12 – 17 These compounds include medications that have been both banned and approved by the FDA, some of which have modified chemical structures with similar pharmacological activity. Many dietary supplements marketed in the United States have been discovered by the FDA to be tainted with compounds that do not appear on the product label. In the United States, melatonin is regulated as a dietary supplement. 11 This outbreak resulted in 1500 cases and 30 deaths. Eosinophilia-myalgia syndrome, a disease that occurred in an epidemic outbreak, was linked to L-tryptophan containing dietary supplements. 9, 10 Detection of tryptophan in these supplements is concerning. 9 Studies evaluating purity of melatonin products determined contaminants such as tryptophan-related compounds as well as significant quantities of serotonin. Researchers outline the concern of serotonin contamination as serotonin overdoses can occur with relatively low levels of serotonin. It is important to recognize that although melatonin is an endogenous hormone in the body, the melatonin available for purchase is a synthetically made compound. 7 Information about the role of melatonin on pubertal development is limited, and further research is needed to address the use of melatonin as a sleep aid in younger populations, and how it may affect pubertal development. 4 – 7 Young adults typically secrete 5 to 25 mg of melatonin every evening. 4 Melatonin is also involved in growth hormone secretion and sexual maturation. 1 – 3 The retina of the eye senses darkness and sends a trigger to the hypothalamus, stimulating melatonin secretion from the pineal gland. It is involved with the human body's circadian rhythm, otherwise known as the sleep-wake cycle. Melatonin is a hormone produced by the pineal gland. 1, 2 Many factors must be considered when evaluating this evidence, including where the study was completed, whether melatonin is considered a prescription or dietary supplement in the country performing the research, type of sleep disorder, length of therapy, age of the study participants, and comorbid disease considerations.
Melatonin is commonly used as a remedy for various sleep disorders however, there is conflicting evidence about the efficacy and safety of melatonin for these indications. 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. Evidence supporting the use of US formulations of melatonin in the otherwise healthy pediatric population is non-existent. 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.
Melatonin is regulated differently around the world with the least amount of regulation placed on OTC supplements in the United States. 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 manufacturers in the United States have begun producing melatonin products specifically targeted for use in the pediatric population.
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