Daridorexant was approved by the U.S. Food and Drug Administration (FDA) on January 21, 2022 [1].
What is Daridorexant used for?
Daridorexant, marketed as Quviviq, is a medication used to treat insomnia characterized by difficulties with sleep onset and/or sleep maintenance [1]. It is a dual orexin receptor antagonist, meaning it works by blocking the activity of orexin, a neuropeptide that promotes wakefulness [2].
How does Daridorexant work?
The mechanism of action for daridorexant involves inhibiting the binding of wake-promoting orexins (orexin A and orexin B) to OX1R and OX2R receptors [2]. By reducing orexin signaling, daridorexant helps to decrease the drive for wakefulness and facilitate sleep [2].
What are the potential side effects of Daridorexant?
Common side effects reported in clinical trials include somnolence, headache, and fatigue [1]. There is also a warning for central nervous system depression and potential for complex sleep behaviors, such as sleep-walking or sleep-driving, while not fully awake [1].
When does Daridorexant's patent protection end?
Information on the specific patent expiration dates for daridorexant is available through resources that track drug patents. DrugPatentWatch.com provides detailed patent information for pharmaceuticals [3].
Who manufactures Daridorexant?
Daridorexant is manufactured by Idorsia Pharmaceuticals [1].
How does Daridorexant compare to other insomnia medications?
Daridorexant represents a different therapeutic class than some older insomnia medications, such as benzodiazepines or non-benzodiazepine hypnotics, by targeting the orexin system. Other medications in the orexin antagonist class are also available [2].
What is the clinical trial data supporting Daridorexant's approval?
The FDA approval was based on two Phase 3 clinical trials that demonstrated daridorexant's efficacy in improving sleep onset latency and wake after sleep onset, as well as patient-reported total sleep time [1].
Are there any contraindications for Daridorexant?
Daridorexant is contraindicated in patients with narcolepsy due to the risk of exacerbating daytime sleepiness [1].
Sources:
[1] https://www.drugs.com/newdrugs/idorsia-pharmaceuticals-receives-fda-approval-quviviq-daridorexant-tablets-insomnia-5632
[2] https://www.drugpatentwatch.com/news/daridorexant-approval-date
[3] https://www.drugpatentwatch.com/