Efficacy and Safety of Prolonged-Release Melatonin for Primary Insomnia in Elderly Patients

Abstract

Objective: Insomnia, a prevalent sleep disorder affecting the elderly, necessitates effective and safe treatment options. This study explores the potential of the prolonged-release melatonin (Circadin<sup>®</sup>) addressing insomnia in elderly patients.Methods: The 8-week prospective observational study involved 115 participants, assessing sleep parameters using the Pittsburgh Sleep Quality Index (PSQI) and WHO-5 Well-being Index. The prolonged-release melatonin (2 mg) was administered nightly, and assessments were conducted at baseline, 4 weeks, and 8 weeks.Results: Both per protocol and last observation carried forward (LOCF) analyses consistently revealed significant improvements in sleep latency, total sleep time, sleep efficiency, and overall well-being. Notably, sleep latency decreased after 4 and 8 weeks, while total sleep time and sleep efficiency increased, reflecting longer and more restful sleep. The WHO-5 Well-being Index exhibited noticeable enhancement. Adverse events, including dizziness and heartburn, were manageable. Despite a high dropout rate, this drug’s potential as an efficacious and safe treatment option for elderly insomnia patients was evident, aligned with prior research.Conclusion: The prolonged-release formulation’s resemblance to the natural circadian rhythm of melatonin release offers advantages over conventional medications. This study contributes to understanding the prolonged-release melatonin’s promise as a valuable therapeutic alternative, encouraging further investigation into its longterm effects and optimal implementation.