{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,2]],"date-time":"2026-01-02T17:28:51Z","timestamp":1767374931440,"version":"3.41.2"},"reference-count":30,"publisher":"FapUNIFESP (SciELO)","license":[{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"am","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Funda\u00e7\u00e3o para a Ci\u00eancia e a Tecnologia","award":["UIDP\/04378\/2020"],"award-info":[{"award-number":["UIDP\/04378\/2020"]}]},{"name":"Funda\u00e7\u00e3o para a Ci\u00eancia e a Tecnologia","award":["UIDB\/04378\/2020"],"award-info":[{"award-number":["UIDB\/04378\/2020"]}]},{"name":"Funda\u00e7\u00e3o para a Ci\u00eancia e a Tecnologia","award":["LA\/P\/0140\/2020"],"award-info":[{"award-number":["LA\/P\/0140\/2020"]}]},{"name":"Associate Laboratory Institute for Health and Bioeconomy-i4HB","award":["UIDP\/04378\/2020"],"award-info":[{"award-number":["UIDP\/04378\/2020"]}]},{"name":"Associate Laboratory Institute for Health and Bioeconomy-i4HB","award":["UIDB\/04378\/2020"],"award-info":[{"award-number":["UIDB\/04378\/2020"]}]},{"name":"Associate Laboratory Institute for Health and Bioeconomy-i4HB","award":["LA\/P\/0140\/2020"],"award-info":[{"award-number":["LA\/P\/0140\/2020"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Braz. J. Pharm. Sci."],"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.1590\/s2175-97902025e24287","type":"journal-article","created":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T22:14:07Z","timestamp":1737411247000},"source":"Crossref","is-referenced-by-count":1,"title":["Composition of food supplements containing melatonin available in Portugal"],"prefix":"10.1590","volume":"61","author":[{"given":"Beatriz Vieira","family":"Ara\u00fajo","sequence":"first","affiliation":[{"name":"University Fernando Pessoa,  Portugal"}]},{"given":"F\u00e1tima","family":"Rato","sequence":"additional","affiliation":[{"name":"Centro de Informa\u00e7\u00e3o Antivenenos (CIAV),  Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2607-1264","authenticated-orcid":false,"given":"Jo\u00e3o Paulo","family":"Capela","sequence":"additional","affiliation":[{"name":"University Fernando Pessoa,  Portugal; University of Porto,  Portugal; University of Porto,  Portugal"}]}],"member":"530","published-online":{"date-parts":[[2025]]},"reference":[{"issue":"2","key":"ref1","doi-asserted-by":"crossref","first-page":"298","DOI":"10.1080\/10408398.2018.1524364","article-title":"Current regulatory guidelines and resources to support research of dietary supplements in the United States","volume":"60","author":"Bailey RL","year":"2020","journal-title":"Crit Rev Food Sci Nutr"},{"issue":"1","key":"ref2","doi-asserted-by":"crossref","DOI":"10.1111\/jsr.13119","article-title":"Covid-19 health crisis and lockdown associated with high level of sleep complaints and hypnotic uptake at the population level","volume":"30","author":"Beck F","year":"2021","journal-title":"J Sleep Res"},{"issue":"8","key":"ref3","doi-asserted-by":"crossref","first-page":"808","DOI":"10.1093\/jat\/bkac033","article-title":"Melatonin Supplementation in Undetermined Pediatric Deaths","volume":"46","author":"Bishop-Freeman SC","year":"2022","journal-title":"J Anal Toxicol"},{"issue":"9","key":"ref4","doi-asserted-by":"crossref","DOI":"10.3390\/nu10091135","article-title":"Dietary Melatonin Supplementation Could Be a Promising Preventing\/Therapeutic Approach for a Variety of Liver Diseases","volume":"10","author":"Bonomini F","year":"2018","journal-title":"Nutrients"},{"issue":"3","key":"ref5","doi-asserted-by":"crossref","first-page":"527","DOI":"10.1016\/j.ncl.2019.04.003","article-title":"Circadian Rhythm Sleep-Wake Phase Disorders","volume":"37","author":"Culnan E","year":"2019","journal-title":"Neurol Clin"},{"issue":"2","key":"ref6","doi-asserted-by":"crossref","first-page":"275","DOI":"10.5664\/jcsm.6462","article-title":"Melatonin Natural Health Products and Supplements: Presence of Serotonin and Significant Variability of Melatonin Content","volume":"13","author":"Erland LA","year":"2017","journal-title":"J Clin Sleep Med"},{"issue":"1","key":"ref7","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1186\/s12967-019-1835-1","article-title":"Pediatric sleep disturbances and treatment with melatonin","volume":"17","author":"Esposito S","year":"2019","journal-title":"J Transl Med"},{"issue":"11","key":"ref8","doi-asserted-by":"crossref","first-page":"1298","DOI":"10.2174\/0929867330666230224093849","article-title":"Sleep, Dietary Melatonin Supplementation, and COVID-19","volume":"31","author":"Gasmi A","year":"2024","journal-title":"Curr Med Chem"},{"issue":"1","key":"ref9","doi-asserted-by":"crossref","first-page":"518","DOI":"10.3390\/neurolint15010031","article-title":"Chronic Administration of Melatonin: Physiological and Clinical Considerations","volume":"15","author":"Givler D","year":"2023","journal-title":"Neurol Int"},{"issue":"3","key":"ref10","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1016\/j.neurol.2019.07.025","article-title":"Melatonin: A review of its potential functions and effects on neurological diseases","volume":"176","author":"Gunata M","year":"2020","journal-title":"Rev Neurol"},{"key":"ref11","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1016\/j.sleep.2023.12.018","article-title":"Factors contributing to U.S. parents\u2019 decisions to administer melatonin to children","volume":"114","author":"Hartstein LE","year":"2024","journal-title":"Sleep Med"},{"issue":"1","key":"ref12","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1177\/2042018813476084","article-title":"Therapeutic applications of melatonin","volume":"4","author":"Kostoglou-Athanassiou I","year":"2013","journal-title":"Ther Adv Endocrinol Metab"},{"issue":"22","key":"ref13","doi-asserted-by":"crossref","first-page":"725","DOI":"10.15585\/mmwr.mm7122a1","article-title":"Pediatric Melatonin Ingestions -United States, 2012-2021","volume":"71","author":"Lelak K","year":"2022","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"ref14","doi-asserted-by":"crossref","first-page":"104","DOI":"10.1016\/j.ctim.2019.05.024","article-title":"A combination of melatonin, vitamin B6 and medicinal plants in the treatment of mild-to-moderate insomnia: A prospective pilot study","volume":"45","author":"Lemoine P","year":"2019","journal-title":"Complement Ther Med"},{"key":"ref15","doi-asserted-by":"crossref","first-page":"888292","DOI":"10.3389\/fnagi.2022.888292","article-title":"Melatonin as an Anti-Aging Therapy for Age-Related Cardiovascular and Neurodegenerative Diseases","volume":"14","author":"Martin Gimenez VM","year":"2022","journal-title":"Front Aging Neurosci"},{"key":"ref16","article-title":"Significance of Melatonin in the Regulation of Circadian Rhythms and Disease Management","author":"Megha KB","year":"2024","journal-title":"Mol Neurobiol"},{"issue":"2","key":"ref17","doi-asserted-by":"crossref","DOI":"10.1111\/jpi.12782","article-title":"Safety of higher doses of melatonin in adults: A systematic review and meta-analysis","volume":"72","author":"Menczel Schrire Z","year":"2022","journal-title":"J Pineal Res"},{"issue":"4","key":"ref18","doi-asserted-by":"crossref","DOI":"10.3390\/nu9040367","article-title":"Dietary Sources and Bioactivities of Melatonin","volume":"9","author":"Meng X","year":"2017","journal-title":"Nutrients"},{"issue":"19","key":"ref19","doi-asserted-by":"crossref","DOI":"10.3390\/nu14193934","article-title":"Is Melatonin the \u201cNext Vitamin D\u201d?: A Review of Emerging Science, Clinical Uses, Safety, and Dietary Supplements","volume":"14","author":"Minich DM","year":"2022","journal-title":"Nutrients"},{"issue":"5","key":"ref20","doi-asserted-by":"crossref","first-page":"641","DOI":"10.1007\/s00431-018-3116-z","article-title":"Sleep disorders during childhood: a practical review","volume":"177","author":"Ophoff D","year":"2018","journal-title":"Eur J Pediatr"},{"issue":"3","key":"ref21","doi-asserted-by":"crossref","DOI":"10.1016\/j.heliyon.2020.e03648","article-title":"Influence of pH, temperature, and light on the stability of melatonin in aqueous solutions and fruit juices","volume":"6","author":"Pranil T","year":"2020","journal-title":"Heliyon"},{"issue":"4","key":"ref22","doi-asserted-by":"crossref","first-page":"425","DOI":"10.1517\/13543776.2014.1001739","article-title":"Therapeutic uses of melatonin and melatonin derivatives: a patent review (2012 -2014)","volume":"25","author":"Rivara S","year":"2015","journal-title":"Expert Opin Ther Pat"},{"issue":"5","key":"ref23","doi-asserted-by":"crossref","first-page":"1346","DOI":"10.1080\/13813455.2020.1770799","article-title":"Physiological and pharmacological perspectives of melatonin","volume":"128","author":"Samanta S","year":"2022","journal-title":"Arch Physiol Biochem"},{"issue":"1","key":"ref24","first-page":"4","article-title":"Melatonin Use in Pediatrics: Evaluating the Discrepancy in Evidence Based on Country and Regulations Regarding Production","volume":"26","author":"Skrzelowski M","year":"2021","journal-title":"J Pediatr Pharmacol Ther"},{"key":"ref25","doi-asserted-by":"crossref","first-page":"104647","DOI":"10.1016\/j.yrtph.2020.104647","article-title":"Regulatory landscape of dietary supplements and herbal medicines from a global perspective","volume":"114","author":"Thakkar S","year":"2020","journal-title":"Regul Toxicol Pharmacol"},{"issue":"3","key":"ref26","doi-asserted-by":"crossref","first-page":"434","DOI":"10.2174\/1570159X14666161228122115","article-title":"Melatonin: Pharmacology, Functions and Therapeutic Benefits","volume":"15","author":"Tordjman S","year":"2017","journal-title":"Curr Neuropharmacol"},{"key":"ref27","doi-asserted-by":"crossref","first-page":"49","DOI":"10.2147\/CIA.S361519","article-title":"Current Insights into the risks of using melatonin as a treatment for sleep disorders in older adults","volume":"18","author":"Tuft C","year":"2023","journal-title":"Clin Interv Aging"},{"issue":"10","key":"ref28","doi-asserted-by":"crossref","DOI":"10.3390\/nu13103480","article-title":"Circadian Rhythm Dysregulation and Restoration: The Role of Melatonin","volume":"13","author":"Vasey C","year":"2021","journal-title":"Nutrients"},{"key":"ref29","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1016\/B978-0-12-813814-4.00006-7","article-title":"The pineal as a gland and melatonin as a hormone","author":"Wurtman RJ","year":"2020","journal-title":"Hormonal Signaling in Biology and Medicine"},{"issue":"4","key":"ref30","first-page":"169","article-title":"Pharmacokinetics of Alternative Administration Routes of Melatonin: A Systematic Review","volume":"66","author":"Zetner D","year":"2016","journal-title":"Drug Res"}],"container-title":["Brazilian Journal of Pharmaceutical Sciences"],"original-title":[],"link":[{"URL":"http:\/\/www.scielo.br\/scielo.php?script=sci_pdf&pid=S1984-82502025000100327&tlng=en","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T22:14:20Z","timestamp":1737411260000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.scielo.br\/scielo.php?script=sci_arttext&pid=S1984-82502025000100327&tlng=en"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025]]},"references-count":30,"alternative-id":["S1984-82502025000100327"],"URL":"https:\/\/doi.org\/10.1590\/s2175-97902025e24287","relation":{},"ISSN":["2175-9790"],"issn-type":[{"type":"electronic","value":"2175-9790"}],"subject":[],"published":{"date-parts":[[2025]]},"article-number":"e24287"}}