Daridorexant for Delirium

This trial tests a drug called daridorexant to determine if it can prevent delirium (a sudden state of confusion) and improve sleep quality after heart surgery. Participants will receive either daridorexant or a placebo (a harmless pill with no effect) for the first three nights post-surgery, and researchers will monitor daily changes in sleep and delirium symptoms. The trial also explores using pre-surgery voice recordings to predict delirium risk. It is designed for individuals aged 60 or older undergoing certain types of heart surgery who can communicate in English. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use a prescription sleep aid regularly or a strong CYP3A4 inhibitor (a type of drug that affects how your body processes certain medications).

Research has shown that daridorexant, a drug tested to prevent confusion after heart surgery, has been studied in other trials for safety and effectiveness. Participants generally tolerated daridorexant well, with most side effects being mild, such as headaches or dizziness. These studies reported no serious problems directly linked to the drug. Since daridorexant is already approved for other uses, such as treating insomnia, some safety information is available. This suggests it is likely safe, but ongoing studies will provide more detailed information.¹²³⁴⁵

Daridorexant is unique because it targets delirium with a new mechanism of action. Most treatments for delirium focus on managing symptoms using antipsychotics or sedatives. However, daridorexant works by modulating the orexin system, which is involved in regulating sleep and wakefulness. This approach could potentially address the underlying causes of delirium, particularly after heart surgery, making it an exciting option for researchers looking to improve patient outcomes.

This trial will compare daridorexant with a placebo to evaluate its effects on delirium after heart surgery. Research has shown that daridorexant, a medication that helps manage sleep, might reduce symptoms of delirium and improve sleep quality post-surgery. Early results from a trial showed promise in preventing delirium. Studies suggest that daridorexant can lessen the severity of delirium, a sudden and severe confusion often occurring after surgery. Although data on daridorexant specifically for delirium remains limited, its ability to improve sleep suggests potential benefits, as better sleep can help reduce the risk of delirium.¹²³⁶⁷