QUVIVIQ

Daridorexant plasma exposure is dose proportional from 25 mg to 50 mg. The daridorexant pharmacokinetic profile is similar following multiple-dose and single-dose administration with no accumulation.

AbsorptionDaridorexant reaches peak plasma concentrations within 1–2 hours (T max ). Daridorexant has an absolute bioavailability of 62%. Effect of food In healthy subjects, a high-fat and high-calorie meal delayed the T max by 1.3 hours and decreased the C max by 16%, but did not affect the total ...

14.1 Controlled Clinical Studies The efficacy of QUVIVIQ was evaluated in two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies,

Study 1(NCT03545191) and

Study 2(NCT03575104). A total of 1854 patients with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5 ® ) insomnia were randomized to receive QUVIVIQ or placebo once daily, in the evening, for 3 months. Study 1 randomized 930 subjects to QUVIVIQ 50 mg (N = 310), 25 mg (N = 310) or placebo (N = 310). Study 2 randomized 924 subjects to QUVIVIQ 25 mg (N = 309), 10 mg (N = 307), or placebo...

The following are discussed in detail in other sections of the labeling: CNS-Depressant Effects and Daytime Impairment [see Warnings and Precautions (5.1) ] Worsening of Depression/Suicidal Ideation [see Warnings and Precautions (5.2) ] Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms [see Warnings and Precautions (5.3) ] Complex Sleep Behaviors [see Warnings and Precautions (5.4) ] Patients with Compromised Respiratory Function [see Warnings and Precautions (5...

QUVIVIQ is contraindicated: in patients with narcolepsy. in patients with a history of hypersensitivity to daridorexant or any components of QUVIVIQ. Angioedema with pharyngeal involvement has been reported [see Adverse Reactions (6.2) ] . Narcolepsy. ( 4 ) Known hypersensitivity to daridorexant or other components of QUVIVIQ. ( 4 )

CNS-Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. Risk increases when used with other central nervous system (CNS) depressants. For patients taking QUVIVIQ, caution against next-day driving and other activities requiring complete mental alertness. ( 5.1 ) Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. ( 5.2 ) Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy...

7 DRUG INTERACTIONS Strong CYP3A4 inhibitors: Avoid concomitant use. ( 2.2 , 7.1 ) Moderate CYP3A4 inhibitors: Maximum recommended dose is 25 mg. ( 2.2 , 7.1 ) Moderate or Strong CYP3A4 inducers: Avoid concomitant use. ( 7.1 ) 7.1 Effects of Other Drugs on QUVIVIQ Table 2 describes clinically significant drug interactions where the concomitant use of other drugs affects QUVIVIQ.

Table 2Effects of...