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The efficacy of QUVIVIQ was evaluated at Months 1 and 3 when taken every night in the pivotal trials and showed that QUVIVIQ continued to improve sleep over time. Additionally, when QUVIVIQ was taken every night, patients saw improvements in sTST at Week 1 that continued to build over 3 to 4 weeks.1

Beyond the two 3-month pivotal studies, QUVIVIQ was also evaluated in a 40-week extension safety study, which included exploratory efficacy endpoints, for a total of 12 months of treatment duration. When taken nightly over 12 months in clinical trials, no evidence of withdrawal symptoms were reported upon discontinuation.2,3

See the efficacy data for once-nightly QUVIVIQ.

No, QUVIVIQ was evaluated in clinical trials for its impact on the range of insomnia symptoms, which included both efficacy and safety outcomes related to daytime sleepiness. Rates of fatigue and next-day somnolence were reported as part of the QUVIVIQ safety profile.1

With QUVIVIQ, “daytime sleepiness” refers to the unique daytime efficacy outcome measured by the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). In this patient-reported secondary efficacy endpoint, patients were asked to complete a daily self-assessment about how energetic, mentally and physically tired, and sleepy they felt during treatment. The change from baseline in these assessment scores (the IDSIQ sleepiness domain) was evaluated at Months 1 and 3.2,5

See the daytime outcomes data.

IDSIQ is the Insomnia Daytime Symptoms and Impacts Questionnaire, which is the first patient-reported outcome tool developed and validated according to FDA guidelines that can evaluate daytime symptoms in patients with insomnia.5

IDSIQ includes 14 items of daytime symptoms across 3 domains: sleepiness, mood, and alert/cognition.

Change from baseline in the IDSIQ sleepiness domain score at Month 1 and Month 3 was a key secondary endpoint in the QUVIVIQ clinical trials.2 See the IDSIQ results.

Patients should avoid alcohol consumption with QUVIVIQ. Concomitant use of alcohol or other CNS depressants with QUVIVIQ may lead to additive impairment of psychomotor performance and risk of CNS depression. Patients should be cautioned about the potential for next-morning driving impairment because there is individual variation in sensitivity to QUVIVIQ.1

Concomitant use with strong CYP3A4 inhibitors (eg, itraconazole, clarithroymycin) should also be avoided. With moderate CYP3A4 inhibitors (eg, diltiazem, fluconazole, grapefruit), the maximum recommended dose of QUVIVIQ is 25 mg. Concomitant use of QUVIVIQ with a strong or moderate inducer of CYP3A4 is not recommended.1,6

In clinical trials and animal studies evaluating physical dependence, stopping administration of QUVIVIQ did not produce withdrawal signs or symptoms upon drug discontinuation. This suggests that QUVIVIQ does not produce physical dependence.1

QUVIVIQ is contraindicated in patients with narcolepsy and in patients with a history of hypersensitivity to QUVIVIQ.1

Clinical studies have demonstrated no evidence of physical dependence, withdrawal symptoms upon discontinuation, or rebound insomnia. QUVIVIQ contains daridorexant, which is a Schedule IV controlled substance.1-3

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.1

Avoid concomitant use with strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin) and strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). With moderate CYP3A4 inhibitors (eg, diltiazem, fluconazole), the maximum recommended dose of QUVIVIQ is 25 mg.1,6

Co-administration of a single 50 mg dose of QUVIVIQ with alcohol at a blood level of 0.6 g/L led to additive effects on impairment of psychomotor performance (postural stability and alertness). QUVIVIQ did not affect alcohol concentrations and alcohol did not affect QUVIVIQ concentrations.1

Adverse reactions with QUVIVIQ were comparable between doses and to placebo. They include headache (≤7% with QUVIVIQ vs 5% with placebo), next-day somnolence or fatigue (≤6% with QUVIVIQ vs 4% for placebo), and dizziness and nausea (≤3% with QUVIVIQ vs 2% for placebo, respectively).1

QUVIVIQ can impair daytime wakefulness even when used as prescribed. Effects may persist in some patients for several days after discontinuing QUVIVIQ.

See additional safety profile information and full Important Safety Information for QUVIVIQ.

QUVIVIQ is indicated for the treatment of insomnia in adult patients ≥18 years of age, and clinical trials included adults ≥65 years old. When QUVIVIQ was taken every night, patients, including those ≥65 years, saw improvements at Week 1 that continued to build over 3 to 4 weeks.1*

Most common adverse reactions for all patients included headache, next-day somnolence or fatigue, and dizziness/nausea. In adults ≥65 years (50 mg, n=119; 25 mg, n=121; placebo, n=122)1,7:

• Rates of next-day somnolence were 5% for 25 mg, 0.8% for 50 mg, and 0.8% for placebo
• Rates of fatigue were 3.3% for 25 mg, 2.5% for 50 mg, and 0.8% for placebo

Additionally, fall rates were evaluated in the pivotal trials. Rates of falls with QUVIVIQ were <1% in Study 1 vs 3% with placebo, and rates in Study 2 were balanced across treatment groups (1%). QUVIVIQ can increase somnolence and drowsiness so patients, particularly the elderly, are at higher risk of falls.1,2

See the full safety profile.

*Based on subjective total sleep time data.

The recommended dose of QUVIVIQ is 25 mg or 50 mg. The greatest improvement in sleep was seen with once-nightly QUVIVIQ 50 mg compared with placebo, and QUVIVIQ 50 mg reduced daytime sleepiness.1,2

When taken every night, QUVIVIQ 50 mg improved sleep over time and patients felt less tired the next day.* Patients, including those ≥65 years, saw improvements with once-nightly QUVIVIQ at Week 1 that continued to build over 3 to 4 weeks.1,2†

Patients treated with QUVIVIQ 50 mg also saw statistically significant reductions in patient-reported daytime sleepiness in Study 1, as assessed by IDSIQ (secondary endpoint). The reductions in daytime sleepiness with QUVIVIQ 25 mg were not statistically significant in either Study 1 or Study 2.2

The adverse reactions with QUVIVIQ were comparable between doses and to placebo, including headache (≤7% with QUVIVIQ vs 5% with placebo), next-day somnolence or fatigue (≤6% with QUVIVIQ vs 4% for placebo), and dizziness and nausea (≤3% with QUVIVIQ vs 2% with placebo, respectively). Rates of falls with QUVIVIQ were less than 1% in Study 1 vs 3% with placebo, and rates in Study 2 were balanced across treatment groups (1%).1,2

When taken nightly over 12 months of treatment, patients reported no evidence of withdrawal symptoms upon discontinuation.2,3

Explore the nighttime and daytime efficacy data for QUVIVIQ 50 mg.

*Improvements measured at Months 1 and 3.

†Based on subjective total sleep time data.

The recommended dose of QUVIVIQ is 25 mg or 50 mg, and QUVIVIQ was designed to be taken once every night. For patients with moderate hepatic impairment or taking a moderate CYP3A4 inhibitor, 25 mg is recommended. Avoid use with strong CYP3A4 inhibitors or strong CYP3A4 inducers and in patients with severe hepatic impairment. QUVIVIQ is contraindicated in patients with narcolepsy and in patients with a history of hypersensitivity to QUVIVIQ.1

QUVIVIQ was designed to be taken once every night. In clinical trials, greatest efficacy was seen with QUVIVIQ 50 mg compared with placebo, although both doses showed statistically significant improvements compared with placebo.

See full dosing and administration information.

Advise patients that QUVIVIQ was designed to be taken once every night within 30 minutes before bed and at least 7 hours before they plan to wake up. Time to sleep onset may be delayed if taken with or soon after a meal.1

When transitioning your patient from another insomnia medication to QUVIVIQ, be sure to consider any discontinuation symptoms of the prior medication such as withdrawal or risk for rebound insomnia. Tell your patients not to discontinue QUVIVIQ or increase their dose on their own, and to inform you if they believe QUVIVIQ isn’t providing the efficacy they need.

See full dosing and administration information.

QUVIVIQ works differently than other sleep medications that sedate the brain. QUVIVIQ is thought to block overactive wake signals, one of the underlying causes of insomnia. QUVIVIQ reaches peak plasma concentration levels within 1-2 hours and has an 8-hour half-life.1,2

The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.1

QUVIVIQ may be different than other insomnia treatments your patients have taken in the past, so it’s important to talk to them about what to expect from treatment.

Tell your patients that QUVIVIQ works differently, is taken differently, and is experienced differently.

Download this guide for more details on what your patients need to know.

QUVIVIQ360 is a comprehensive program designed to help patients with insurance coverage support, seamlessly-applied savings, and ongoing education. QUVIVIQ360 is powered by KnippeRx^® Custom Pharmacy Solutions to provide your patients convenient access to QUVIVIQ.

Learn more.

When you prescribe through QUVIVIQ360 powered by KnippeRx^® Custom Pharmacy Solutions, QSavings offers are seamlessly applied for eligible patients. Patients can receive their first 30-day supply of nightly QUVIVIQ for $0.* After the first 30-day supply, patients can receive subsequent refills for as little as $25.^† If you prescribe through another pharmacy, you can provide your patients with a QSavings Copay Card, which they can bring with them when they pick up their first prescription. If your patient cannot afford QUVIVIQ, QUVIVIQ360 may be able to help.

*Eligibility restrictions apply.

†For eligible commercially insured patients. Terms and conditions apply.Please read the full terms and conditions. If your patients cannot afford QUVIVIQ, call 833-248-0021 to see how QUVIVIQ360 may be able to help.

Simply e-prescribe your patient’s QUVIVIQ prescription to KnippeRx:

Select in your EHR system: Knipperx, NCPDP #1568560, NPI #1285159152, 1250 Patrol Road, Suite #100, Charlestown, IN, 47111.

If you cannot e-prescribe, please call 833-248-0021