Sleep Aid Melatonin May Not Be Safe for Children

Increasing numbers of children with sleep disorders are being treated with the hormone melatonin, but the medication has not been approved for such use anywhere in the world and is understudied and risky, according to a paper in the Journal of Paediatrics and Child Health.

Author David Kennaway, Head of the Circadian Physiology Laboratory at the University of Adelaide, wrote that melatonin is “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 a press release Kennaway said, “The word ‘safe’ is used very freely and loosely with this drug, but there have been no rigorous, long-term safety studies of the use of melatonin to treat sleep disorders in children and adolescents.”

Warning on use of drug for children’s sleep (University of Adelaide press release, February 25, 2015)

Kennaway, David J. “Potential Safety Issues in the Use of the Hormone Melatonin in Paediatrics.” Journal of Paediatrics and Child Health, March 1, 2015, n/a – n/a. doi:10.1111/jpc.12840. (Abstract)