HealthDay News — Considerable safety concerns surround use of melatonin for children with sleep disorders, according to a review article published in the Journal of Paediatrics and Child Health.

David J. Kennaway, PhD, from the University of Adelaide in Australia, examined safety issues associated with prescription of melatonin for children with sleep disorders.

Kennaway notes that because melatonin is considered a dietary supplement and not a drug, it has not been evaluated for safety in any population group. No appropriate studies have demonstrated the safety of melatonin in children or adults.

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Apart from use in patients aged older than 55 years with primary sleep disorder, all other uses of melatonin are off-label.

Research in animal models, including rodents, sheep, and primates, has shown that melatonin can have significant effects on the reproductive organs, and long-term endocrine effects have not been assessed in children and adolescents.

Furthermore, there is potential for interactions with drugs prescribed to children for sleep disorders.

“Prescription of melatonin to any child whether severely physically or neurologically disabled or developing normally should be considered only after the biochemical diagnosis of an underlying sleep timing abnormality and after full disclosure to the carers of information about the known actions of melatonin on reproductive and other systems in animal models and the disclosure that there is a lack of appropriate studies conducted in children,” Kennaway wrote.


  1. Kennaway DJ, et al. J Paediatr Child Health. 2015; doi: 10.1111/jpc.12840.