Demonstrated safety studied over 12 months

Patients taking QUVIVIQ every night over 12 months reported1,2:

No evidene image No evidene image mobile

No evidence of physical
dependence or
withdrawal symptoms
upon discontinuation *

No rebound insomnia image No rebound insomnia image mobile

No rebound insomnia
after discontinuation

Adverse reaction image Adverse reaction mobile image

Adverse reaction rates
comparable between
doses and to placebo

  • QUVIVIQ contains daridorexant, which is a Schedule IV controlled substance3

* Clinical studies of chronic administration suggest QUVIVIQ does not produce physical dependence. In controlled efficacy and safety studies, withdrawal effects were assessed by the Tyrer Benzodiazepine Withdrawal Symptom Questionnaire following discontinuation of 10 mg, 25 mg, and 50 mg QUVIVIQ, and by adverse event reporting during a single-blind placebo run-out period.3

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Safety profile of QUVIVIQ 50 mg comparable to placebo and QUVIVIQ 25 mg

Reported adverse reactions (Study 1)3,4*

Reported adverse reactions (Study 1)3,4*


System organ class
QUVIVIQ
25 mg
(n=310)
QUVIVIQ
50 mg
(n=308)

Placebo
(n=309)
Nervous system disorders#colspan##colspan##colspan#
Headache6% 7%5%
Somnolence
or fatigue
6%5%4%
  Somnolence4%2%2%
  Fatigue2%3%1%
Dizziness2%3%2%
Gastrointestinal disorders#colspan##colspan##colspan#
Nausea0%3%2%

Adverse reactions reported in ≥2% of patients treated with QUVIVIQ and greater than with placebo.

The following terms were combined: Headache includes: headache, tension headache, migraine, migraine with aura, head discomfort. Dizziness includes: dizziness, vertigo, labyrinthitis. Nausea includes: nausea, vomiting, procedural nausea.

Somnolence or fatigue includes: somnolence, sedation, fatigue, hypersomnia, and lethargy. Rates of sedation were <1% with both QUVIVIQ doses and 1% for placebo. Rates of hypersomnia and lethargy were <1% for all groups.

Safety was evaluated in adults taking QUVIVIQ every night
over 12 months, including patients ≥65 years
3

No dose adjustment is required for patients ≥65 years; however, QUVIVIQ can increase somnolence and drowsiness so patients, particularly the elderly, are at higher risk of falls.

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