New health warning issued about popular sleep aid that millions of people take every night

Melatonin supplements have gained popularity for promoting higher quality sleep.

Melatonin is a hormone produced naturally in the body that helps regulate sleep, increasing during hours of darkness and decreasing with exposure to daylight. The supplements are widely available for over-the-counter use, particularly in the US.

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 medical records of 130,828 adults with insomnia, half of whom took melatonin for at least a year. The other half did not take the supplement.

People who were prescribed other sleep medications or who already had confirmed heart failure were excluded from the analysis.

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

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

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A secondary analysis revealed that participants who took melatonin were almost 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 to function properly, according to the AHA.

Ekenedilichukwu Nnadi, MD, lead author of the study and chief resident of 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 commonly assumed.”

“Melatonin supplements are widely considered a safe and natural option to support better sleep, so it was surprising to see such consistent and significant increases in serious health outcomes, even after balancing many other risk factors,” he said.

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“If our study is confirmed, this could affect how doctors advise patients about sleep aids.”

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

“It was surprising to see such consistent and significant increases in serious health outcomes.”

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

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

Wendy Troxel, Ph.D., senior scientist at the RAND Corporation and author of “Sharing the Cover: Every Couple’s Guide to Better Sleep,” called this 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 News Digital. “Many people assume that just because it’s natural, it must be safe and effective, but that’s not necessarily the case.”

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Troxel said there is “enormous variability” in the dosage and potency of melatonin supplements, as what is found in a pill or gummy can differ “drastically” from what is on the label.

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

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“It’s also important to note that melatonin doesn’t actually help you sleep in the traditional sense,” Troxel noted. “Rather, it’s a chronobiotic, meaning it helps tell the body when it’s time to sleep, but it 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,” he added.

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

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“[This] can be particularly tempting to little ones when packaged in gummy form,” he warned.

Instead of turning to supplements, Troxel encourages people to look for 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 medication, according to the doctor.

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

“This research represents initial, 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 statement 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 dietary supplements to aid sleep.”

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

Experts recommend that consumers consult with their healthcare providers before adding melatonin to their regimen.