Overview
- An observational analysis presented at an American Heart Association meeting compared UK and US health records for about 65,000 adults with insomnia who were prescribed melatonin against non-users.
- Researchers reported an 89% higher five-year risk of hospitalization for heart failure among those prescribed melatonin compared with the control group.
- Experts stress the findings show an association rather than causation and recommend replication studies and randomized trials before drawing safety conclusions.
- Clinicians report extensive unsupervised use, including among children and adolescents, with uncertainty around appropriate dosing, timing, interactions and contraindications.
- In Spain, products under 2 mg are sold without prescription and higher doses are regulated as medicines; the national regulator lists numerous possible adverse effects and some specialists want EMA-reviewed warnings and tighter access.