Specialist warns of excessive and unregulated consumption of melatonin

Melatonin, a substance known for its function of inducing sleep, is not registered in Brazil as a medicine. However, it can be found since 2017 in compounding pharmacies after a court decision contradicts Anvisa's resolution (National Health Surveillance Agency) and authorizes its importation. Its consumption has been considered excessive by experts, who point out the risks of side effects. "There are a lot of people talking and a lot of doctors prescribing," says José Cipolla Neto, professor of physiology at USP's Institute of Biomedical Sciences and researcher on the physiological effects and mechanisms of action of melatonin. It is a hormone naturally produced by the pineal gland, a small endocrine gland located near the central region of the brain. The most common role of melatonin is to signal to human organs that night has come and prepared the body to fall asleep. Therefore, it is commonly used by insomniacs to improve the quality of sleep.


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But the substance also plays a role in controlling food intake, in the synthesis and action of insulin in cells, among others. Due to its varied effect, the hormone fell in the taste of people in several countries. On the internet, it is offered to help with weight loss, fight diabetes, migraine control and even protect against the damage of Alzheimer's disease - although there is no scientific consensus on these supposed benefits. Although necessary for the organism, the substance has contraindications. According to Anvisa, "there are risks associated with the use of melatonin that cannot be ignored": the consumption of drugs containing the substance can cause swelling of the skin, mouth or tongue, loss of consciousness, depression, irritability, nervousness, anxiety, increased blood pressure and abnormal liver function, among other problems.




But the possible negative effects of consuming the hormone do not surprise interested parties. In the United States alone, where the product is sold as a food supplement and can be found in large supermarkets, at least 3 million people consume the substance frequently. According to estimates by the National Center for Complementary and Integrated Health of the American government, the use of melatonin more than doubled between 2007 and 2012, even with the lack of sufficient information on its long-term effects or consensus on its effectiveness as a sleep inducer. For Cipolla Neto, the scenario is one of overuse and, in some cases, abuse. "In the USA there are a lot of people taking extensively, which is a calamity, and we are going to the same situation here," he says. According to him, the release of a national drug will help Anvisa to have more control overconsumption. "The point is to create that it is not sweet candy and that needs to be managed properly. Otherwise, it can have serious consequences," he says.


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In Brazil, patients can buy formulations prepared by handling pharmacies, provided they have a prescription. According to Anfarmag, manipulated drugs can be prepared in capsules or in liquid pharmaceutical forms. There is no standard for doses, which are defined by doctors on a case-by-case basis. Since 2017, these establishments have purchased the active pharmaceutical ingredient from the company Active Pharmaceutica Ltda. - ME, which has been importing the substance into Brazil after winning an action against Anvisa and obtaining the release in a judicial manner. In a note, Anvisa said that the agency's resolution prohibits "the import and sale of pharmaceutical inputs intended for the manufacture of medicines that have not yet been evaluated for therapeutic efficacy" by the agency and that "it is not possible to sell melatonin as an active pharmaceutical ingredient in Brazil. "


I asked about the activity of Active Pharmaceutica Ltda. - ME, the agency did not answer whether it appealed or whether it will appeal the decision. According to the agency, drugs are only registered in the country after clinical trials prove their safety and effectiveness. At the moment, at least one Brazilian laboratory is conducting clinical trials with melatonin. In August 2016, Aché Laboratórios Farmacêuticos received the endorsement of the agency to do tests with the drug. Asked when it expects to submit results to Anvisa and if it expects to develop a commercial product from the studies, the company did not respond.


Indications and risks

Melatonin begins to be produced by the body at around 8 pm, and one of the first sensations it causes is sleep. Its effects, however, are also felt in metabolism, which changes to fast; in the cardiovascular system, which will lower blood pressure; and body temperature, among others, for the body to enter sleep. However, if taken in excess and outside the natural production schedule by the body, it can trigger chronic diseases, such as diabetes. "The amount that needs to be administered to the patient in the early evening cannot be large enough to remain (in the body) during the day. Otherwise, it can bring insulin resistance in the morning to the individual, which means starting the development of a diabetic condition ", explains Cipolla Neto. One of the common indications of melatonin is for the elderly. Aging naturally reduces the production of the substance and, in such cases, its replacement is recommended. "After a certain age, the pineal gland reduces the production of melatonin, sometimes up to 20% than when young," says the doctor. However, young people have been using the drug earlier and earlier, in part to combat growing insomnia, exacerbated by prolonged exposure to electronic equipment.  However, the presence of blue light on cell phones and computers signals to the body that it is still daytime and, with this, can delay the production of the hormone, causing difficulties to sleep.