Related Experiment Video
Updated: Dec 9, 2025
Author Spotlight: Overcoming Challenges in Drosophila Sleep Measurement Using DAM System
Published on: October 20, 2023
Long-term melatonin treatment for the sleep problems and aberrant behaviors of children with neurodevelopmental
Kotaro Yuge1, Shinichiro Nagamitsu2, Yuko Ishikawa3
1Department of Pediatrics and Child Health, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, 830-0011, Japan. yugekotaro@med.kurume-u.ac.jp.
Insights
This study found that long-term melatonin treatment significantly improved sleep onset latency and behavioral issues in children with neurodevelopmental disorders (NDDs). Melatonin treatment, combined with sleep hygiene, offers clinical benefits and enhances well-being in these children.
Area of Science:
- Pediatric Neurology
- Sleep Medicine
- Neurodevelopmental Disorders
Background:
- Limited clinical evidence exists on the long-term efficacy and safety of melatonin for sleep problems in children with neurodevelopmental disorders (NDDs).
- Adequate sleep hygiene interventions are crucial but require complementary treatments for persistent sleep issues in NDD populations.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of melatonin treatment for sleep problems in children with NDDs.
- To assess the impact of melatonin on sleep onset latency (SOL), aberrant behaviors, and overall well-being in pediatric NDD patients.
Main Methods:
- A 26-week, multicenter, open-label, phase III clinical trial involving 99 children (6-15 years) with NDDs and sleep problems.
- Children received 1, 2, or 4 mg of melatonin granules orally, with sleep status, aberrant behaviors (Aberrant Behavior Check List-Japanese version), and safety monitored.
- Primary endpoint was the change in sleep onset latency (SOL) during the initial medication phase.
Main Results:
- Melatonin significantly shortened sleep onset latency (SOL) from baseline (mean reduction of 36.7 min; P < 0.0001), with effects persisting throughout the study.
- Significant improvements were observed in temper upon wakening, sleepiness after awakening, stereotypic behavior, irritability, hyperactivity, and inappropriate speech.
- No treatment-emergent adverse events occurred after 16 weeks, and neurodevelopmental disorders did not deteriorate during the follow-up period.
Conclusions:
- Long-term melatonin treatment, alongside sleep hygiene, demonstrates significant clinical benefits for children with NDDs.
- Melatonin administration may improve sleep quality and reduce behavioral disturbances, contributing to enhanced well-being in pediatric NDD populations.
- The study supports the safety and efficacy of melatonin as an adjunct therapy for sleep problems in children with neurodevelopmental disorders.
Background:
Clinical evidence is required about the long-term efficacy and safety of melatonin treatment for sleep problems in children with neurodevelopmental disorders (NDDs) who underwent adequate sleep hygiene interventions.
Methods:
We conducted a 26-week, multicenter, collaborative, uncontrolled, open-label, phase III clinical trial of melatonin granules in children 6 to 15 years of age who had NDDs and sleep problems. The study consisted of the 2-week screening phase, the 26-week medication phases I and II, and the 2-week follow-up phase. Children received 1, 2, or 4 mg melatonin granules orally in the medication phases. Variables of sleep status including sleep onset latency (SOL), aberrant behaviors listed on the Aberrant Behavior Check List-Japanese version (ABC-J), and safety were examined. The primary endpoint was SOL in the medication phase I.
Results:
Between June 2016 and July 2018, 99 children (80 males and 19 females, 10.4 years in mean age) were enrolled at 17 medical institutions in Japan-74, 60, 22, 9, 6, and 1 of whom had autism spectrum disorder, attention-deficit/hyperactivity disorder, intellectual disabilities, motor disorders, specific learning disorder, and communication disorders, respectively, at baseline. Fifteen children received the maximal dose of 4 mg among the prespecified dose levels. SOL recorded with the electronic sleep diary shortened significantly (mean ± standard deviation [SD], - 36.7 ± 46.1 min; 95% confidence interval [CI], - 45.9 to - 27.5; P < 0.0001) in the medication phase I from baseline, and the SOL-shortening effect of melatonin persisted in the medication phase II and the follow-up phase. Temper upon wakening and sleepiness after awakening improved significantly (P < 0.0001 each) in the medication phase I from baseline and persisted in the follow-up phase. The following subscales of the ABC-J improved significantly: stereotypic behavior (P = 0.0322) in the medication phase I; and irritability, hyperactivity, and inappropriate speech (P < 0.0001) in the medication phase II. Treatment-emergent adverse events did not occur subsequent to week 16 after medication onset, and NDDs did not deteriorate in the follow-up phase.
Conclusions:
Long-term melatonin treatment in combination with adequate sleep hygiene interventions may afford clinical benefits to children with NDDs and potentially elevates their well-being.
Trial Registration:
ClinicalTrils.gov , NCT02757066 . Registered April 27, 2016.
More Related Videos
Related Concept Videos
01:19Management of Insomnia
01:17Sedatives and Hypnotics Drugs: Miscellaneous Agents
Melatonin congeners like ramelteon (Rozerem) and tasimelteon (Hetlioz) selectively bind to melatonin receptors (MT1 and MT2) and thus mimic the actions of melatonin, a hormone that regulates sleep-wake cycles. Tasimelteon is primarily used for non-24-hour sleep-wake disorder, common in blind patients. They are also used to treat conditions like insomnia...
01:15REM Sleep Behavior Disorder
RBD is significantly associated with...
01:07Narcolepsy
01:27Insomnia
Multiple factors contribute...
01:18Nightmares and Night Terrors
Nightmares...