SLEEP : Food supplements with melatonin; ANSES alert on the risks

Melatonin-based dietary supplements can lead to general, neurological or gastroenterological adverse effects, according to ANSES, which analyzed 90 reports of adverse effects following the intake of these products, which are still poorly regulated.

Some populations at higher risk should avoid the consumption of food supplements containing melatonin, according to the Health Security Agency (ANSES). The latter has received 90 reports of adverse effects from 2009 to May 2017 following the taking of these types of products, and 19 of them were sufficiently documented to conclude that the product is attributable. It is on the basis of this analysis that ANSES has produced recommendations for the use of these food supplements, the melatonin dosage of which may be equivalent to that of certain medicinal products, in the absence of data deemed sufficient on the safety of such a daily dose.

General, neurological and gastroenterological adverse effects :

Melatonin is a hormone produced during the night that modulates mood, immune system, body temperature, intestinal motility and biological clock. Thus, taking melatonin promotes sleep and is mainly marketed to "reduce the effect of jet lag" or "reduce sleep time". A study quoted by the ANSES report establishes that "when melatonin is administered in the afternoon or in the evening, (...) the peak melatonin secretion occurs earlier, with a sedative effect causing an increase in the feeling of fatigue, an increase in the reaction time and a decrease in sleep latency ". Melatonin "also has a vasodilatory, vasoconstrictor and pro-inflammatory action," warns ANSES, physiological effects that may, "under certain conditions, or during interaction with other substances, lead to the appearance of side effects". These can be varied, since ANSES reports receiving reports for "general symptoms (headache, dizziness, drowsiness, nightmares, irritability), neurological (tremors, migraines) and gastroenterological disorders (nausea, vomiting, abdominal pain)" more consumption of food supplements containing melatonin. Users had consumed the Somniphyt 30 supplements from the Green Health Laboratory, Melatonyl (Arkopharma), Novanuit (Sanofi), Melatonin (Solgar), Valdispert Melatonin (Vemedia pharma), Govital Melasomil (Urgo), Somdor Granions + Melatonin and Melatonin Valerian Sleep ( Vitarmonyl). Following an in-depth analysis of each case and the scientific literature, ANSES made recommendations on the consumption of these products and the associated risks.

Populations at risk for food supplements containing melatonin :

DO NOT CONSUMER. ANSES recommends not to consume melatonin in the form of food supplements "for people suffering from inflammatory or autoimmune diseases, pregnant and lactating women, children, adolescents and persons who need to carry out an activity requiring sustained vigilance and may pose a safety problem in case of drowsiness ".

MEDICAL ADVICE RECOMMENDED. The Agency advises against the consumption of food supplements containing melatonin without medical advice "for people with epilepsy, asthma, mood, behavior or personality disorders or following medication".

With nearly 1.4 million tins sold each year in France, melatonin has been gaining popularity since its first marketing authorization in 2007 as a drug. Food supplements containing up to 2 mg of melatonin, doses comparable to those of the prescription drug, are now available over the counter. In the absence of sufficient data on the safety of daily consumption of such a dose, ANSES questions "the place of melatonin on the market as a dietary supplement at doses comparable to those of the drug ". The Agency therefore considers it necessary "that a harmonized regulatory framework be defined at European level on the basis of safety studies conducted for doses of less than 2 mg". It specifies that the authorized dose in food supplements varies widely from one country to another: 2mg also in Latvia, 1mg in Cyprus, Croatia, Spain, Greece, Italy and Poland, 0.28mg in Germany, and not allowed in Denmark, the Czech Republic, the United Kingdom, Slovenia and Switzerland.

Dietary supplements in general are products to consume with care :

In general, ANSES recalls that food supplements are not innocuous products, and that it should be pointed out that they have been taken and any undesirable effects related to their doctor. "There is no scientific basis for all that claim to prevent or cure these products," said pharmacologist Jean-Paul Giroud, of the Academy of Medicine, while a study of the National Union of Dietary Supplements (Synadiet) March 28, 2018 revealed that two-thirds of French people were convinced of the health benefits of food supplements ... That is the same proportion as those who admitted not being very knowledgeable about the subject. "Deficits and, a fortiori, nutrient deficiencies are very rare in the general population", confirms ANSES on its website, pointing out exceptions such as vitamin D and "particular groups of the population (pregnant women, people elderly in institutions, populations in situations of great precariousness, for example) ". But "for a large majority of the population, a balanced diet can provide the essential nutrients necessary to cover the needs," writes ANSES. Thus, the Agency recommends "to limit the intake of these food supplements to a specific use". According to the Agency, it is important when consuming dietary supplements:

• to favor simple formulations and to avoid the concomitant use of several food supplements, in order to limit the risks of interactions,
• to avoid prolonged, repeated or multiple taking during the year of food supplements without consulting the advice of a health professional,
• scrupulously respect the conditions of use laid down by the manufacturer responsible for the safety of the products he markets,
• to report to a health professional any adverse reaction occurring following the consumption of a dietary supplement.

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