Translation of a-t 2026; 57: 47

Paediatricians demand ban on “sweets” containing melatonin

For a number of years, the pineal gland hormone melatonin (MELLOZZAN, SLENYTO and others) has been approved as a prescription-only medicinal product for the treatment of sleep disorders in children and adolescents with autism spectrum disorder, ADHD or rare neurogenetic diseases, in each case if sleep hygiene measures were insufficient.^1,2* In addition to this, however, the hormone is also broadly marketed for children as a food supplement – freely available without the need to test the efficacy and safety and without systematic recording of adverse effects (see a-t 2025; 56: 9-10). The Nutrition Committee of the German Society of Paediatrics and Adolescent Medicine (Deutsche Gesellschaft für Kinder- und Jugendmedizin, DGKJ) is now demanding a ban on food supplements containing melatonin in the form of "sweets that are suitable for children", like gummi bears.³ They are advertised as "little sleeping aids for children"⁴ or "gummies for sleeping...(with) a blackberry taste all kids will love"⁵ and "a convenient and fun way to give melatonin".⁵ According to the declarations on them, the products we examined, WICK ZzzQUIL GUTE NACHT KIDS and SLEEPY HEAD, contain 0.5 mg⁴ and 1 mg,⁵ respectively, of melatonin per gummi and are marketed as suitable for children from the age of 4⁴ or 3⁵ years old, respectively. The recommended daily dose of 0.5 mg to 1 mg shortly before going to sleep is in the lower range of the doses (0.5 mg to 10 mg per day) authorised for medicinal products for children.^1,2 Unsurprisingly, both providers advertise with the health claim approved by the European Commission "melatonin contributes to the reduction of time taken to fall asleep".^4,5 This may actually only be used for products that contain 1 mg melatonin per item and for which taking 1 mg at night is recommended,⁶ which does not apply to the WICK gummies. In a meta-analysis⁷ published in 2023, an average reduction in time to fall asleep of a modest 18 minutes was calculated for otherwise healthy children and adolescents receiving 3-5 mg melatonin (95% confidence interval 9.4-26.6 minutes). Adverse effects are not declared for the two products, meanwhile, as is often the case for food supplements. Among other things, tiredness in the mornings, somnolence, aggressiveness, irritability, nightmares and headaches are listed as uncommon to common negative effects in the summaries of product characteristics for medicinal products for children containing melatonin.^1,2 In the US, melatonin was the substance most commonly taken by children reported to the national emergency poison control call centre in 2020. Between 2012 and 2021, the annual number of reports of this type there increased by 530%, accompanied by an increase in hospitalisations. Unintentional consumption by children under the age of 6 increased in particular. Two deaths were documented in this survey.⁸ In the case of food supplements containing melatonin, the risk of overdose is not only due to them being confused with sweets, but is also a result of the fact that several investigations have determined quantities deviating significantly from the declared quantities, with the levels significantly exceeding or falling below the already broad tolerance range of +/- 50% (a-t 2026; 57: 14).^9,10 In addition to the ban on melatonin in the form of sweets, the DGKJ Nutrition Committee is also demanding strict regulation on the sale of the hormone. Its use in children should be restricted exclusively to cases under medical control and only where there is a clear medical indication for this. In the case of sleep disorders in children, parents and carers must be informed in detail about the risks of melatonin and the alternative, evidence-based, non-pharmacological strategies to help children fall asleep,³ -Ed.

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