Composition of food supplements containing melatonin available in Portugal

Abstract Melatonin straddles the boundary between food supplements and medicine. In Portugal, its classification is contingent upon a critical dosage threshold of 2 mg. This study aimed to detail the composition of melatonin-containing food supplements, available in Portugal based on their labels, a...

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Main Authors: Beatriz Vieira Araújo, Fátima Rato, João Paulo Capela
Format: Article
Language:English
Published: Universidade de São Paulo 2025-01-01
Series:Brazilian Journal of Pharmaceutical Sciences
Subjects:
Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502025000100327&lng=en&tlng=en
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author Beatriz Vieira Araújo
Fátima Rato
João Paulo Capela
author_facet Beatriz Vieira Araújo
Fátima Rato
João Paulo Capela
author_sort Beatriz Vieira Araújo
collection DOAJ
description Abstract Melatonin straddles the boundary between food supplements and medicine. In Portugal, its classification is contingent upon a critical dosage threshold of 2 mg. This study aimed to detail the composition of melatonin-containing food supplements, available in Portugal based on their labels, and report the number of potential intoxications. Data was collected from 44 food supplements, and the difference in active ingredients was revealed towards the 16 approved medicines. Data on melatonin intoxication cases from 2018 to 2022 were obtained from the Portuguese Poisons Information Center (CIAV). Melatonin supplements, available in tablets, capsules, gummies, powders, or sprays, exhibited a recommended daily dose ranging from 1 to 1.95 mg. Only 20% contained melatonin alone, while the majority included plant extracts and vitamins. The absence of clinical studies supporting the efficacy of melatonin combined with plant extracts in these formulations raises concerns about their evidence-based effectiveness. Medicines contain 2 to 3 mg of melatonin per tablet, either immediate or modified release. Melatonin intoxication occurs mainly in children, with a higher prevalence between the first year of life and the age of four. Food supplements containing melatonin and plant extracts should be more carefully studied, including the potential adverse effects.
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series Brazilian Journal of Pharmaceutical Sciences
spelling doaj-art-94f8e42118bb4321816de085a235ea0e2025-01-21T07:42:33ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences2175-97902025-01-016110.1590/s2175-97902025e24287Composition of food supplements containing melatonin available in PortugalBeatriz Vieira AraújoFátima RatoJoão Paulo Capelahttps://orcid.org/0000-0003-2607-1264Abstract Melatonin straddles the boundary between food supplements and medicine. In Portugal, its classification is contingent upon a critical dosage threshold of 2 mg. This study aimed to detail the composition of melatonin-containing food supplements, available in Portugal based on their labels, and report the number of potential intoxications. Data was collected from 44 food supplements, and the difference in active ingredients was revealed towards the 16 approved medicines. Data on melatonin intoxication cases from 2018 to 2022 were obtained from the Portuguese Poisons Information Center (CIAV). Melatonin supplements, available in tablets, capsules, gummies, powders, or sprays, exhibited a recommended daily dose ranging from 1 to 1.95 mg. Only 20% contained melatonin alone, while the majority included plant extracts and vitamins. The absence of clinical studies supporting the efficacy of melatonin combined with plant extracts in these formulations raises concerns about their evidence-based effectiveness. Medicines contain 2 to 3 mg of melatonin per tablet, either immediate or modified release. Melatonin intoxication occurs mainly in children, with a higher prevalence between the first year of life and the age of four. Food supplements containing melatonin and plant extracts should be more carefully studied, including the potential adverse effects.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502025000100327&lng=en&tlng=enMelatoninN-acetyl-5-methoxytryptamineDietary supplementMedicineIntoxication
spellingShingle Beatriz Vieira Araújo
Fátima Rato
João Paulo Capela
Composition of food supplements containing melatonin available in Portugal
Brazilian Journal of Pharmaceutical Sciences
Melatonin
N-acetyl-5-methoxytryptamine
Dietary supplement
Medicine
Intoxication
title Composition of food supplements containing melatonin available in Portugal
title_full Composition of food supplements containing melatonin available in Portugal
title_fullStr Composition of food supplements containing melatonin available in Portugal
title_full_unstemmed Composition of food supplements containing melatonin available in Portugal
title_short Composition of food supplements containing melatonin available in Portugal
title_sort composition of food supplements containing melatonin available in portugal
topic Melatonin
N-acetyl-5-methoxytryptamine
Dietary supplement
Medicine
Intoxication
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502025000100327&lng=en&tlng=en
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AT joaopaulocapela compositionoffoodsupplementscontainingmelatoninavailableinportugal