Melatonin for more than a year increases the chance of heart failure by 90%, reveals research in the USAPor Maria
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Study reveals association between prolonged use of melatonin and increased risk of heart failure in adults with insomnia. Researchers analyzed data from more than 130,000 patients in the TriNetX database, comparing users of the supplement for more than a year with non-users. The research, released by the American Heart Association, identified a 90% increase in the risk of being diagnosed with heart failure.
Participants who took melatonin had 4.6% rates of heart failure over five years, compared to 2.7% in non-users. The study considered factors such as age, sex, pre-existing conditions and medications. Results indicate the need for caution when consuming synthetic hormones.
- Risk of hospitalization due to heart failure was 3.5 times higher in users.
- General mortality reached 7.8% among policyholders, versus 4.3% among others.
- Analysis excluded patients with a previous history of heart problems.
Details of the methodology adopted
Researchers reviewed five years of medical records in an international database. The sample included 65,400 melatonin users with prescriptions separated by at least 90 days.
Comparisons controlled by demographic and health variables ensured balance. Exclusions included individuals using other sleep aids or previous diagnoses of insufficiency.
Hospitalization and mortality rates
Melatonin users recorded 19% of hospitalizations for heart problems in five years. Non-users had a rate of 6.6% in the same period.
Risk of death from any cause almost doubled in the group exposed to the supplement. Adjusted data maintained consistency in observed associations.

Profile of participants involved
The average age of those studied was 55.7 years. Women represented 61.4% of the total sample.
Paired analyzes by gender, hypertension and nervous conditions reinforced results. Long-term use defined as greater than one year or multiple prescriptions.
Factors controlled in the analysis
Study considered race, ethnicity, body mass index and blood pressure. Medications for the heart or nervous system were also included in the adjustment.
Variables such as depression and anxiety were indirectly weighted via exclusions. Association remained significant after controls.
Limitations identified by authors
Research demonstrates correlation, not direct causation with melatonin. Severe insomnia cancontribute to cardiovascular risks independently.
Preliminary results await external peer review. Further investigations are recommended to clarify mechanisms involved.
In-Market Supplement Context
Melatonin regulates the sleep-wake cycle naturally in the pineal gland. Synthetic versions treat insomnia and jet lag in several countries.
In Brazil, the product is classified as a dietary supplement without the need for a prescription. Sales grow with search for solutions for sleep disorders.
Additional risks noted
Users with two or more prescriptions in 90 days had an 82% increased risk of heart failure. Hospitalizations due to cardiac complications predominated in the exposed group.
High mortality suggests monitoring in chronic consumers. Data is based on real global patient registries.







