2023-11-13 13:28:04
Melatonin is not a nutritional supplement, but a drug, so specialists are calling for regulation that prevents abusive or erratic use by the population. The Spanish Sleep Society estimates the prevalence of chronic insomnia in the adult population at 14%.
The latest study by the Spanish Sleep Society (SES) puts the prevalence of chronic insomnia in the adult population of our country at 14% (estimated by the INE at around 38 million in 2022), which means that it has doubled since the year 2000 and confirms the importance of this disease. Children are also not immune to problems, mainly difficulty initiating and maintaining sleep (the most common), respiratory disorders, parasomnias, circadian rhythm disorders (adolescence) and restless legs. Globally, they affect 30% in pediatric age (about two million children under 16 years of age).
With this background, interest in using melatonin in the treatment of these conditions has also continued to increase. There are several factors that motivate this trend. It is a hormone secreted by the pineal gland with a circadian rhythm, which helps regulate the oscillation between sleep and wakefulness. Added to this chronoregulatory effect are immunological, antioxidant and oncostatic properties. In addition, it is easily synthesized and administered orally.
Its natural secretion is related to changes in light and darkness, along with other external synchronizers, such as diet, social habits and exercise. Its production reduces with age in a relationship inversely proportional to the frequency of poor quality sleep. This fact has reinforced the idea that its deficit is, at least in part, responsible for this type of disorder.
However, the effectiveness of an exogenous administration depends on whether the indication is well made and whether it is taken when appropriate. “You have to give it to whoever it touches, how it touches and with medical control because it is a drug,” summarizes Óscar Sans, coordinator of the Pediatric Group of the SES. “The success of melatonin has to do with how it is given, but above all when,” emphasizes Ainhoa Álvarez, neurophysiologist and coordinator of the Insomnia Group of the SES, which is why she considers the doctor’s intervention essential.
The latest study published by the SES Insomnia Group concludes that, as the main regulator of the rhythm of wakefulness and sleep, melatonin is a substance of “great interest” to address the problems of insomnia and sleep phase disorders: “Accentuate The physiological signal that makes us sleep seems to be the most natural approach to confront these alterations, especially when they occur at ages in which melatonin synthesis is decreased. The data we have, mainly with prolonged-release melatonin, indicate that it is effective, both in primary insomnia and insomnia associated with other neurological diseases, especially in people over 55 years of age.
Necessary regulation and medical control
The SES maintains that it is undeniable that melatonin is a drug and that as such it must be handled with the required quality controls. Its regulation is necessary, as well as medical control and prescription dispensing in adults and children.
“These products do not have clinical trials, nor pharmacokinetic or pharmacodynamic studies,” emphasizes Ainhoa Álvarez. In a letter sent to Public Health, the Pediatric Group of the SES already warned that these preparations for children have production processes “that produce great variability in both their composition and bioavailability.” And it concluded that melatonins available as a dietary supplement “are less safe and less effective for the treatment of insomnia.”
“The problem we are having with children is that they already come to us with melatonin on,” laments Óscar Sans, who warns that poor administration can cause a major sleep disorder: “It will not be a catastrophic effect, but in the medium term It will not work and you will stop taking it.”
The head of the Pediatric Group believes that the prescription is a necessary step so that the doctor has control and does not make indiscriminate use, in addition to ensuring that the drug is financed by the health system because the expense in serious cases can be very high.
In fact, this group of experts has already made a formal request to the administration for funding Slenyto in patients with neurological disorders and Ciercadin for its off-label use in children with the same indications as Slenyto.
In Spain, Circadin and Slenyto are marketed as prolonged-release drugs. “Studies with Circadin show that it improves sleep in people over 55 years of age. They are not as powerful drugs as hypnotics, but they help you sleep,” says Ainhoa Álvarez. Slenyto is used in pediatrics, where Circadin has off-label use. Óscar Sans supports the effectiveness of melatonin in children when there is difficulty initiating sleep, in adolescents with phase delay problems and neurodevelopmental disorders.
It is important to clarify the instructions. According to the coordinator of the Insomnia Group, in adults there are basically two and the pattern is different. One is phase delay disorders. These patients should take melatonin twelve hours before getting up because it is used as a circadian rhythm regulator. In insomnia, and when there are no additional disorders such as anxiety, depression or chronic pain, half an hour before going to bed and it is essential to reinforce sleep hygiene. The usual dose is between 1 and 3 mg per day.
SES specialists warn that there are many products marketed as dietary supplements and therefore subject to much less strict regulation and control mechanisms, which can be purchased in herbalists and supermarkets. Even preparations adapted for children due to their presentation in drops, sprays or gummies.
In the pediatric age
It should not be used with children before they reach the first year of life, because circadian rhythms are not mature. Nor is any type of treatment recommended without first working with correct routines. As Óscar Sans explains, they are twenty-four-hour measurements, which have to do with sleeping and eating times: “The intestine is our second brain and we do not take it into account. If I eat late, I will sleep later because the brain understands that it is not time.”
The pediatrician must keep a sleep diary to know how the child sleeps and when sleep begins to know what time to administer melatonin, which will be an hour before. The indication is that there are difficulties in initiating sleep and the dose is usually 0.5 to 3 mg. “If there are nocturnal awakenings (three or more during the night), we must check that they are not due to other causes, such as a respiratory disorder or that the ferritin is below 50 mg/liter.” In adolescents, a phase delay may occur, which is linked to this stage of life, although screen abuse may be involved. The time to take melatonin is between four and six hours before the time the patient usually falls asleep.
In children with neurodevelopmental disorders, it is also useful, especially in the autism spectrum: “Studies show that they improve the onset and maintenance of sleep.” Here the dose can be increased up to 6 mg.
Drugs with melatonin are well tolerated, they do not cause addiction nor do their withdrawal cause a rebound effect. Regarding this exogenous administration, Óscar Sans asserts that “it is better to sleep with melatonin at minimum effective doses than not to sleep at all.”
Let’s not forget cognitive behavioral therapy
Cognitive behavioral therapy is the first line of treatment for chronic insomnia, a diagnosis that occurs when you have poor sleep for more than three months for three or more days a week. In the last congress of the SES, the data was provided that it has an effectiveness of 53%. “It is the first thing of all, even before using melatonin. Studies have shown that using drugs first and then therapy is not as effective as the other way around,” recalls Ainhoa Álvarez.
What’s more, the coordinator of the SES Insomnia Group recommends maintaining the therapy together with the administration of melatonin: “It helps the drug work better because, on the one hand, it tries to control thinking so that sleep comes and, on the other hand, , eliminates predictions, which are not a reality, such as today I am not going to sleep anymore or this is going to kill me.”
This expert urges primary care doctors to take early action: “It is an all-day disease and we must act before the problem gets bigger, do it from primary care, and ensure that the sleep units reach the more serious patients.” However, she recognizes the shortcomings of the first level of care and points out that, to do it effectively, the necessary tools must be provided. And one of them is precisely that specialists from hospital units go to health centers to teach cognitive behavioral therapy. Maria R. Lagoa
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