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Ramelteon Reduces Risk of Delirium in Hospitalized Patients


Clinical question

Does ramelteon, a melatonin agonist, prevent delirium in hospitalized patients?

Bottom line

In this small, single-blinded study, ramelteon was shown to be effective in preventing delirium in elderly patients who required hospitalization for acute illness. You would have to treat 3 patients with ramelteon to prevent one episode of delirium. (LOE = 1b)


Hatta K, Kishi Y, Wada K, et al, for the DELIRIA-J Group. Preventive effects of ramelteon on delirium. JAMA Psychiatry 2014;71(4):397-403.

Study design

Randomized controlled trial (single-blinded)

Funding source





Inpatient (any location)


Using concealed allocation, these investigators randomized 67 hospitalized patients (24 admitted to intensive care units, 43 admitted to general wards) to receive either ramelteon 8 mg or placebo nightly up to 7 days or until the onset of delirium. Eligible patients were 65 years to 89 years old, were admitted to the hospital via the emergency department, were able to take oral medications, and had an expected length of stay of greater than 48 hours. Patients with psychiatric disorders, severe liver disease, Lewy body disease, or alcohol dependency were excluded. Nurses provided similar delirium prevention care to all patients, including frequent reorientation, adequate lighting, and noise reduction. If patients required treatment for insomnia, hydroxyzine was used with a dose limit of 25 mg per night. Baseline characteristics were similar in the 2 groups, with a mean age of 78 years. For the primary outcome of onset of delirium, experienced psychiatrists, masked to study group, assessed patients in the mornings and afternoons for up to 7 days using a delirium rating scale. Only 1 patient in the ramelteon group was diagnosed with delirium as compared with 11 patients in the placebo group (3% vs 32%; number needed to treat = 3; P = .003). Interestingly, there were no significant differences between the groups in sleep metrics such as difficulty falling asleep and poor sleep quality, although the sample was likely too small to detect such differences. Note that the patients were not masked in this study, which could have potentially affected the overall outcomes. No adverse effects attributed to the study drug were reported.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

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