Similarly, doubled risk for all-cause mortality seen during five-year study period
By Lori Solomon HealthDay Reporter
THURSDAY, Nov. 6, 2025 (HealthDay News) — Long-term melatonin use for treatment of insomnia is associated with a higher risk for incident heart failure and all-cause mortality, according to a study to be presented at the American Heart Association Scientific Sessions 2025, being held from Nov. 7 to 10 in New Orleans.
Ekenedilichukwu Nnadi, M.D., from SUNY Downstate/Kings County Primary Care in Brooklyn, New York, and colleagues queried the TriNetX Global Research Network to compare long-term cardiovascular safety in adults with insomnia and at least one melatonin prescription and ≥365 exposure-days versus those not exposed to melatonin. The analysis included 65,414 melatonin users and 65,414 controls matched for demographics, 15 comorbidities, concomitant cardiometabolic drugs, laboratories, vitals, and health care utilization.
The researchers found that during five years of follow-up, incident heart failure occurred in 3,021 melatonin users (4.6 percent) versus 1,797 controls (2.7 percent; hazard ratio [HR], 1.89). A similar trend was seen for heart failure-related hospitalization, which occurred in 12,411 users (19.0 percent) and 4,309 controls (6.6 percent; HR, 3.44). Additionally, all-cause mortality was higher in melatonin users (7.8 versus 4.3 percent; HR, 2.09). Similar results were seen when the analysis was limited to two or more melatonin fills ≥90 days apart (HR for heart failure, 1.82).
“Melatonin supplements may not be as harmless as commonly assumed,” Nnadi said in a statement. “If our study is confirmed, this could affect how doctors counsel patients about sleep aids.”
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