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A sleep aid that resembles candy is drawing increasing attention from pediatricians. German child health experts are calling for a ban on melatonin-containing gummy bears and similar products, arguing that their marketing may blur the line between medically supervised treatment and confectionery.

Melatonin is a hormone that regulates the human sleep-wake cycle.

The German Society for Pediatrics and Adolescent Medicine (DGKJ) urged a ban on melatonin-containing dietary supplements that are marketed as gummy bears and other candy-like products. While melatonin is approved in Germany for only limited pediatric and adolescent indications under medical supervision, many over-the-counter supplements are sold without rigorous approval or safety requirements as prescription medications.

Trivialization Risk

The DGKJ considers this a significant concern.

“When a hormonally active substance like melatonin is marketed as a gummy bear, it quickly gives the impression that it is a harmless candy. This significantly downplays the effects. At the same time, the attractive form of administration increases the risk that children will consume several pieces unsupervised, leading to overdoses,” said Thomas Lücke, MD, chair of the DGKJ Nutrition Commission.

Limited Data

The DGKJ reported that possible side effects in children include morning fatigue, headaches, unsteadiness, and nightmares. Reliable data on long-term safety, particularly on hormonal development, puberty, and potential cardiovascular effects, are currently largely lacking. International reports also indicated an increase in melatonin-related emergencies in children resulting from improper use.

The Federal Institute for Risk Assessment also strongly advises against the independent, unmonitored administration of melatonin-containing dietary supplements to children and adolescents.

Clear Guidance

Pediatricians and child health specialists emphasized that sleep problems in childhood can often be managed without medication. Recommended measures include consistent bedtimes, structured evening routines, a quiet sleep environment, and avoiding screen use before bedtime. Lücke noted that children should be encouraged to develop healthy sleep habits and learn to fall asleep independently. This approach is more sustainable and safer in the long term than administering a hormone.

The DGKJ advised parents to discuss any sleep problems with their pediatrician. According to the organization, melatonin should be used only when there are clear medical indications and under medical supervision. The association also called for stricter regulations and a ban on melatonin-containing dietary supplements marketed in child-friendly candy forms.

This story was translated from Univadis Germany, part of the Medscape Professional Network.