Potential safety issues in the use of the hormone melatonin in paediatrics

J Paediatr Child Health. 2015 Jun;51(6):584-9. doi: 10.1111/jpc.12840. Epub 2015 Feb 3.


Melatonin is a hormone produced by the pineal gland during the night in response to light/dark information received by the retina and its integration by the suprachiasmatic nucleus. When administered to selected populations of adults, in particular those displaying delayed sleep phase disorder, melatonin may advance the time of sleep onset. It is, however, being increasingly prescribed for children with sleep disorders despite the fact that (i) it is not registered for use in children anywhere in the world; (ii) it has not undergone the formal safety testing expected for a new drug, especially long-term safety in children; (iii) it is known to have profound effects on the reproductive systems of rodents, sheep and primates, as well as effects on the cardiovascular, immune and metabolic systems; and (iv) there is the potential for important interactions with drugs sometimes prescribed for children. In this review, I discuss properties of melatonin outside its ability to alter sleep timing that have been widely ignored but which raise questions about the safety of its use in infants and adolescents.

Keywords: behavioural; developmental; endocrinology; pharmacology; sleep.

Publication types

  • Review

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Epilepsy / drug therapy*
  • Humans
  • Infant
  • Melatonin / adverse effects
  • Melatonin / therapeutic use*
  • Patient Safety
  • Sleep / drug effects*
  • Sleep Wake Disorders / drug therapy*


  • Melatonin