregivers using a sleep diary. Sleep actigraphy was also utilized for objective sleep measures, and adverse events were recorded. The primary outcome was the change in the median SOL from baseline.
Results demonstrated a significant reduction in SOL in both the 1-mg and 4-mg melatonin groups compared to the placebo group. Sub-group analyses in height, age, and weight were all significant for improvements in SOL in both 1-mg and 4-mg groups versus the placebo except of females in the 1-mg group. There were no serious adverse events or deaths, and the most common adverse events included infections, neurological disorders, and pharyngitis. However, a drawback of the study was the narrow inclusion criteria, which limited the generalizability of the results to children with ASD outside of the included age range. Nonetheless, this study identified melatonin as an effective intervention to improve sleep quality in children with ASD.
Click to read the study in Journal of Autism and Developmental Disorders
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