Journal
JOURNAL OF THE AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY
Volume 60, Issue 2, Pages 252-+Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jaac.2019.12.007
Keywords
autism; melatonin; sleep
Categories
Funding
- Neurim Pharmaceuticals
- Clinical and Translational Sciences Awards (CTSA) Program award from the National Center for Advancing Translational Sciences [UL1 TR002243]
Ask authors/readers for more resources
The study demonstrates that nightly PedPRM at optimal dose is safe and effective for long-term treatment of insomnia in children and adolescents with autism spectrum disorder. The treatment maintains improvements in sleep and quality of life without detrimental effects on growth and pubertal development. Withdrawal effects and safety issues related to the drug were not observed.
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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available