Melatonin for sleep disturbance in children with neurodevelopmental disorders: prospective observational naturalistic study

Abstract

Background: Although melatonin is increasingly used for sleep disturbances in children with neurodevelopmental disorders, evidence on effective dose and impact on specific types of sleep disturbance is limited. Method: We assessed 45 children (35 males, mean age: 6.3 ± 1.7 years) with neurodevelopmental disorders (n = 29: intellectual disability; n = 9: autism spectrum disorder; n = 7: attention-deficit/hyperactivity disorder) and sleep disturbances, treated with melatonin (mean duration: 326 days) with doses increased according to response. Results: Thirty-eight percent of children responded to low (2.5–3 mg), 31% to medium (5–6 mg) and 9% to high doses (9–10 mg) of melatonin, with a significant increase in total hours of sleep/night, decreased sleep onset delay and decreased number of awakenings/night (all: p = 0.001), as measured with sleep diaries. No serious adverse events were reported. Conclusions: Melatonin is generally effective and safe in children with neurodevelopmental conditions. Increasing above 6 mg/night adds further benefit only in a small percentage of children.

Keywords:

• attention-deficit/hyperactivity disorder
• autism spectrum disorder
• children
• intellectual disability
• melatonin
• sleep

Acknowledgements

The authors are very grateful to Prof. Rudolf and Dr. Wyatt for advice on the study design and to Prof. Walter for his guidance on the statistical analyses.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Melatonin is safe and effective in the majority of children with neurodevelopmental disorders.

• Melatonin improves total hours of sleep/night, sleep onset delay and number of awakenings/night.

• If a child with a neurodevelopmental disorder does not respond to low or moderate dose of melatonin, increasing to higher does is unlikely to add further benefit.

• However, although higher doses might indeed be beneficial for a small percentage of children.

• A key area of research for the future is the investigation of the added value of combining behavioral therapies to melatonin to improve sleep patterns in children with neurodevelopmental disorders.