A large-scale American study links long-term melatonin use to an increased risk of heart failure. Here’s what researchers found – and what Consider know if you accept it regularly.
Warning Signals from a Study of 130,000 Patients
What the Study Shows (and Doesn’t Prove)
Specifically, the observational study revealed:
Control Group No Melatonin
Heart Failure over 5 years (association)
2.7%
Hospitalization for Heart Failure (association)
6.6%
All-Cause Mortality (association)
4.3%
Melatonin Group Use ≥ 1 year
Heart Failure over 5 years (association)
4.6% (+89%)
Hospitalization for Heart Failure (association)
19% (×3.5)
All-Cause Mortality (association)
7.8% (×1.8)
It’s important to note that Here’s a statistical association, not a proven cause-and-effect relationship. The study’s results have not yet been published in a peer-reviewed scientific journal.
Who is Most Exposed to This Potential Risk?
Seniors are the primary users. As people age, natural melatonin production declines in some individuals, leading many to turn to supplements to improve sleep. Some take them every night for months, or even years—without medical supervision. This proves this prolonged use that is associated with the risk observed in the study.
The Real Effectiveness of Melatonin is More Modest Than Believed
Seniors are the primary users. As people age, natural melatonin production declines in some individuals, leading many to turn to supplements to improve sleep. Some take them every night for months, or even years—without medical supervision. It is this prolonged use that is associated with the risk observed in the study.
What You Can Do Now
Short-Term Short-Course Use
Effectiveness on Sleep Onset
Modest but Recognized (EFSA, Inserm)
Identified Cardiac Risk
No Signal to Date
Long-Term Use ≥ 1 year
Effectiveness on Nighttime Awakenings
Little Demonstrated Effect (Inserm)
Cardiac Risk (association)
+89% Heart Failure (2025 AHA Study)
In other words, many French individuals are taking a product with modest effectiveness for extended periods, believing it to be completely harmless. However, the ANSES already recommended in 2018 limiting use to short-term applications and avoiding prolonged self-medication.
This American study does not invalidate the occasional use of melatonin. But it underscores that a “natural” supplement is not necessarily risk-free when taken long-term, especially in people with cardiovascular risk factors.
The Trap of “Natural Means Safe”
Researchers acknowledge several limitations to their work. Chronic insomnia itself is a cardiovascular risk factor. Depression, anxiety, or the use of other medications could likewise explain some of the results. But the signal is considered concerning enough to warrant increased caution.
One question remains unanswered: will this association be confirmed by more in-depth studies? Currently, no country has changed its regulations. But vigilance is advised—especially among those over 50 who have been taking this supplement daily for a long time.
Key Takeaways
- A large American study of 130,000 insomnia sufferers associates long-term melatonin use (≥1 year) with an increased risk of heart failure (+89%), but does not establish a causal link.
- Hospitalizations for heart failure were 3.5 times more frequent among long-term users.
- The effectiveness of over-the-counter melatonin supplements remains modest, according to Inserm, particularly for nighttime awakenings.
- ANSES recommended in 2018 limiting use to short-term applications and consulting a doctor.
- If you take it regularly, talk to your doctor. Cognitive behavioral therapy for insomnia (CBT-I) remains the gold standard treatment for chronic insomnia.
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