From the FDA Drug Label
QUVIVIQ contains daridorexant, an orexin receptor antagonist, present as daridorexant hydrochloride salt. The chemical name of daridorexant hydrochloride is (S)-(2-(5-chloro-4-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone hydrochloride.
- Daridorexant is an orexin receptor antagonist.
- It is used in the treatment of insomnia.
- The mechanism of action is through antagonism of orexin receptors, which play a role in wakefulness.
- Daridorexant binds to and inhibits the orexin receptors OX1R and OX2R 1
From the Research
Daridorexant is a dual orexin receptor antagonist approved for the treatment of insomnia in adults, with a recommended dose of 25-50 mg taken orally once daily, within 30 minutes before bedtime, as supported by the most recent study 2.
Key Points
- Daridorexant works by blocking orexin receptors in the brain, which helps regulate the sleep-wake cycle, as described in 3.
- The medication has been shown to be effective in improving sleep parameters, including wake time after sleep onset, latency to persistent sleep, and total sleep time, as demonstrated in 4 and 5.
- Common side effects include headache, drowsiness, fatigue, and dizziness, as reported in 4 and 6.
- Patients should take daridorexant only when they can get a full night's sleep (at least 7 hours) and should avoid alcohol while using it, as recommended in the studies.
- It's not recommended for people with severe liver impairment or narcolepsy, and as a controlled substance (Schedule IV), it has potential for dependence, so it should be used for the shortest duration necessary to treat insomnia symptoms, as noted in 3 and 6.
Dosage and Administration
- The recommended dose is 25-50 mg taken orally once daily, within 30 minutes before bedtime, as supported by 2.
- Patients should start with the lower 25 mg dose, which can be increased to 50 mg if needed and tolerated, as recommended in 2 and 5.
Safety and Efficacy
- Daridorexant has been shown to be well tolerated and effective in improving sleep quality, with a favorable safety profile, as demonstrated in 4, 5, and 6.
- The medication has been approved for use in adult patients with insomnia, and its efficacy and safety have been established in multiple randomized controlled trials, as reported in 4 and 5.