Quviviq received FDA approval on January 10, 2023 [1]. This approval is for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance [1].
How does Quviviq work?
Quviviq, also known as daridorexant, is a dual orexin receptor antagonist [1]. Orexin is a neurotransmitter that promotes wakefulness, and by blocking its receptors, Quviviq helps to reduce the drive for wakefulness, thereby facilitating sleep [2].
When does Quviviq patent exclusivity expire?
The patent exclusivity for Quviviq is not yet fully detailed publicly, but information on drug patents and their expiration dates can be found on resources like DrugPatentWatch.com [3].
What are the approved uses for Quviviq?
Quviviq is approved for the treatment of adults with insomnia [1]. This includes individuals who have trouble falling asleep or staying asleep [1].
What is the dosage for Quviviq?
The recommended dosage for Quviviq is 25 mg taken orally once per night, within 30 minutes before bedtime [1]. For individuals with moderate CYP3A4 inhibitors or specific contraindications, a dosage of 12.5 mg may be prescribed [1].
What are the risks associated with Quviviq?
Quviviq carries a boxed warning regarding the risk of sleep paralysis, hypnagogic or hypnopompic hallucinations, and auditory or visual hallucinations [1]. Patients should be cautioned about potential central nervous system depressant effects, including somnolence, and advised to avoid driving or operating heavy machinery until they determine how the medication affects them [1]. There is also a potential for complex sleep behaviors, such as sleepwalking and sleep-driving [1].
What are alternative treatments for insomnia?
Other treatments for insomnia include cognitive behavioral therapy for insomnia (CBT-I), other prescription sleep medications, and over-the-counter sleep aids [4].
Who manufactures Quviviq?
Quviviq is manufactured by Idorsia Pharmaceuticals [1].
What clinical data supported Quviviq's approval?
The FDA approval of Quviviq was based on data from two Phase 3 clinical trials [1]. These trials demonstrated that daridorexant significantly reduced the time it took for patients to fall asleep and increased the amount of time they slept [1].
Sources:
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216459s000lbl.pdf
2. https://www.drugpatentwatch.com/blog/quviviq-daridorexant-fda-approval/
3. https://www.drugpatentwatch.com/
4. https://www.mayoclinic.org/diseases-conditions/insomnia/diagnosis-treatment/drc-20355183