Melatonin supplement linked to 90% higher risk of heart failure in new study

Melatonin supplements are growing in popularity to promote better quality sleep.

Melatonin is a hormone naturally produced in the body that helps regulate sleep, increasing during hours of darkness and decreasing with exposure to daylight. Supplements have become widely available over the counter, particularly in the United States.

But new research has linked long-term melatonin use to a significantly increased risk of heart failure, hospitalization and death.

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An observational study from the American Heart Association (AHA) examined five years of health records of 130,828 adults with insomnia, half of whom used melatonin for at least a year. The other half did not take the supplement.

People who had been prescribed other sleeping pills or who already had confirmed heart failure were excluded from the analysis.

The study found that long-term use of melatonin in people with chronic insomnia was associated with a 90% increase in the risk of heart failure. (iStock)

Researchers found that long-term melatonin use in people with chronic insomnia was linked to a 90% increased risk of heart failure compared to non-users.

Additionally, according to the observational study, participants who filled at least two prescriptions for melatonin at least 90 days apart had an 82% higher risk of developing heart failure than those who did not use melatonin.

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A secondary analysis found that participants taking melatonin were nearly 3.5 times more likely to be hospitalized for heart failure and twice as likely to die.

Heart failure is a common condition that affects 6.7 million American adults and occurs when the heart cannot pump enough blood to the organs for them to function properly, according to the AHA.

Melatonin is available over the counter in the United States, but is only available by prescription in other countries. (istock)

Ekenedilichukwu Nnadi, MD, lead author of the study and chief resident in internal medicine at SUNY Downstate/Kings County Primary Care in Brooklyn, New York, commented in a statement that melatonin supplements “may not be as harmless as is commonly assumed.”

“Melatonin supplements are widely considered a safe and natural option for promoting better sleep, so it was striking to see such a consistent and significant increase in serious health conditions, even after accounting for many other risk factors,” he said.

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“If our study is confirmed, it could affect how doctors advise patients about sleeping pills.”

The research posed several limitations, the researchers noted, including a lack of information about the severity of insomnia and the presence of other psychiatric disorders.

“It was striking to see such a consistent and significant increase in serious health problems.”

“More severe insomnia, depression/anxiety, or use of other sleep-enhancing medications could be linked to both melatonin use and cardiac risk,” Nnadi said. “Additionally, although the association we found raises safety concerns regarding the widely used supplement, our study cannot prove a direct cause-and-effect relationship.”

“This means that more research is needed to test the safety of melatonin for the heart.”

The most effective treatment for insomnia is cognitive behavioral therapy, according to an expert. (iStock)

Wendy Troxel, Ph.D., a senior scientist at the RAND Corporation and author of “Sharing the Blankets: Every Couple’s Guide to Better Sleep,” called the study an “important wake-up call” for consumers and health care providers.

“In the United States, melatonin is widely promoted and easily purchased without a prescription,” the Utah-based expert told Fox News Digital. “Many people assume that just because it’s natural that it must be safe and effective, but that’s not necessarily the case.”

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Troxel said there is “huge variability” in the dose and potency of melatonin supplements because what is found in a pill or gummy can differ “dramatically” from what is on the label.

The availability of 5 mg and 10 mg doses “defies logic,” she said, warning that the amount is “far greater than our bodies can produce naturally.”

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“It’s also important to note that melatonin is not actually a sleep aid in the traditional sense,” Troxel noted. “It’s more of a chronobiotic, meaning it helps signal your body when it’s time to sleep, but doesn’t necessarily put you to sleep.”

“Perhaps not surprisingly, studies consistently show little evidence that melatonin is truly effective as a nighttime sleep aid for most people with chronic insomnia,” she added.

Melatonin helps signal your body when it’s time to sleep, but doesn’t necessarily put you to sleep, one expert noted. (iStock)

Troxel pointed to existing data showing an increase in emergency room visits among children taking melatonin supplements who “accidentally overdosed.”

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“(It) can be especially tempting for toddlers when packaged as candy,” she warned.

Instead of turning to supplements, Troxel encourages people to seek out treatments that have “proven long-term benefits,” such as cognitive behavioral therapy for insomnia.

This structured behavioral intervention “consistently produces better and longer-lasting results” than medications, according to the doctor.

People who sleep poorly tend to have higher heart rates and blood pressure and experience more cardiovascular events, an industry organization noted. (iStock)

In a press release issued Monday, the Council for Responsible Nutrition (CRN) responded to study results linking long-term melatonin to heart disease risk, calling for “caution and context.”

“This research represents early, non-peer-reviewed data that cannot establish cause and effect. Chronic insomnia – a condition shared by all study participants – may itself be a contributing factor to heart health outcomes, raising more questions than answers,” the release read.

The organization also noted that people who sleep poorly tend to have higher heart rates and blood pressure and experience more cardiovascular events. “Therefore, these findings are unlikely to apply to healthy adults who occasionally use melatonin supplements to promote sleep.”

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In 2024, CRN implemented melatonin labeling guidelines that recommend higher dosage levels and include warnings such as “For occasional and/or intermittent use only” and “Consult a healthcare professional if you experience long-term sleep difficulties,” the release said.

Experts recommend that consumers consult their health care providers before adding melatonin to their regimen.