b"Available on TRICARE and VA National FormularyInsomnia impacts both night & day 1Insomnia needs a wake up callQUVIVIQ 50 mg helped adults with insomnia sleep better and feel less tired the next day 2,3 Improvements inProven safety profilePK profile designed QUVIVIQ 50 mg provided statistically significant reduction in patient-reported daytime sleepiness in a singlesleep onset and sleepevaluated over 12 monthsfor consistent nightly adequate and well-controlled study (Study 1) as measured by IDSIQ Sleepiness Domain score (secondary endpoint)maintenance2,3 of treatment2 dosing2at Months 1 and 3. The 25 mg dose did not reach significance in either Study 1 or 2.Study Design: The safety and efficacy of QUVIVIQ was evaluated in two multicenter, randomized, double-blind, placebo-controlled, parallel-groupQUVIVIQ is available on the Uniform Formulary for studies over 3 months. Study 1 (N=930) included QUVIVIQ 25 mg (n=310), QUVIVIQ 5O mg (n=310), and placebo (n=310). Study 2 (N=617) included QUVIVIQ 25 mg (n=309) and placebo (n=308). Primary endpoints were change from baseline to Months 1 and 3 in the objective sleep parametersTRICARE patients and the VA National Formularyof LPS (sleep onset) and WASO (sleep maintenance). Secondary endpoints were change from baseline to Months 1 and 3 in the subjective sleep parameter of sTST (total sleep time) and daytime symptoms using the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) sleepinessSource: Managed Markets Insight & Technology, LLC database as of May 2023.domain score as measured using the eDiary. For informational purposes only. Idorsia makes no representation as to the accuracy or reliability of the information presented above, and this should not be considered a guarantee of coverage. LPS, latency to persistent sleep; PK, pharmacokinetics; sTST, subjective total sleep time; WASO, wake after sleep onset.INDICATION worsening of depression, suicidal thoughts and actions (includingNeed to Evaluate for Comorbid Diagnoses Geriatric UseQUVIVIQ (daridorexant) is indicated for the treatment of adult patientscompleted suicides) have been reported. Administer with caution inTreatment of insomnia should be initiated only after careful evaluation ofBecause QUVIVIQ can increase somnolence and drowsiness, patients, with insomnia characterized by dif culties with sleep onset and/orpatients exhibiting symptoms of depression. Monitoring suicide riskthe patient. Re-evaluate for comorbid conditions if insomnia fails to remitparticularly the elderly, are at higher risk of falls. No dosage adjustment sleep maintenance.and protective measures may be required. after 7 to 10 days of treatment. Worsening insomnia or new cognitive oris required in patients over the age of 65 years. Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy- behavioral abnormalities may be the result of an underlying psychiatric orHepatic ImpairmentIMPORTANT SAFETY INFORMATION Like Symptoms medical disorder and can emerge during treatment with sleep-promotingQUVIVIQ is not recommended in patients with severe hepatic Contraindications Sleep paralysis, an inability to move or speak for up to severaldrugs such as QUVIVIQ. impairment. Reduce the dose in patients with moderate hepatic QUVIVIQ is contraindicated:minutes during sleep-wake transitions, and hypnagogic/hypnopompicMost Common Adverse Reactions impairment.in patients with narcolepsy.hallucinations, including vivid and disturbing perceptions, can occurThe most common adverse reactions (reported in5% of patientsDrug Abuse and Dependencein patients with a history of hypersensitivity to daridorexant orwith QUVIVIQ. Explain these events to patients. treated with QUVIVIQ and at an incidenceplacebo) were headache andQUVIVIQ is a Schedule IV controlled substance.any components of QUVIVIQ.Symptoms similar to mild cataplexy have been reported with orexinsomnolence or fatigue. Because individuals with a history of abuse or addiction to alcohol receptor antagonists and can include periods of leg weakness lastingDrug InteractionsWarnings and Precautions from seconds to a few minutes, can occur at night or during the day,or other drugs may be at increased risk for abuse and addiction to Central Nervous System (CNS) Depressant Effects and Daytimeand may not be associated with a triggering event (e.g., laughter orCYP3A4 Inhibitors: The recommended dose of QUVIVIQ is 25 mgQUVIVIQ, follow such patients carefully.Impairment surprise). when used with a moderate CYP3A4 inhibitor. Concomitant use of QUVIVIQ can impair daytime wakefulness. CNS depressant effects mayComplex Sleep Behaviors QUVIVIQ with a strong inhibitor of CYP3A4 is not recommended. Please see the Brief Summary on the next page.persist in some patients up to several days after discontinuing QUVIVIQ.Complex sleep behaviors, including sleep-walking, sleep-driving, andCYP3A4 Inducers: Concomitant use of QUVIVIQ with a strong orReferences: 1. Diagnostic and Statistical Manual of Mental Disorders. 5th Advise patients about the potential for next-day somnolence. engaging in activities while not fully awake (e.g., preparing and eatingmoderate inducer of CYP3A4 is not recommended. ed. American Psychiatric Association; 2013. 2. QUVIVIQ (daridorexant) Driving ability was impaired in some subjects taking QUVIVIQ 50 mg.food, making phone calls, having sex), have been reported to occurUse in Speci c Populations [prescribing information]. Radnor, PA: Idorsia Pharmaceuticals US Risk of daytime impairment is increased if QUVIVIQ is taken with lesswith the use of hypnotics, including orexin receptor antagonists, suchPregnancy and Lactation Inc; 2023. 3. Mignot E, Mayleben D, Fietze I, et al. Safety and efcacy than a full night of sleep or at a higher than recommended dose. Ifas QUVIVIQ. These events can occur in hypnotic-nave as well as inThere are no available data on QUVIVIQ use in pregnant women toof daridorexant in patients with insomnia disorder: results from two taken in these circumstances, caution patients against driving or otherhypnotic-experienced persons. Patients usually do not remember theseevaluate for drug-associated risks of major birth defects, miscarriage,multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. activities requiring complete mental alertness. events. Complex sleep behaviors may occur following therst or anyor other adverse maternal or fetal outcomes. There will be a pregnancyLancet Neurol. 2022;21:125-139.Use with other CNS depressants increases the risk of CNS depression,subsequent use of hypnotics, with or without the concomitant use ofexposure registry that monitors pregnancy outcomes in women exposed which can cause daytime impairment. Dosage adjustment of QUVIVIQalcohol and other CNS depressants. Discontinue QUVIVIQ immediatelyto QUVIVIQ during pregnancy. Pregnant women exposed to QUVIVIQ and and CNS depressants may be necessary when administered together.if a patient experiences a complex sleep behavior. healthcare providers are encouraged to call Idorsia Pharmaceuticals at Use with other insomnia drugs is not recommended. Advise patientsPatients with Compromised Respiratory Function 1-833-400-9611.QUVIVIQ360not to consume alcohol in combination with QUVIVIQ. The effects of QUVIVIQ on respiratory function should be consideredThere are no data on the presence of daridorexant in human milk, the Worsening of Depression/Suicidal Ideation for patients with compromised respiratory function. QUVIVIQ has noteffects on the breastfed infant, or the effects on milk production. Monitoris here to help put patients' Patients with psychiatric disorders including insomnia are at increasedbeen studied in patients with moderate obstructive sleep apnea (OSA)infants exposed to QUVIVIQ through breastmilk for excessive sedation. coverage challenges to rest. VISIT QUVIVIQhcp.comrisk of suicide. In primarily depressed patients treated with hypnotics,requiring CPAP, severe OSA or severe chronic obstructive pulmonary disease (COPD).2023 Idorsia Pharmaceuticals, Ltd. US-DA-00953 11/23"