Melatonin for Insomnia: The Dangers of Lack of Information on Labels

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Nearly half of melatonin-based food supplements present information to consumers that is not compliant, according to a survey conducted by the DGCCRF (1) the results of which were made public in November 2022.

Melatonin, known as “sleep hormones”, is secreted by the pineal gland of the brain from dusk to dawn, thus playing an important role in the synchronization of the biological clock.

A food supplement must contain less than 2 mg of melatonin per daily serving, products that contain doses of 2 mg and more are considered drugs.

Authorized health claims

Only two health claims relating to melatonin are authorized, recalls the DGCCRF:

  • Melatonin helps reduce the effects of jet lag“.

    This claim may only be used for a food containing at least 0.5 mg of melatonin per serving and if the consumer is informed that the beneficial effect is obtained by consuming at least 0.5 mg just before bedtime the first day of the trip and the few days following the day of arrival at destination.»

  • Melatonin helps reduce sleep time“.

    This claim can only be used for a food containing 1 mg of melatonin per serving and if the consumer is informed that the beneficial effect is obtained by consuming 1 mg before bedtime.»

Melatonin content

For 90% of the samples taken, the melatonin content was consistent with that mentioned on the label and the daily intake was less than 2 mg/day.

However, in almost half of the cases (45%), the labels do not inform the consumer in a consistent way about the dose necessary to obtain the advertised effect (from 1 mg for the reduction of the time of falling asleep and of 0.5 mg for the effect against jet lag).

Information on the terms of use

In addition, in 2018, ANSES (2) has published an opinion on food supplements containing melatonin which recommends:

  • to advise against this consumption for sensitive people, in particular those suffering from inflammatory or autoimmune diseases, pregnant or breastfeeding women, children and adolescents, people who have to carry out an activity requiring sustained vigilance and which may pose a safety problem in the event of drowsiness ;

  • to submit this consumption to a medical opinion for people with epilepsy, people with asthma, people suffering from mood, behavior or personality disorders and people on medication;

  • limit the intake of melatonin to occasional use;

  • to favor simple formulations that do not combine melatonin with other ingredients;

  • not to exceed the dose of 2 mg per day of melatonin.

The DGCCRF has observed a very heterogeneous integration of these recommendations. Some mentions are even contradictory with these, in particular by implying that the product can be used in children.

In nearly 70%, contrary to the recommendation, melatonin is combined with one or more plants/plant extracts (passionflower, lemon balm or valerian), which may represent risks of interactions, especially when other supplements or drugs are taken at the same time.

The results of this survey lead to a renewed call for consumer vigilance, concludes the DGCCRF.

In its 2018 report, ANSES indicated that 90 cases of adverse effects had been transmitted to it.

For more information on insomnia treatments, see the links below.

(1) Directorate General for Competition, Consumer Affairs and Fraud Prevention (DGCCRF, France).

(2) French National Agency for Food, Environmental and Occupational Health Safety (Anses).

Psychomedia with sources: DGCCRF, UFC-Que Choisir.
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