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Published on: October 2, 2019
Melatonin for sleep problems in children with neurodevelopmental disorders: randomised double masked placebo
P Gringras1, C Gamble, A P Jones
1King's College London and Evelina Children's Hospital, St Thomas' Hospital, London SE1 7EH, UK. Paul.Gringras@gstt.nhs.uk
Insights
Melatonin treatment for children with neurodevelopmental disorders showed limited impact on total sleep time but significantly reduced sleep onset latency. While generally safe, improvements in child behavior and family functioning were not substantial.
Area of Science:
- Pediatric Neurology
- Sleep Medicine
- Pharmacology
Background:
- Severe sleep problems are common in children with neurodevelopmental disorders.
- Standardized behavioral interventions are often insufficient for these children.
- Melatonin is a potential therapeutic agent for sleep disturbances.
Purpose of the Study:
- To evaluate the efficacy and safety of melatonin for severe sleep issues in children with neurodevelopmental disorders.
- To compare immediate-release melatonin with placebo in a pediatric population.
- To assess the impact of melatonin on sleep patterns, behavior, and family functioning.
Main Methods:
- A 12-week, double-blind, randomized, placebo-controlled trial involving 146 children (ages 3-15) across 19 UK hospitals.
- Participants received either immediate-release melatonin or placebo, with dosages titrated based on response.
- Sleep was monitored using parent-completed sleep diaries and actigraphy, with secondary outcomes including behavior and family functioning.
Main Results:
- Melatonin increased total sleep time by approximately 22 minutes (diary) and 13 minutes (actigraphy) but was not statistically significant for actigraphy.
- Significant reductions in sleep onset latency were observed with melatonin, particularly in children with longer initial sleep latencies.
- Earlier waking times were noted with melatonin, and while some improvements in child behavior and family functioning favored melatonin, they were not statistically significant. Adverse events were mild and comparable between groups.
Conclusions:
- Immediate-release melatonin offers a tolerable option for children with neurodevelopmental disorders and severe sleep problems, primarily by reducing sleep onset latency.
- The overall increase in total sleep time was modest, and earlier waking times may offset some benefits.
- Further research comparing melatonin with slow-release formulations or analogues is warranted.
Objective:
To assess the effectiveness and safety of melatonin in treating severe sleep problems in children with neurodevelopmental disorders.
Design:
12 week double masked randomised placebo controlled phase III trial.
Setting:
19 hospitals across England and Wales.
Participants:
146 children aged 3 years to 15 years 8 months were randomised. They had a range of neurological and developmental disorders and a severe sleep problem that had not responded to a standardised sleep behaviour advice booklet provided to parents four to six weeks before randomisation. A sleep problem was defined as the child not falling asleep within one hour of lights out or having less than six hours' continuous sleep.
Interventions:
Immediate release melatonin or matching placebo capsules administered 45 minutes before the child's bedtime for a period of 12 weeks. All children started with a 0.5 mg capsule, which was increased through 2 mg, 6 mg, and 12 mg depending on their response to treatment.
Main Outcome Measures:
Total sleep time at night after 12 weeks adjusted for baseline recorded in sleep diaries completed by the parent. Secondary outcomes included sleep onset latency, assessments of child behaviour, family functioning, and adverse events. Sleep was measured with diaries and actigraphy.
Results:
Melatonin increased total sleep time by 22.4 minutes (95% confidence interval 0.5 to 44.3 minutes) measured by sleep diaries (n=110) and 13.3 (-15.5 to 42.2) measured by actigraphy (n=59). Melatonin reduced sleep onset latency measured by sleep diaries (-37.5 minutes, -55.3 to -19.7 minutes) and actigraphy (-45.3 minutes, -68.8 to -21.9 minutes) and was most effective for children with the longest sleep latency (P=0.009). Melatonin was associated with earlier waking times than placebo (29.9 minutes, 13.6 to 46.3 minutes). Child behaviour and family functioning outcomes showed some improvement and favoured use of melatonin. Adverse events were mild and similar between the two groups.
Conclusions:
Children gained little additional sleep on melatonin; though they fell asleep significantly faster, waking times became earlier. Child behaviour and family functioning outcomes did not significantly improve. Melatonin was tolerable over this three month period. Comparisons with slow release melatonin preparations or melatonin analogues are required.
Trial Registration:
ISRCT No 05534585.
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