New health warning issued over popular sleep aid millions take nightly

Melatonin supplements have grown in popularity for promoting higher-quality sleep.

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

But new research has linked long-term melatonin use with 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 one year. The other half did not take the supplement.

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

The study found that long-term melatonin use in those with chronic insomnia was linked with a 90% increased chance of incident heart failure. (iStock)

The researchers found that long-term melatonin use in those with chronic insomnia was linked to a 90% increased chance of incident 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 with 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 nearly 3.5 times as likely to be hospitalized for heart failure and twice as likely to die.

Heart failure is a common condition that affects 6.7 million U.S. adults, which occurs when the heart cannot pump enough blood to the organs for proper function, according to the AHA.

Melatonin is available for over-the-counter use in the U.S., yet is only available as prescribed in other countries. (istock)

Ekenedilichukwu Nnadi, M.D., 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 commonly assumed."

"Melatonin supplements are widely thought of as a safe and natural option to support better sleep, so it was striking to see such consistent and significant increases in serious health outcomes, even after balancing for many other risk factors," he said.

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"If our study is confirmed, this could affect how doctors counsel patients about sleep aids."

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

"It was striking to see such consistent and significant increases in serious health outcomes."

"Worse insomnia, depression/anxiety or the use of other sleep-enhancing medicines might be linked to both melatonin use and heart risk," Nnadi said. "Also, while the association we found raises safety concerns about the widely used supplement, our study cannot prove a direct cause-and-effect relationship."

"This means more research is needed to test melatonin’s safety for the heart."

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

Wendy Troxel, Ph.D., senior scientist at the RAND Corporation and author of "Sharing the Covers: Every Couple’s Guide to Better Sleep," called this study an "important wake-up call" for consumers and healthcare providers.

"In the U.S., melatonin is widely promoted and easily purchased over the counter," the Utah-based expert told Fox 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’s a "huge variability" in the dose and potency of melatonin supplements, as what is found in a pill or a gummy can differ "dramatically" from what’s on the label.

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

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

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

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

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

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"[This] can be particularly tempting for little ones when they are packaged as gummies," she warned.

Instead of turning to supplements, Troxel encourages people to seek treatments that have "proven long-term benefits," like cognitive behavioral therapy for insomnia.

This structured behavioral intervention "consistently yields better and more lasting results" than medication, according to the doctor.

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

In a Monday press release, the Council for Responsible Nutrition (CRN) reacted to the study findings linking long-term melatonin to heart disease risk, urging "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 statement read.

The organization also noted that individuals 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 use melatonin dietary supplements occasionally for sleep support."

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In 2024, CRN implemented melatonin labeling guidelines that recommend upper dosage levels and include advisory statements such as "For occasional and/or intermittent use only" and "Consult a healthcare professional if you are experiencing long-term sleep difficulties," the release noted.

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