Melatonin Improves Sleep Outcomes in Children With Neuropsychiatric Disorders

Exogenous melatonin reduces sleep onset latency and improves sleep efficiency and duration in pediatric patients with neurological and psychiatric conditions, according to findings published in Sleep Medicine Reviews.

Although melatonin is frequently prescribed to children with neurodevelopmental and psychiatric disorders, there has been limited evidence to guide the optimal dosing and timing of administration. To address this gap, researchers conducted a meta-analysis to determine how dosage, administration time, and treatment duration influence melatonin’s efficacy in improving sleep outcomes.

The researchers completed a comprehensive search of PubMed, Embase, Cochrane, and Scopus databases for clinical trials published up to April 30, 2024. Eligible studies included prepubertal children with primary sleep disorders or sleep disturbances and comorbid neurological or psychiatric conditions. Interventions were limited to oral melatonin compared with placebo.

A total of 21 studies reporting on 22 samples were included in the final analysis, representing children with autism spectrum disorder, attention-deficit/hyperactivity disorder, epilepsy, and other neurodevelopmental disorders. Treatment doses ranged from 1 to 9 mg/day, typically administered within 3 hours of bedtime, and treatment duration lasted 3 to 12 weeks. Primary outcomes included changes in sleep onset latency, total sleep time, sleep efficiency, and wake after sleep onset.

Melatonin administration significantly reduced sleep onset latency compared with placebo (mean difference, -22.76 minutes; 95% CI, -28.56 to -16.96; P <.001). There were also improvements in total sleep time (mean difference, 38.65 minutes; 95% CI, 24.19-53.10; P <.001) and sleep efficiency (mean difference, 5.52%; 95% CI, 2.75%–8.29%; P <.001). However, reductions in wake after sleep onset did not reach statistical significance (mean difference, -14.10 minutes; 95% CI, -28.80 to 0.60; P =.060).

According to dose-response analyses, melatonin’s greatest benefits for total sleep time and sleep efficiency occurred with doses between 2 and 4 mg/day, while sleep onset latency reduction was most pronounced at 3 to 5 mg/day. Earlier administration at approximately 3 hours before bedtime was linked to greater decreases in sleep onset latency.

Further, longer treatment durations enhanced both total sleep time and sleep efficiency, highlighting the value of sustained therapy. Compared with children without neurodevelopmental disorders, children with neurodevelopmental disorders experienced greater reductions in sleep onset latency with melatonin treatment. In addition, dose-response curves indicated more linear benefits in children with neurodevelopmental disorders, with increasing doses up to 5 mg/day.

Study limitations include protocol heterogeneity and a small number of studies included.

“These findings provide new insight on how to improve sleep in neurological and psychiatric pediatric patients through the administration of exogenous melatonin,” the study authors concluded.

Disclosures: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.