Universidade Regional do Noroeste do Estado do Rio Grande do Sul, Departamento de Ciências da Vida, Ijuí RS, Brazil.
Queensland University of Technology, Centre in Regenerative Medicine, Institute of Health and Biomedical Innovation, Kelvin Grove, Australia.
Arq Neuropsiquiatr. 2021 Aug;79(8):732-742. doi: 10.1590/0004-282X-ANP-2020-0379.
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.
To evaluate the effectiveness of melatonin in sleep disorders, its dosage, potential adverse effects, as well as labeling laws and regulations in Brazil.
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.
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.
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.
失眠是一种以入睡困难或维持睡眠困难为特征的睡眠障碍，影响不同年龄组的人群。目前，褪黑素被用作儿童、成人和老年人失眠的治疗方法。
评估褪黑素治疗睡眠障碍的有效性、剂量、潜在的不良反应，以及巴西的标签法规。
本综述性研究使用了 Cochrane 图书馆、Medline（Pubmed）和 Science Direct 数据库。共选择了 2015 年至 2020 年期间发表的 25 篇文章和 3 篇可在巴西内分泌学会和国家卫生监督局网站上获得的文件进行全文评估。
大多数选定的文章都发现褪黑素的使用可以降低睡眠潜伏期。有效褪黑素剂量因年龄组而异，儿童为 0.5 至 3 毫克，青少年为 3 至 5 毫克，成人 1 至 5 毫克，老年人 1 至 6 毫克。服用常用剂量时，副作用较轻。在巴西，没有发现注册药物，也没有关于褪黑素使用和销售的现行法规。
褪黑素的使用是一种治疗睡眠障碍的替代疗法。根据发现的证据，它没有表现出毒性或严重的副作用，即使在高剂量使用时也没有依赖性，这表明它是一种安全的药物，可以治疗不同年龄段的睡眠障碍患者。
