A recent study examined the impact of a nightly dose of pediatric prolonged-release melatonin on sleep disturbances in children with autism spectrum disorder.
A nightly dose of pediatric prolonged-release melatonin (PedPRM) administered to children with autism spectrum disorder (ASD) moderated sleep disturbances, a trial in 80 children and adolescents from 2 to 17 years of age with ASD found. Participants had experienced at least 3 months of impaired sleep, defined as sleeping continuously for fewer than 6 hours or taking more than a half hour to fall asleep most nights. Before entering the study, all participants had tried standardized sleep hygiene and behavioral interventions.
The study comprised a 2-week placebo run-in followed by a randomized trial during which participants in the intervention group received a nightly dose of PedPRM (2 mg, 5 mg, or 10 mg) 30 to 60 minutes before bedtime for up to 104 weeks (most children were treated for 2 years). This was followed by a 2-week placebo period to assess withdrawal effects.
PedPRM was associated with improvements in participants’ sleep and caregiver satisfaction with their child’s sleep patterns, quality of sleep, and quality of life, benefits that were maintained throughout the treatment period, though they declined somewhat during the placebo phase. The most common treatment-related adverse events were fatigue (experienced by 6.3% of participants), somnolence (6.3%), and mood swings (4.2%). PedPRM was not associated with any detrimental effects on growth or pubertal development (Malow, BA et al. J Am Acad Child Adolesc Psychiatry. 2020. Epub ahead of print).
Thoughts from Dr. Farber
Melatonin has been a lifesaver for many parents, markedly improving quality of life, especially those whose children have developmental disabilities. Previously, at times I had been forced to use chloral hydrate. This study, while not exploring some possible side effects (eg, lab abnormalities), does support that melatonin can be used safely, in high doses, for at least two years.