An open-label study of controlled-release melatonin in treatment of sleep disorders in children with autism

Area of Science:

• Pediatric Neurology
• Sleep Medicine
• Autism Spectrum Disorder Research

Background:

• Children with autism spectrum disorder (ASD) frequently experience chronic sleep disorders.
• Problematic sleep patterns are common in autistic children compared to neurotypical controls.
• Existing treatments for sleep issues in ASD may have limitations or side effects.

Purpose of the Study:

• To evaluate the long-term effectiveness and tolerability of controlled-release melatonin in children with autism.
• To assess the impact of melatonin treatment on sleep patterns using objective and subjective measures.
• To determine if treatment gains are maintained after discontinuation and upon readministration.

Main Methods:

• Open-label evaluation of controlled-release melatonin in 25 children (aged 2.6-9.6 years) with autism without comorbidities.
• Sleep patterns assessed via Children's Sleep Habits Questionnaire (CSHQ) and sleep diaries at baseline, 1-3-6 months of treatment, and 1 month post-discontinuation.
• Long-term follow-up at 12 and 24 months to assess sustained effectiveness.

Main Results:

• Autistic children exhibited more problematic sleep patterns at baseline compared to controls.
• Controlled-release melatonin treatment led to significant improvements in sleep patterns for all participants.
• Sleep improvements were maintained at 12 and 24-month follow-ups, with gains returning after readministration following a temporary decline post-discontinuation.
• No adverse side effects were reported during the study.

Conclusions:

• Controlled-release melatonin is an effective treatment for chronic sleep disorders in children with autism.
• The treatment is well-tolerated, with sustained benefits over long-term use.
• Melatonin offers a promising therapeutic option for improving sleep quality in this population.