The use of MElatonin in children with Neurodevelopmental Disorders and impaired Sleep: a randomised, double-blind, placebo-controlled, parallel study (MENDS).

Abstract

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Melatonin for sleep problems in children with neurodevelopmental disorders

“…A prolonged-release formulation of melatonin is licensed for short-term treatment for primary insomnia in people aged 55 years or over 19. Unlicensed preparations of immediate-release melatonin are often prescribed for children who have difficulty sleeping 16. Although melatonin is thought to have few unwanted effects, there are concerns about its relationship to epileptic seizures, and delays in sexual maturation (reported in animal studies; effects on the onset of puberty in children are uncertain) 14,18…”

“…Melatonin reduced SOL measured by sleep diaries (−38 minutes, 95% CI −55 to −20, p<0.001) and actigraphy (−45 minutes, 95% CI −69 to −22, p<0.001). Seven serious adverse events were reported, of which two (one in the placebo group and one in the melatonin group) were considered related to the study drug in a blinded assessment 16,28…”

Melatonin for sleep disorders in children

“…In a study of 21 children with ASD who also had epilepsy, there was no increase in seizure activity 6. Seizure exacerbation was not seen in the children with an established diagnosis of epilepsy in the MENDS trial (11% of the trial population) 7. The most common dose used in studies of melatonin for sleep disorders in children appears to be 3 mg, with a range of 1–10 mg. National Institute for Health and Care Excellence advice on melatonin in children with attention deficit hyperactivity disorder and sleep onset insomnia is based on three randomised controlled trials.…”

“…The dose was escalated through 2 mg, 6 mg to 12 mg during the first 4 weeks at the end of which the child was maintained on that dose. One hundred and forty-six children aged 3–15 years were randomised 7. At week 12, of the remaining 65 patients in the melatonin group, 38.5% were taking 12 mg.…”

Use of Melatonin for Sleep Disorders in Children with Cerebral Palsy

“…Few studies reported results on the use of melatonin in children with neurodevelopmental disabilities (ND) including CP patients, even if not exclusively [6][7][8][9][10][11][12][13]. In these studies melatonin has been administered 30-60 minutes before the child's usual bedtime with a dose ranging from 0.5 to 12 mg for a period >4 weeks, showing an effect in both reducing the time to sleep onset or sleep latency and increasing the total duration of continuous sleep throughout the night.…”