Autor/es reacciones

Carlos Javier Egea Santaolalla

President of the Spanish Federation of Sleep Medicine Societies, coordinator of the Sleep Alliance Health Group, head of the Pulmonology Service and the Functional Sleep Unit of the Bioaraba Health Research Institute, coordinator of the SEPAR 2025-2026 year of sleep disorders and associate professor at the Faculty of Medicine of the University of the Basque Country

This is a systematic review of all published articles with scientific validity on the use of melatonin in children under 7 years of age, in any of its forms. It is a serious, well-structured article that answers the questions posed by the authors. We can draw several conclusions:

  1. It reveals that the use of melatonin in young children has been increasing steadily over the last decade, almost exponentially, multiplying its use fivefold since 2009 and especially after COVID-19. In fact, it is the substance most frequently used by parents without medical supervision, and even in cases of drug overdose, in children under 5 years of age. Most treatments have no side effects, although some deaths have been reported. In the USA, 90.2% of pediatric melatonin ingestions were accidental, suggesting that young children may be consuming their parents' melatonin. This review contributes to the evidence that there could be a clear public health problem regarding the increase in unsafe melatonin use in young children and its continued use beyond clinical recommendations.
  2. However, the studies considered to be of good quality in the review convey a clear message: that melatonin improves sleep onset in children with neurological conditions, such as autism spectrum disorder, but these effects are not clear in typically developing children. The clinical studies described indicate the safety of melatonin for children with neurological disorders similar to autism spectrum disorder (ASD), even with prolonged treatments of one to two years.
  3. Our only criticism is that the article includes observational studies from different countries with different national health systems and, therefore, different methods of obtaining melatonin. This means that the results obtained in healthy children in this review, where it appears to have no benefit, may not be representative of real-world situations.

These findings support the clinical practice of recommending melatonin for young children with ASD after, and always after, evaluating behavioral interventions, always under medical supervision. However, the report adds that there is no evidence to support this treatment practice in children without neurological disorders.

This necessitates improved support from pediatricians and parents for behavioral sleep practices, such as reducing screen time at night, establishing structured bedtime routines, etc.

Furthermore, given the increase in treatments and overdoses in countries without drug regulation, such as ours, we are encouraged to authorize melatonin as a prescription medication. This could improve usage estimates, medical supervision, and formulation accuracy. Secondly, it is necessary to develop treatment discontinuation strategies that allow for the safe reduction of melatonin use while promoting healthy sleep habits, in order to meet the recommendations for typically developing children.

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