Autor/es reacciones

Javier Garjón Parra

Head of the Medicines Advisory and Information Service in the Pharmacy and Benefits Sub-Directorate

Melatonin is a hormone in the body that regulates sleep-wake cycles. It is the active ingredient in Slenyto®, a prescription medication indicated for insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder and/or neurogenetic disorders, and aged 6 to 17 years with attention deficit hyperactivity disorder, provided that sleep hygiene measures have been insufficient. Data are available for up to two years of treatment. The physician should periodically evaluate its effect and consider discontinuing it. As it is considered a safe substance, in the European Union, it can also be marketed as a food supplement and sold without a prescription.

Since melatonin is the leading cause of emergency room visits for overdose in young children (0 to 6 years) in the USA, the authors undertook a systematic review of its long-term effects (both positive and negative) in this age group. To this end, they searched for interventional and observational studies, as well as database registries.

One criticism that can be made of this article is a certain inconsistency. Its objectives are health outcomes, but its first conclusion concerns the increase in prescriptions. It doesn't define what it considers long-term and presents results from 2-14 weeks. The review finds hardly any information beyond that of clinical trials for the approved indications.

The recommendations are reasonable, but stem more from the scarcity of available information than from the review's findings: limiting the use of melatonin in young children to approved indications and always after trying non-pharmacological measures, the need for adequate supervision, and that it would be better to position melatonin as a medication rather than a supplement.

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