Daridorexant (Quviviq™) is a useful option for the treatment of insomnia disorder, which has shown efficacy in younger and older adults. It antagonises the orexin receptors, thereby reducing the wake drive. Daridorexant is the first dual orexin receptor antagonist to be approved for the treatment of chronic insomnia in the EU and has been approved for insomnia in the USA. In phase 3 clinical trials, daridorexant dose-dependently improved objective latency to persistent sleep, objective wake time after sleep onset, subjective total sleep time and, at the 50 mg dose, subjective daytime functioning compared with placebo. Daridorexant was generally well tolerated. Adverse events (AEs) commonly associated with insomnia drugs, such as somnolence, fatigue and dizziness, occurred at a similar or slightly greater frequency with daridorexant than with placebo. Falls occurred at a similar or lower frequency with daridorexant than with placebo. Most AEs were mild in severity and the incidence was not dose-dependent. The efficacy of daridorexant was maintained during a 12-month extension trial, with no new safety or tolerability concerns.
Insomnia disorder is characterized by persistent difficulty falling asleep and/or maintaining sleep and impaired daytime functioning. Dual orexin receptor antagonists suppress wakefulness and are generally considered to have a favourable safety profile compared with older classes of insomnia drugs, including less risk of tolerance, dependence, abuse and withdrawal effects. Daridorexant (Quviviq™) is the first dual orexin receptor antagonist approved for the treatment of chronic insomnia in the EU and has been approved for insomnia in the USA. In clinical trials, daridorexant improved objective sleep onset, objective sleep maintenance and self-reported total sleep time, and self-reported daytime functioning at a 50 mg dose. Daridorexant was generally well tolerated, with a low incidence of adverse events such as sleepiness, fatigue, dizziness and falls, most of which were similar to that with placebo. The efficacy and tolerability of daridorexant were sustained for 12 months. With a favourable safety profile compared to other classes of insomnia drugs, minimal residual next-morning effects and improvements in daytime functioning, daridorexant is a useful option for the treatment of insomnia disorder.
© 2023. Springer Nature.