February 24, 2014
By David Douglas
NEW YORK - Ramelteon appears to greatly reduce the risk of delirium in elderly patients following hospital admission for acute care, according to Japanese researchers.
The incidence of delirium during hospitalization is as high as 56% among elderly patients, the authors note in a February 19th online paper in JAMA Psychiatry.
Dr. Kotaro Hatta of Juntendo University Nerima Hospital, Tokyo and colleagues say melatonin has shown promise against the risk of delirium. They hoped that ramelteon, a melatonin agonist, might also be of value. The agent is FDA approved to treat insomnia and might avoid the adverse effects of antipsychotics, which have also shown some benefit.
The researchers studied 67 patients aged 65 to 89 years who were newly admitted to one of five hospitals due to serious medical problems, but were able to take medicine orally. Of these patients, 24 were admitted to intensive care units and 43 admitted to regular wards. They were randomized to 8 mg of ramelteon or placebo daily for a week.
Use of ramelteon was associated with a significant reduction in risk of delirium (3% vs 32%), giving a relative risk of 0.09. Even after controlling for risk factors such as age and a diagnosis of dementia, ramelteon was still associated with a lower incidence of delirium (odds ratio, 0.07).
The team also estimated the time to development of delirium as 6.94 days in the active treatment group and 5.74 days in placebo patients.
The researchers go on to point out that a strong decline in melatonin levels during aging has been consistently reported by many investigators. In particular, they say, abnormalities "mediated by melatonin neurotransmission might be clinically important, particularly for delirium prevention."
"Ramelteon administered nightly to elderly patients admitted for acute care may provide protection against delirium," they conclude, while still calling for further study.
Commenting on the findings by email, Dr. Sophia E. de Rooij of the University of Amsterdam, co-author of an editorial on the paper, agrees with the need for further study but is enthusiastic about the approach. "I am convinced," she said, "that this introduction of a new and safe prophylactic therapy against delirium, a devastating complication of acute illness especially among older hospital patients, is a major contribution to the prevention of delirium and perhaps also from its sequelae like dementia."
In fact, Dr. de Rooij added, "The results of this study might also introduce the end of the use of antipsychotics in vulnerable patient groups."
Ramelteon is marketed as Rozerem in the U.S.
Dr. Hatta did not respond to requests for comments. The authors declared they had no conflicts of interest.
JAMA Psychiatry 2014.
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