Quviviq, also known by its generic name daridorexant, is a medication approved in Europe for the treatment of insomnia. It functions by blocking the activity of orexin neuropeptides, which play a role in wakefulness. This mechanism helps to reduce sleep-wake drive, promoting sleep [1].
What is the regulatory status of Quviviq in Europe?
Quviviq received marketing authorization from the European Medicines Agency (EMA) in September 2022. It is approved for adult patients with chronic insomnia characterized by difficulties with sleep onset and/or sleep maintenance [1][2].
How does Quviviq work?
Daridorexant, the active ingredient in Quviviq, is a dual orexin receptor antagonist. It blocks the binding of orexin-A and orexin-B to both OX1R and OX2R receptors in the brain. Orexins are neurotransmitters that promote wakefulness. By inhibiting their action, daridorexant reduces the drive for wakefulness, thereby facilitating sleep onset and maintenance [1][3].
What is the recommended dosage and administration for Quviviq?
The recommended starting dose for Quviviq is 25 mg taken orally once daily, approximately 30 minutes before bedtime. Based on clinical response, the dose may be increased to 50 mg. Doses of 25 mg and 50 mg are considered effective and generally well-tolerated. It is advised not to take Quviviq if an individual cannot get a full night's sleep before needing to wake up [2][4].
Are there any contraindications or precautions for Quviviq use?
Quviviq is contraindicated in patients with narcolepsy, as orexin deficiency is associated with this condition. Caution is advised in patients with hepatic impairment, as Quvivix is metabolized by the liver. The medication may also cause sleep paralysis, hypnagogic or hypnopompic hallucinations, and catatonia. Patients should be monitored for these potential side effects [2].
What are the common side effects of Quviviq?
Commonly reported side effects of Quviviq include somnolence (drowsiness), headache, and fatigue. In clinical trials, somnolence was the most frequent adverse event. Patients are advised to avoid driving or operating heavy machinery until they know how Quviviq affects them, due to the risk of drowsiness [2][4].
When does the patent for Quviviq expire in Europe?
Information regarding the specific patent expiry dates for Quviviq in Europe can be found on DrugPatentWatch.com. Patent protection for pharmaceuticals is complex and can involve multiple patents covering the active ingredient, formulation, and methods of use. These dates determine when generic versions of the drug can enter the market [5].
Who manufactures Quviviq in Europe?
Quviviq is developed and marketed by Idorsia Pharmaceuticals. It is available in several European countries following its EMA approval [2][6].