Melatonin for sleep disorders in children

Abstract

A 6½-year-old boy weighing 28 kg is taking melatonin 10.5 mg at night for insomnia associated with autistic spectrum disorder. There is concern that regular administration of this dose may be harmful as the British National Formulary (BNF) for children recommends a maximum of 10 mg daily. The drug is unlicensed in children and a wide range of doses has been used in small-scale clinical studies. One systematic review and meta-analysis of small-scale studies of melatonin for sleep disorders in autistic spectrum disorder found that in patients aged 2-18 years the dosage of melatonin ranged from 0.75 mg to 15 mg with occasional use of 25 mg. There is very limited evidence for using doses in excess of 10 mg daily. However, melatonin has not been shown to be associated with severe adverse effects over a wide range of doses, therefore a dose of 10.5 mg daily for a 6½-year-old child is unlikely to cause significant harm.

Melatonin: From Pharmacokinetics to Clinical Use in Autism Spectrum Disorder

“…There is no real consensus on the optimal daily dose of melatonin for sleep disturbances in children with ASD. French TRU recommends titration until a 6 mg daily dose [ 105 ] of melatonin and, although unlicensed in the UK for use in children, the British National Formulary for Children recommends a 10 mg maximum daily dose in children “aged 1 month to 17 years” [ 106 ]. This lack of official recommendation highlights the potential clinical relevance of summarizing safety and dosing data from clinical trials and post-marketing authorization reports.…”