Abstract

Introduction: sleep disorders in paediatrics are a growing problem. Melatonin is the drug of choice and it is common to receive advertising for multiple products containing melatonin in primary care. In this paper, a comparative analysis of these products is carried out, examining the most recent scientific evidence, in order to determine whether their use is justified or not. Methods: a descriptive study was conducted on melatonin-containing products sold in pharmacies in Spain and aimed at the paediatric population. Subsequently, a systematic review of documents on the use of melatonin in children and on each extra component present in the products collected was carried out. Results: fifty-three products were analysed. The most common form of administration was drops or millilitres. The usual recommended dose of melatonin was 1 mg per day. The most frequently reported added component was vitamin B6, and lemon balm and passionflower were the most frequently used herbs. None of the products were specifically listed in the Spanish Agency for Medicines and Health Products, and no bibliographical references were found in the advertising of any of the products. Conclusions: although the efficacy of melatonin in sleep disorders is well known, there is currently no consensus on its effective dose in children. The substances most frequently associated with melatonin have little literature to support their results in sleep, and there are no standardised doses for them either, or doses lower than these are used due to a lack of studies in the paediatric population.

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