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CC BY-NC-ND 4.0 · Arq Neuropsiquiatr 2021; 79(08): 732-742
DOI: 10.1590/0004-282X-ANP-2020-0379
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Regulatory aspects and evidences of melatonin use for sleep disorders and insomnia: an integrative review

Aspectos regulatórios e evidências do uso de melatonina em distúrbio do sono e insônia: uma revisão integrativa
Ana Paula Rosinski Bueno 
1   Universidade Regional do Noroeste do Estado do Rio Grande do Sul, Departamento de Ciências da Vida, Ijuí RS, Brazil.
,
Flávia Medeiros Savi 
2   Queensland University of Technology, Centre in Regenerative Medicine, Institute of Health and Biomedical Innovation, Kelvin Grove, Australia.
,
Izabel Almeida Alves 
3   Universidade Federal da Bahia, Faculdade de Farmácia, Departamento do Medicamento, Salvador BA, Brazil.
,
Vanessa Adelina Casali Bandeira 
1   Universidade Regional do Noroeste do Estado do Rio Grande do Sul, Departamento de Ciências da Vida, Ijuí RS, Brazil.
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ABSTRACT

Background: Insomnia is a sleep disorder characterized by difficulty of falling asleep or maintaining sleep, which affects different age groups. Currently, melatonin is used as a therapeutic treatment in cases of insomnia in children, adults, and elderly people. Objective: To evaluate the effectiveness of melatonin in sleep disorders, its dosage, potential adverse effects, as well as labeling laws and regulations in Brazil. Methods: This integrative review was carried out using the Cochrane Library, Medline (Pubmed), and Science Direct databases. Twenty-five articles and three documents available on the Brazilian Society of Endocrinology and Metabology (SBEM) and National Health Surveillance Agency (ANVISA) websites published between 2015 and 2020 were selected to be evaluated in full. Results: It was found that in most of the selected articles the use of melatonin reduces sleep latency. The effective melatonin doses varied according to each age group, from 0.5 to 3 mg in children, 3 to 5 mg in adolescents, 1 to 5 mg in adults, and 1 to 6 mg in elderly people. Side effects are mild when taking usual doses. In Brazil, no registered drug and current regulation on the use and marketing of melatonin has been identified. Conclusion: The use of melatonin is an alternative therapy that can be used for sleeping disorders. According to the evidences found, it did not demonstrate toxicity or severe side effects, nor dependence even when administered at high doses, suggesting that it is a safe medication to treat patients of different ages suffering from sleeping disorders.

RESUMO

Antecedentes: Insônia é um distúrbio do sono caracterizado por dificuldade de iniciar e manter o sono, afetando diferentes faixas etárias. Atualmente, a melatonina é utilizada no tratamento de insônia em crianças, adultos e idosos. Objetivo: Avaliar a eficácia da melatonina nos distúrbios do sono, posologia e potenciais efeitos adversos, bem como a regulamentação vigente no Brasil. Métodos: Trata-se de uma revisão integrativa, os artigos foram identificados nas bases de dados Cochrane Library, Medline (Pubmed) e Science Direct, totalizando 25 artigos, e foram selecionados três materiais disponíveis no site da Sociedade Brasileira de Endocrinologia e Metabologia e Agência Nacional de Vigilância Sanitária, publicados entre 2015 e 2020. Resultados: Verificou-se na maioria dos artigos selecionados que a melatonina reduz a latência do sono. Quanto as dosagens de melatonina identificou-se variação em cada faixa etária, para crianças de 0,5 a 3mg; adolescentes de 3 a 5mg; adultos de 1 a 5mg e idosos 1 mg a 6 mg demostraram serem eficazes. Em doses habituais os efeitos colaterais são leves. No Brasil, não foi identificado medicamento registrado e regulamentação vigente sobre o uso e comercialização de melatonina. Conclusão: A utilização da melatonina é uma alternativa que pode ser utilizada em distúrbios do sono. De acordo com as evidências encontradas, não demonstrou toxicidade ou efeitos colaterais severos, nem dependência mesmo em doses elevadas, sendo, portanto, segura para tratamento de pacientes desde crianças a idosos que sofrem de distúrbios do sono.

Keywords:

Melatonin - Sleep Wake Disorders - Pineal Gland

Palavras-chave:

Melatonina - Transtornos do Sono-Vigília - Glândula pineal

Authors’ contribution:

APRB, IAA, VACB: contributed to the conception and design of the research project, data collection, data analysis and interpretation and writing of the article; FMS: contributed to the interpretation and editing of the article.




Publikationsverlauf

Eingereicht: 05. August 2020

Angenommen: 22. Dezember 2020

Artikel online veröffentlicht:
01. Juni 2023

© 2021. Academia Brasileira de Neurologia. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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