Idorsia Pharmaceuticals, US Inc. has announced that the US Food and Drug Administration (FDA) has approved QUVIVIQ™ (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance1. The FDA approval of QUVIVIQ is based on an extensive clinical program that included 1,854 adults with insomnia at over 160 clinical trial sites across 18 countries. Insomnia, a serious medical condition, is the most common sleep disorder in the US.
QUVIVIQ is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain.
During the Phase 3 clinical program, QUVIVIQ demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance and patient-reported total sleep time. Consistent with the US prescribing information, the 50 mg dose of QUVIVIQ, which was evaluated in one of the two pivotal studies, demonstrated a significant reduction in patient-reported daytime sleepiness, using a validated instrument. The most common adverse reactions (in at least 5% of patients and greater than placebo) were headache (placebo: 5%, 25 mg: 6%, 50 mg: 7%,) and somnolence or fatigue (placebo: 4%, 25 mg: 6%, 50 mg: 5%).
The FDA has recommended that QUVIVIQ be classified as a controlled substance and it is anticipated to be available to patients in May 2022, following scheduling by the US Drug Enforcement Administration.
References
- QUVIVIQ Prescribing Information. Idorsia Pharmaceuticals US Inc. Jan/2022
Source: Idorsia Pharmaceuticals
I’ve struggled for 25 years and have been prescribed ambien which made a huge difference. I weened my self off after a couple years. 4 years ago I developed urethral stenosis which let to insomnia and anxiety due to nocturea. Eventually I was diagnosed with Interstitial Cystitis. I’ve done well for about a year. Once again another period of high stress, anxiety & stress has begun. I have sought treatment with my PCP, Gyrouerologist & most recently my cardiologist for chest pain a visit to the ER revealed no apparent diagnosible problem after 2 ekg’s, a chest x-ray, Covid & Flu tests. I see my cardiologist Monday for a Stress Test. The chest pains continue after a month as well as the aniexty and insomnia. How does a person get treated when doctors are afraid to prescribe even patients in genuine need of treatment for fear of an FDA “colonoscopy”? My ability to function and my quality of life & health a dimishing daily. How do I get help?