Melatonin and Sleep in Preventing Delirium in the Hospital (MELO)

Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are given the supplement. This pilot study involves a randomized placebo-controlled design in which participants will be randomized to receive either melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep questionnaire each morning to obtain subjective data on their sleep quality overnight. Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method (CAM).

Primary outcome is whether patients become delirious, as measured by CAM during their hospital admission.

Delirium assessments will be made twice daily (am and pm measurements) throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.

nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.

nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.

nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.

Patients will be asked to fill out the Richards-Campbell sleep question, which uses a visual analog scale for 5 questions that are designed to assess a patient's perceived sleep quality.

once daily, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.

We want to determine if the patient is discharged to home, to a post-acute care facility, or to a new type of living facility that was different from their prior living situation.

Inclusion Criteria: 65-100 years old Admitted to Scripps Green Hospital Admitted to an Internal Medicine or Medicine Consult Service Expected to have a hospital stay of greater than or equal to 48 hours (patients admitted to "inpatient," not "observation," under Medicare guidelines) Exclusion Criteria: Cirrhosis of any etiology Admitted for alcohol withdrawal Currently taking a 1st or 2nd generation anti-psychotic Active delirium (i.e., delirium prior to 1st dose of melatonin) Diagnosis of encephalitis History of seizure

Jaiswal SJ, Kang DY, Wineinger NE, Owens RL. Objectively measured sleep fragmentation is associated with incident delirium in older hospitalized patients: Analysis of data collected from an randomized controlled trial. J Sleep Res. 2021 Jun;30(3):e13205. doi: 10.1111/jsr.13205. Epub 2020 Oct 13.

Jaiswal SJ, McCarthy TJ, Wineinger NE, Kang DY, Song J, Garcia S, van Niekerk CJ, Lu CY, Loeks M, Owens RL. Melatonin and Sleep in Preventing Hospitalized Delirium: A Randomized Clinical Trial. Am J Med. 2018 Sep;131(9):1110-1117.e4. doi: 10.1016/j.amjmed.2018.04.009. Epub 2018 May 3.