The Use of Melatonin for Delirium Prevention in Medically Hospitalized Patients

Summary

The high prevalence of delirium in hospitalized older adults, with significant associated morbidity and mortality, emphasize the need for effective prevention strategies. Limited trials have explored melatonin's potential in preventing delirium among patients admitted to general medical wards. Previous trials on melatonin's preventive role in medical wards had limitations, necessitating a robust, double-blinded, placebo-controlled design with a larger sample size. This randomized, double-blind study of melatonin versus placebo aims to investigate the efficacy of melatonin, a neurohormone regulating the sleep-wake cycle, in preventing delirium among medically hospitalized patients aged 65 or older. Given the high prevalence of delirium in this population and its association with adverse outcomes, the study seeks to contribute valuable insights into an effective preventive strategy.

Timeline

Start

2024-09-30

Primary completion

2025-03

Completion

2025-06

Publications

• Background Riviere J, van der Mast RC, Vandenberghe J, Van Den Eede F. Efficacy and Tolerability of Atypical Antipsychotics in the Treatment of Delirium: A Systematic Review of the Literature. Psychosomatics. 2019 Jan-Feb;60(1):18-26. doi: 10.1016/j.psym.2018.05.011. Epub 2018 May 31.
• Background Shen YZ, Peng K, Zhang J, Meng XW, Ji FH. Effects of Haloperidol on Delirium in Adult Patients: A Systematic Review and Meta-Analysis. Med Princ Pract. 2018;27(3):250-259. doi: 10.1159/000488243. Epub 2018 Mar 8.
• Background Burton JK, Craig LE, Yong SQ, Siddiqi N, Teale EA, Woodhouse R, Barugh AJ, Shepherd AM, Brunton A, Freeman SC, Sutton AJ, Quinn TJ. Non-pharmacological interventions for preventing delirium in hospitalised non-ICU patients. Cochrane Database Syst Rev. 2021 Jul 19;7(7):CD013307. doi: 10.1002/14651858.CD013307.pub2.
• Background Al Huraizi AR, Al-Maqbali JS, Al Farsi RS, Al Zeedy K, Al-Saadi T, Al-Hamadani N, Al Alawi AM. Delirium and Its Association with Short- and Long-Term Health Outcomes in Medically Admitted Patients: A Prospective Study. J Clin Med. 2023 Aug 17;12(16):5346. doi: 10.3390/jcm12165346.
• Background Goldberg TE, Chen C, Wang Y, Jung E, Swanson A, Ing C, Garcia PS, Whittington RA, Moitra V. Association of Delirium With Long-term Cognitive Decline: A Meta-analysis. JAMA Neurol. 2020 Nov 1;77(11):1373-1381. doi: 10.1001/jamaneurol.2020.2273.
• Background Lozano-Vicario L, Garcia-Hermoso A, Cedeno-Veloz BA, Fernandez-Irigoyen J, Santamaria E, Romero-Ortuno R, Zambom-Ferraresi F, Saez de Asteasu ML, Munoz-Vazquez AJ, Izquierdo M, Martinez-Velilla N. Biomarkers of delirium risk in older adults: a systematic review and meta-analysis. Front Aging Neurosci. 2023 May 12;15:1174644. doi: 10.3389/fnagi.2023.1174644. eCollection 2023.
• Background Wang CG, Qin YF, Wan X, Song LC, Li ZJ, Li H. Incidence and risk factors of postoperative delirium in the elderly patients with hip fracture. J Orthop Surg Res. 2018 Jul 27;13(1):186. doi: 10.1186/s13018-018-0897-8.
• Background Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
• Background Chin YC, Koh GC, Tay YK, Tan CH, Merchant RA. Underdiagnosis of delirium on admission and prediction of patients who will develop delirium during their inpatient stay: a pilot study. Singapore Med J. 2016 Jan;57(1):18-21. doi: 10.11622/smedj.2016007.
• Al Alawi AM, Al Busaidi S, Al Rasbi SK, Al Farsi RS, Al Zeedy K, Al Huraizi AR, Al-Maqbali JS. Effect of melatonin versus placebo for the prevention of delirium among medically hospitalised older patients: a double-blinded randomised controlled trial (project RESTORE). BMJ Open. 2026 Jan 27;16(1):e107775. doi: 10.1136/bmjopen-2025-107775.
• Al-Maqbali JS, Al-Busaidi S, Al Farsi RS, Al Rasbi S, Al Zeedy K, Al Huraizi AR, Al Alawi AM. Effect of melatonin versus placebo for prevention of delirium among medically hospitalised patients: study protocol for a single-centre, double-blinded, randomised controlled trial (project RESTORE). BMJ Open. 2025 Feb 25;15(2):e094195. doi: 10.1136/bmjopen-2024-094195.

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