Concerns Raised Over Melatonin Spray Effectiveness

Sleep disturbances can significantly impact quality of life. However, caution is advised when considering melatonin-containing products for relief. A recent evaluation conducted by Öko-Test examined various melatonin sprays available in pharmacies, supermarkets, and health stores, assessing their efficacy and safety.

The study, led by experts from the Goethe University Frankfurt, involved a thorough analysis of the melatonin content in these products, alongside a review of their labeling compliance with German health regulations. The findings revealed that while melatonin is known to potentially shorten the time taken to fall asleep and extend overall sleep duration, the actual benefits are minimal, typically measured in single-digit minutes.

Moreover, side effects such as reduced alertness, unsteady gait, and daytime drowsiness can occur even after a single dosage. Long-term effects remain inadequately researched, leading to concerns from experts regarding the risk-benefit ratio of melatonin supplements. The German Federal Institute for Risk Assessment (BfR) has advised against unsupervised use, citing insufficient data to establish safety guidelines.

Current approved health claims state that a 1 mg dose can shorten sleep onset, while a dose of 0.5 mg may alleviate jet lag symptoms. However, many tested products exceeded the 1 mg threshold, with some showing discrepancies in melatonin content of up to 10%, far exceeding the 5% allowance set for medicinal products.

Only two of the examined sprays adequately warned against use in special risk groups, as highlighted by the BfR. Furthermore, out of the 19 products tested, 16 failed to meet safety and efficacy standards, including notable brands like Orthomol and Wick. The highest-rated products received only a 'satisfactory' rating, with the Vivinox Sleep Spray--containing both melatonin and lavender--ranked among them.

Some sprays also included plant extracts, which have not been substantiated by current clinical guidelines for sleep disorders. Additionally, controversial substances like Polysorbate 80 and artificial sweeteners, suspected of disrupting gut flora, were detected.

The study's outcomes emphasize the need for consumers to approach melatonin products with caution, particularly given the potential for adverse effects and the lack of robust evidence supporting their efficacy.