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Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder
Beth A Malow1, Robert L Findling2, Carmen M Schroder3
1Sleep Division, Vanderbilt University Medical Center, Nashville, Tennessee.
Insights
Long-term use of pediatric prolonged-release melatonin (PedPRM) safely improved sleep in children with autism spectrum disorder without impacting growth or puberty. Improvements were maintained after treatment cessation.
Area of Science:
- Pediatric sleep medicine
- Neurodevelopmental disorders
- Pharmacology
Background:
- Insomnia is prevalent in children with autism spectrum disorder (ASD).
- Pediatric prolonged-release melatonin (PedPRM) has shown short-term efficacy for ASD-related insomnia.
- Long-term safety and efficacy data are crucial for treatment decisions.
Purpose of the Study:
- To evaluate the long-term effects of PedPRM on sleep, growth, BMI, and pubertal development in children with ASD.
- To assess the maintenance of sleep improvements and potential withdrawal effects after long-term PedPRM treatment.
- To determine the overall safety profile of extended PedPRM use in this population.
Main Methods:
- A 104-week open-label extension study involving 80 children and adolescents (2-17.5 years) with ASD and insomnia.
- Participants received 2 mg, 5 mg, or 10 mg of PedPRM nightly.
- A 2-week placebo period followed treatment to assess withdrawal effects; growth and pubertal status were monitored.
Main Results:
- Sleep disturbances and caregiver satisfaction significantly improved and were maintained throughout 104 weeks (p < .001).
- Measures declined during withdrawal but remained better than baseline.
- No detrimental effects on weight, height, BMI, or pubertal development (Tanner stage) were observed. Common adverse events included fatigue and somnolence.
Conclusions:
- Nightly PedPRM (2-10 mg) is safe and effective for long-term insomnia treatment in children and adolescents with ASD.
- No negative impact on growth or pubertal development was detected.
- No significant safety concerns or withdrawal issues were identified with long-term PedPRM use or discontinuation.
Objective:
A recent 3-month double-blind, placebo-controlled study demonstrated efficacy and safety of pediatric prolonged-release melatonin (PedPRM) for insomnia in children with autism spectrum disorder. This study examined the long-term effects of PedPRM treatment on sleep, growth, body mass index, and pubertal development.
Method:
Eighty children and adolescents (2-17.5 years of age; 96% with autism spectrum disorder) who completed the double-blind, placebo-controlled trial were given 2 mg, 5 mg, or 10 mg PedPRM nightly up to 104 weeks, followed by a 2-week placebo period to assess withdrawal effects.
Results:
Improvements in child sleep disturbance and caregiver satisfaction with child sleep patterns, quality of sleep, and quality of life were maintained throughout the 104-week treatment period (p < .001 versus baseline for all). During the 2-week withdrawal placebo period, measures declined compared with the treatment period but were still improved compared with baseline. PedPRM was generally safe; the most frequent treatment-related adverse events were fatigue (6.3%), somnolence (6.3%), and mood swings (4.2%). Changes in mean weight, height, body mass index, and pubertal status (Tanner staging done by a physician) were within normal ranges for age with no evidence of delay in body mass index or pubertal development.
Conclusion:
Nightly PedPRM at optimal dose (2, 5, or 10 mg nightly) is safe and effective for long-term treatment in children and adolescents with autism spectrum disorder and insomnia. There were no observed detrimental effects on children's growth and pubertal development and no withdrawal or safety issues related to the use or discontinuation of the drug.
Clinical Trial Registration Information:
Efficacy and Safety of Circadin in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities; https://clinicaltrials.gov/; NCT01906866.
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