Suvorexant 085
Trial question
What is the role of suvorexant in older adults at high risk for delirium after hospitalization?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 203
203 patients (106 female, 97 male).
Inclusion criteria: older adults at high risk for delirium after hospitalization.
Key exclusion criteria: development of delirium during the screening period; current use of psychotropic drugs; history of drug or alcohol abuse; excessively severe physical disease for 2 weeks before randomization; history of epilepsy or Parkinson's disease; moderate or severe dementia.
Interventions
N=101 suvorexant (at a dose of 15 mg/day for 5-7 days).
N=102 placebo (matching placebo daily for 5-7 days).
Primary outcome
Delirium as assessed by Diagnostic and Statistical Manual of Mental Disorders / Fifth Edition
16.8%
26.5%
26.5 %
19.9 %
13.3 %
6.6 %
0.0 %
Suvorexant
Placebo
No significant
difference ↔
No significant difference in delirium as assessed by DSM-5 (16.8% vs. 26.5%; ARD -8.7, 95% CI -20.1 to 2.6).
Secondary outcomes
No significant difference in delirium as assessed by Delirium Rating Scale-Revised-98 (17.8% vs. 26.5%; ARD -8.6, 95% CI -20.2 to 2.8).
No significant difference in median delirium severity as assessed by Delirium Rating Scale-Revised-98 (7 points vs. 7.5 points; AD -0.5 points, 95% CI -2 to 1).
Significant decrease in hyperactive plus mixed subtypes of delirium (10.9% vs. 21.6%; ARD -10.7, 95% CI -21.2 to -0.6).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In older adults at high risk for delirium after hospitalization, suvorexant was not superior to placebo with respect to delirium as assessed by DSM-5.
Reference
Kotaro Hatta, Yasuhiro Kishi, Ken Wada et al. Suvorexant for Reduction of Delirium in Older Adults After Hospitalization: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2427691.
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