Melatonin, the darling of the sleep-deprived, is facing some uncomfortable scrutiny. A recent study presented at the American Heart Association's Scientific Sessions raises concerns about long-term usage. The headline? An 89% higher risk of heart failure among those prescribed melatonin for over a year, compared to those who weren't. Twice as likely to die from any cause, too. (Those are the kinds of numbers that make you sit up straight.)
The Numbers Under the Microscope
Now, before everyone throws out their sleep gummies, let's dissect this a bit. The study, which hasn't yet been peer-reviewed, analyzed over 130,000 adults across multiple countries. That's a decent sample size, but the devil, as always, is in the details. The researchers, led by Ekenedilichukwu Nnadi at SUNY Downstate, looked at prescription records to determine melatonin usage. That's where things get a little fuzzy.
Here's the rub: melatonin is available over-the-counter in the US. So, the control group – those not prescribed melatonin – could easily include people self-medicating without a doctor's note. This introduces a significant bias. As Carlos Egea from the Spanish Federation of Sleep Medicine Societies points out, this limitation challenges the perception of melatonin as a benign chronic therapy.
And the secondary analysis? Those on melatonin for over a year were almost 3.5 times as likely to be hospitalized for heart failure. The risk of dying jumped from 4.3% to 7.8%. Those are big percentage jumps, but you need to consider the base rates. A jump from 4.3% to 7.8% is a 3.5 percentage point increase. A 7.8% mortality rate is still relatively low, but the relative risk is high.
What's interesting is the difference between the US and the UK, where melatonin is prescription-only. The study included data from both countries. This suggests that the UK data (where usage is more tightly controlled) might be more reliable, but the study doesn't break down the results by country. (A missed opportunity, in my opinion.)

Correlation vs. Causation & Other Lingering Questions
The study highlights a correlation, not necessarily causation. Were these people already predisposed to heart issues? Were they taking other medications? Did they have underlying conditions that both caused insomnia and increased their risk of heart failure? We don't know. The study simply flags an association that warrants further investigation.
And this is the part of the report that I find genuinely puzzling: if the control group was contaminated by over-the-counter users, then the real risk of melatonin might be higher than the study suggests. It's like trying to measure the effect of a new fertilizer on crop yield, but some of the "control" plants are secretly getting the fertilizer too. You'd underestimate the effect.
The article also mentions non-fatal overdoses among children in Australia. Completely different issue, but it highlights the fact that "natural" doesn't equal "risk-free." Dosage matters, purity matters, and individual sensitivities matter.
So, what does all this mean? It means we need more data. We need prospective trials with proper control groups (i.e., no sneaky over-the-counter melatonin use). We need to understand the long-term effects of melatonin, especially as its popularity continues to surge. The current recommendations – short-term use (1-2 months) is generally safe – remain unchanged. But this study serves as a wake-up call.
And what about the impact of erectile dysfunction (ED) on heart health? While seemingly unrelated, a separate article highlights the connection between ED and underlying conditions like heart disease. Perhaps there's a link between sleep issues, melatonin use, and cardiovascular health that we're missing. The body, after all, is a complex system, not a collection of isolated parts.
