Suvorexant for Delirium: Phase 3 Results

TOPLINE:
Treatment with suvorexant was associated with a lower incidence of delirium in hospitalized older adults compared with placebo, but the difference was not statistically significant. However, the drug was associated with significantly less delirium in patients with mild dementia and those with hyperactive or mixed delirium.
METHODOLOGY:  
Researchers conducted a double-blind, placebo-controlled, phase 3 randomized clinical trial of hospitalized adults aged 65-90 years at high risk for delirium at 50 hospitals in Japan between 2020 and 2022.
A total of 203 patients (mean age, 81.7 years; 52.2% women) received suvorexant (15 mg) or placebo at bedtime for up to 7 days.
The primary outcome was the incidence of delirium, diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria.
TAKEAWAY:  
The incidence of delirium was not significantly different in the suvorexant group vs placebo (16.8% vs 26.5%; P = .13).
In a subgroup of 88 patients with mild dementia, suvorexant was associated with a significantly lower incidence of dementia (22.9% vs 45.0%; difference, -22.1% [95% CI, -40.8% to -2.2%]).
Suvorexant was also linked to significantly lower delirium rates than was placebo in a post hoc analysis of patients with hyperactive plus mixed subtypes of dementia (10.9% vs 21.6%; P = .04).
One death (due to urosepsis) occurred in the suvorexant group but was not considered drug-related; adverse events were similar between groups.
IN PRACTICE:
“Fewer participants taking suvorexant had delirium compared with placebo but the difference was not statistically significant. Further studies are needed to determine whether suvorexant may be useful for reducing delirium—particularly delirium with a hyperactive component,” the authors wrote.
SOURCE:
The study, led by Kotaro Hatta, MD, PhD, Juntendo University Nerima Hospital, Tokyo, Japan, was published online on August 16 in JAMA Network Open.
LIMITATIONS: 
The trial was conducted exclusively in Japan, which may limit generalizability of the findings to other populations and settings. The majority of the participants had mild cognitive impairment or mild dementia, which may also limit generalizability. The evaluated dose of suvorexant was lower than the maximum dose approved in the United States and some other countries. Finally, the analysis by delirium subtype was post hoc and exploratory.
DISCLOSURES:
This study was funded by MSD K.K. and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co Inc. Five authors reported employment with study sponsors. The authors received personal fees, grants, and honoraria outside this work. Full disclosures are available in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
 
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