b"Now Covered on TRICAREInsomnia impacts both night & day, 1Insomnia needs a wake up callQUVIVIQ 50 mg helped adults with insomnia sleep better and feel less tired the next day2,3Improvements 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 now covered on the Uniform Formulary 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 parameters(Tier 2 PA/ST) for TRICARE patientsof 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 November 2022.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. PK, pharmacokinetics.INDICATION patients exhibiting symptoms of depression. Monitoring suicide riskNeed to Evaluate for Comorbid Diagnoses Geriatric UseQUVIVIQ (daridorexant) is indicated for the treatment of adult patientsand protective measures may be required. Treatment 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/orSleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, andthe patient. Re-evaluate for comorbid conditions if insomnia fails to remitparticularly the elderly, are at higher risk of falls. No dosage adjustment sleep maintenance.Cataplexy-Like Symptoms after 7 to 10 days of treatment. Worsening insomnia or new cognitive oris required in patients over the age of 65 years. Sleep paralysis, an inability to move or speak for up to severalbehavioral abnormalities may be the result of an underlying psychiatric orHepatic ImpairmentIMPORTANT SAFETY INFORMATION minutes during sleep-wake transitions, and hypnagogic/hypnopompicmedical disorder and can emerge during treatment with sleep-promotingQUVIVIQ is not recommended in patients with severe hepatic Contraindications hallucinations, including vivid and disturbing perceptions, can occurdrugs such as QUVIVIQ. impairment. Reduce the dose in patients with moderate hepatic QUVIVIQ is contraindicated in patients with narcolepsy.with QUVIVIQ. Explain these events to patients. Most Common Adverse Reactions impairment.Warnings and Precautions Symptoms similar to mild cataplexy have been reported with orexinThe most common adverse reactions (reported in5% of patientsDrug Abuse and Dependencereceptor antagonists and can include periods of leg weakness lastingtreated with QUVIVIQ and at an incidenceplacebo) were headache andQUVIVIQ is a Schedule IV controlled substance.Central Nervous System (CNS) Depressant Effects and Daytimefrom seconds to a few minutes, can occur at night or during the day,somnolence or fatigue.Impairment and may not be associated with a triggering event (e.g., laughter orDrug Interactions Because individuals with a history of abuse or addiction to alcohol QUVIVIQ can impair daytime wakefulness. CNS depressant effects maysurprise). or other drugs may be at increased risk for abuse and addiction to persist in some patients up to several days after discontinuing QUVIVIQ.Complex Sleep Behaviors CYP3A4 Inhibitors: The recommended dose of QUVIVIQ is 25 mgQUVIVIQ, follow such patients carefully.Advise patients about the potential for next-day somnolence. when used with a moderate CYP3A4 inhibitor. Concomitant use of Driving ability was impaired in some subjects taking QUVIVIQ 50 mg.Complex sleep behaviors, including sleep-walking, sleep-driving, andQUVIVIQ with a strong inhibitor of CYP3A4 is not recommended. Please see the Brief Summary on the next page.Risk of daytime impairment is increased if QUVIVIQ is taken with lessengaging in activities while not fully awake (e.g., preparing and eatingCYP3A4 Inducers: Concomitant use of QUVIVIQ with a strong or than a full night of sleep or at a higher than recommended dose. Iffood, making phone calls, having sex), have been reported to occurmoderate inducer of CYP3A4 is not recommended. References: 1. Diagnostic and Statistical Manual of Mental Disorders. 5th with the use of hypnotics, including orexin receptor antagonists, suched. American Psychiatric Association; 2013. 2. QUVIVIQ (daridorexant) taken in these circumstances, caution patients against driving or otheras QUVIVIQ. These events can occur in hypnotic-nave as well as inUse in Speci c Populations [prescribing information]. Radnor, PA: Idorsia Pharmaceuticals US activities requiring complete mental alertness. hypnotic-experienced persons. Patients usually do not remember thesePregnancy and Lactation Inc; 2022. 3. Mignot E, Mayleben D, Fietze I, et al. Safety and efcacy Use with other CNS depressants increases the risk of CNS depression,events. Complex sleep behaviors may occur following therst or anyThere are no available data on QUVIVIQ use in pregnant women toof daridorexant in patients with insomnia disorder: results from two which can cause daytime impairment. Dosage adjustment of QUVIVIQsubsequent use of hypnotics, with or without the concomitant use ofevaluate for drug-associated risks of major birth defects, miscarriage,multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. and CNS depressants may be necessary when administered together.alcohol and other CNS depressants. Discontinue QUVIVIQ immediatelyor other adverse maternal or fetal outcomes. There will be a pregnancyLancet Neurol. 2022;21:125-139.Use with other insomnia drugs is not recommended. Advise patientsif a patient experiences a complex sleep behavior. exposure registry that monitors pregnancy outcomes in women exposed not to consume alcohol in combination with QUVIVIQ. Patients with Compromised Respiratory Function to QUVIVIQ during pregnancy. Pregnant women exposed to QUVIVIQ and Worsening of Depression/Suicidal Ideation The effects of QUVIVIQ on respiratory function should be consideredhealthcare providers are encouraged to call Idorsia Pharmaceuticals at Patients with psychiatric disorders including insomnia are at increasedfor patients with compromised respiratory function. QUVIVIQ has not1-833-400-9611. risk of suicide. In primarily depressed patients treated with hypnotics,been studied in patients with moderate obstructive sleep apnea (OSA)There are no data on the presence of daridorexant in human milk, theQUVIVIQ360worsening of depression, suicidal thoughts and actions (includingrequiring CPAP, severe OSA or severe chronic obstructive pulmonaryeffects on the breastfed infant, or the effects on milk production. Monitoris here to help put patients' completed suicides) have been reported. Administer with caution indisease (COPD). infants exposed to QUVIVIQ through breastmilk for excessive sedation. coverage challenges to rest. VISIT QUVIVIQhcp.com2022 Idorsia Pharmaceuticals, Ltd. US-DA-00618 11/22"