Skrzelowski Michelle, Brookhaus Amanda, Shea Leticia A, Berlau Daniel J
J Pediatr Pharmacol Ther. 2021;26(1):4-20. doi: 10.5863/1551-6776-26.1.4. Epub 2021 Jan 4.
Melatonin manufacturers in the United States have begun producing melatonin products specifically targeted for use in the pediatric population. This paper aims to critically evaluate the evidence available regarding the use of melatonin in children based on where the clinical trials are performed and the regulations regarding the production of melatonin in that country. Melatonin is regulated differently around the world with the least amount of regulation placed on OTC supplements in the United States. The majority of studies evaluating melatonin use in the pediatric population are conducted with children who have comorbidities, such as autism spectrum disorder or attention-deficit/hyperactivity disorder. Evidence supporting the use of US formulations of melatonin in the otherwise healthy pediatric population is non-existent. Based on the lack of safety regulations in place in the United States and the lack of evidence regarding US melatonin products, they should be used sparingly in the otherwise healthy pediatric population, if they are used at all.
美国的褪黑素制造商已开始生产专门针对儿童群体使用的褪黑素产品。本文旨在根据临床试验的开展地点以及该国关于褪黑素生产的法规，严格评估有关儿童使用褪黑素的现有证据。世界各地对褪黑素的监管方式不同，美国对非处方补充剂的监管最少。大多数评估儿童使用褪黑素的研究是在患有共病的儿童中进行的，如自闭症谱系障碍或注意力缺陷多动障碍。目前尚无证据支持在健康的儿童群体中使用美国生产的褪黑素制剂。鉴于美国缺乏相关安全法规，且缺乏关于美国褪黑素产品的证据，即便要使用，也应在健康的儿童群体中谨慎使用。
