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


METHODS
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.
Integrated Paediatrics, Child and Adolescent Mental Health Services, Cambridgeshire and Peterborough NHS Mental Health Foundation Trust, A Member of Cambridge University Health Partners, Winchester Place, Peterborough, PE3 6AP, UK.
Hani F
HF
Ayyash
Phillip
P
Preece
Richard
R
Morton
Samuele
S
Cortese
D000704:Analysis of Variance; D002492:Central Nervous System Depressants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008607:Intellectual Disability / Q000209:etiology; D008297:Male; D008550:Melatonin / Q000627:therapeutic use*; D065886:Neurodevelopmental Disorders / Q000150:complications*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology*; D016896:Treatment Outcome
D002492:Central Nervous System Depressants; D008550:Melatonin
attention-deficit/hyperactivity disorder; autism spectrum disorder; children; intellectual disability; melatonin; sleep