Study links long-term melatonin use to increased risk of heart failure

Although the findings do not prove that melatonin itself is the cause of these risks, they raise new questions about the safety of a supplement often viewed as a "natural" and safe option for improving sleep.

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Why is melatonin so widely used?

Melatonin is a hormone produced by the pineal gland in the brain that helps regulate the sleep-wake cycle (circadian rhythm).

Its levels rise in the dark and fall during the day. Synthetic melatonin is available over the counter in many countries, where supplements are not strictly regulated, meaning their strength and purity vary between brands.

What did the study reveal?

The researchers divided the participants according to their melatonin use, placing those who had used it for a year or more in the “melatonin group” and those with no recorded use in the “non-melatonin group.” They used data from the global TriNetX network of electronic health records.

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The study included 130,828 adults with insomnia, with an average age of 55.7 years, of whom 65,414 had used melatonin for at least a year, with the two groups matched by age, sex, race, diseases, medications and other factors.

The researchers found that people who used melatonin for a long time (12 months or more) were 90% more likely to develop heart failure over the next five years, with heart failure occurring in 4.6% of the melatonin group compared to 2.7% in the comparison group.

When analyzing a group that met the requirement to fill melatonin prescriptions twice, at least 90 days apart, the association remained with an 82% higher risk.

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Hospitalization rates due to heart failure were about 3.5 times higher in the melatonin group (19.0% versus 6.6%), and deaths from any cause were also more common, reaching 7.8% versus 4.3%, meaning the risk was nearly twice as high.

Dr. Marie-Pierre Saint-Onge, a sleep researcher at Columbia University, expressed her astonishment at the prescription of melatonin to treat insomnia for more than a year, stressing that in the United States melatonin is not prescribed to treat insomnia, but rather it is a nutritional supplement that should be used with caution.

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She pointed out that the study has important limitations, including that the researchers did not know the locations of the participants, which may lead to incorrect classification of those who bought melatonin without a prescription and it was not recorded in their records. The severity of insomnia and accompanying psychological disorders may affect the results.

Dr. Ekenidelechukwu Nadi, the lead author of the study, confirmed that the results raise concerns about the safety of melatonin, but stressed that the study is observational and does not prove a direct causal relationship, calling for more research to confirm the cardiac safety of melatonin.