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Home » News
Publish Date May 3, 2022
QUVIVIQ NOW AVAILABLE FOR ADULTS WITH INSOMNIA
Brian Park, PharmD
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Quviviq is classified as a Schedule IV controlled substance. Credit: Idorsia.
Quviviq (daridorexant) is now available for the treatment of adults with
insomnia characterized by difficulties with sleep onset and/or sleep
maintenance.
Quviviq contains daridorexant, an orexin receptor antagonist. Approval was based
on data from a comprehensive development program that included two phase 3
studies (ClinicalTrials.gov Identifier: NCT03545191 [Study 1] and NCT03575104
[Study 2]). The double-blind studies compared the efficacy and safety of
daridorexant to placebo in 1854 patients 18 years of age and older with insomnia
for 3 months.
Findings from Study 1 and Study 2 showed that daridorexant demonstrated
statistically significant and clinically meaningful improvements in sleep onset,
sleep maintenance, and patient reported total sleep time. Patients treated with
daridorexant also had a significant reduction in daytime sleepiness, as assessed
by a validated sleep diary questionnaire.
The most common adverse reactions reported were headache and somnolence or
fatigue. Daridorexant was not associated with next morning residual effects,
rebound insomnia, or withdrawal symptoms upon discontinuation.
As with other hypnotics, there is a risk of CNS depressant effects, worsening of
depression or suicidal ideation, sleep paralysis, hypnagogic/hypnopompic
hallucinations, cataplexy-like symptoms, and complex sleep behaviors. Quviviq is
contraindicated in patients with narcolepsy. Additionally, the treatment has not
been studied in patients with moderate obstructive sleep apnea (OSA) requiring
CPAP, severe OSA, or severe COPD; the effects of Quviviq on respiratory function
should be considered if prescribed to patients with compromised respiratory
function.
Quviviq tablets are available in 2 dosage strengths: 25mg and 50mg.
Coadministration with strong CYP3A4 inhibitors or with strong or moderate CYP3A4
inducers should be avoided. Patients taking moderate CYP3A4 inhibitors or those
with moderate hepatic impairment should not take more than 25mg once per night.
Quviviq is not recommended for patients with severe hepatic impairment.
Treatment should be administered within 30 minutes of going to bed, with at
least 7 hours remaining prior to planned awakening, as the risk of daytime
impairment is increased if the drug is taken with less than a full night of
sleep remaining. Time to sleep onset may be delayed if Quviviq is take with or
soon after a meal.
References
1. Idorsia’s new treatment Quviviq (daridorexant) is now available in the US
for adults living with insomnia. News release. Idorsia Pharmaceuticals Ltd.
Accessed May 2, 2022.
https://www.globenewswire.com/news-release/2022/05/02/2433104/0/en/Idorsia-s-new-treatment-QUVIVIQ-daridorexant-is-now-available-in-the-US-for-adults-living-with-insomnia.html
2. Quviviq. Package insert. Idorsia Pharmaceuticals Ltd; 2021. Accessed January
10, 2022. https://www.idorsia.us/documents/us/label/Quviviq_PI.pdf
TOPICS:
General Psychiatry Insomnia Sleep Disorders
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