Researchers have found that long-term use of melatonin supplements is associated with an increased risk of heart failure, hospitalization due to heart failure, and death from any cause in people with chronic insomnia.
Although the results do not prove that melatonin itself is the cause of these risks, they do raise new questions about the safety of a supplement often seen as a "natural" and safe option for improving sleep.
Melatonin is a hormone produced by the pineal gland in the brain, and it helps regulate the sleep-wake cycle (circadian rhythm).
Its levels rise in the dark and fall during the day. Synthetic melatonin is available without a prescription in many countries where supplements are not strictly regulated, meaning their strength and purity vary between brands.
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 TriNetX global network of electronic health records.
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 one year, with the two groups matched for age, sex, race, disease, medication 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 within the next five years, with heart failure occurring in 4.6% of the melatonin group versus 2.7% in the comparison group.
When analyzing a group that met the requirement of dispensing melatonin prescriptions twice with at least a 90-day interval, the association remained, with a higher risk of 82%.
Hospital admissions due to heart failure were also about 3.5 times higher in the melatonin group (19.0% vs. 6.6%), and deaths from any cause were also more common, at 7.8% vs. 4.3%, meaning the risk was almost double.
Dr. Marie-Pierre St-Onge, a sleep researcher at Columbia University, expressed surprise at the prescription of melatonin for insomnia treatment for more than a year, stressing that in the United States melatonin is not prescribed for insomnia treatment, but is a dietary supplement that should be used with caution.
She noted that the study had significant limitations, including the fact that the researchers did not know the participants' locations, which could lead to misclassification of those who purchased melatonin without a prescription and whose records were not kept. The severity of insomnia and any accompanying psychological disturbances could also affect the results.
Dr. Ekenedilchoko Nadi, the lead author of the study, confirmed that the results raise concerns about the safety of melatonin, but stressed that the study was observational and did not prove a direct causal relationship, calling for more research to confirm the cardiac safety of melatonin.
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