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QUVIVIQ is a brand name for Daridorexant, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: QUVIVIQ (daridorexant) is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. 1.1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of QUVIVIQ in pediatric patients have not been established; therefore, Health Canada…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Food Effect: QUVIVIQ can be taken with or without food, however, sleep onset may be delayed if taken with or soon after a high-fat and high-calorie meal. 5 Drug-Food Interactions.
Co-administration with CYP3A4 inhibitors:
The recommended dose of QUVIVIQ is 25 mg when used with moderate CYP3A4 inhibitors. Concomitant use of QUVIVIQ with strong inhibitors of CYP3A4 is contraindicated. 4 Drug-Drug Interactions, Effect of other compounds on the PK of daridorexant.
Co-administration with CNS-depressants:
In the case of co-administration of QUVIVIQ with CNS- depressant drugs, dose adjustments of QUVIVIQ and/or the other drug(s) may be required, based on clinical evaluation, due to potentially additive effects. 2 Drug Interactions Overview, CNS-active agents.
2 Recommended Dose and Dosage Adjustment The recommended dose of QUVIVIQ for adults is one tablet of 50 mg once per night, taken orally in the evening within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening.
QUVIVIQ® (daridorexant) Page 5 of 29 Some patients may be treated with 25 mg once per night. See 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic and 9 DRUG INTERACTIONS.
Pediatrics (< 18 years of age):
The safety and efficacy of QUVIVIQ in pediatric patients have not been established. Therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥ 65 years of age):
No dose adjustment is required in patients over the age of 65 years.
Patients with hepatic impairment:
No dose adjustment is required in patients with mild hepatic impairment. The recommended dose of QUVIVIQ is 25 mg in patients with moderate hepatic impairment. QUVIVIQ has not been studied and is not recommended in patients with severe hepatic impairment.
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Impairment.
Patients with renal impairment:
1 Adverse Reaction Overview The most frequently reported adverse reaction during the double-blind treatment period in Phase 3 clinical trials with QUVIVIQ (reported in at least 2% of patients and with a ≥ 1% difference vs placebo) was headache.
The majority of adverse reactions were mild to moderate in intensity. No evidence of a dose-relationship for the frequency or severity of adverse reactions was observed. The adverse reaction profile in elderly patients was consistent with younger patients.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The safety of QUVIVIQ was evaluated in three placebo-controlled Phase 3 clinical studies (two 3-month confirmatory studies of identical design [Study 1 and Study 2], and a 9-month extension study [Study 3]).
Study 1 included the 50 and 25 mg doses of QUVIVIQ, while Study 2 included 25 and 10 mg QUVIVIQ. A total of 1847 patients (including approximately 39% elderly patients [≥ 65 years old]), received QUVIVIQ 50 mg (N = 308); 25 mg (N = 618); or 10 mg (N = 306) or placebo (N = 615).
A total of 576 patients were treated with QUVIVIQ for at least 6 months and 331 for at least 12 months. Table 2 shows adverse reactions that occurred in at least 2% of patients treated with QUVIVIQ and more frequently (≥ 1%) than in patients who received placebo in Study 1 and Study 2.
Table 2 – Adverse reactions reported with a frequency of ≥ 2% in QUVIVIQ-treated patients and greater (≥ 1%) than in placebo-treated patients in 3-month efficacy trials (Study 1 and Study 2) System organ class QUVIVIQ 25 mg* N = 618 (%) QUVIVIQ 50 mg* N = 308 (%) Placebo* N = 615 (%) Nervous system disorders Headache 5 6 4 Somnolence 3 2 2 Dizziness 2 2 1 General disorders and administration site conditions Fatigue 3 2 1 Gastrointestinal disorders Nausea 1 2 1 * 50 mg incidence rates are from Study 1, 25 mg rates from pooled data.
2 Breast-feeding 11/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSAGE..............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 10 8 ADVERSE REACTIONS ................................................................................................
12 9 DRUG INTERACTIONS ................................................................................................ 15 10 CLINICAL PHARMACOLOGY .......................................................................................
16 11 STORAGE, STABILITY, AND DISPOSAL ........................................................................ 17 PART II: SCIENTIFIC INFORMATION .......................................................................................
17 13 PHARMACEUTICAL INFORMATION ............................................................................ 17 14 CLINICAL TRIALS ........................................................................................................
QUVIVIQ is contraindicated in: • Patients who are hypersensitive to daridorexant or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients with narcolepsy. • Patients taking a concomitant strong CYP3A4 inhibitor.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No dose adjustment is required in patients with renal impairment (including severe). 3 Pharmacokinetics, Special Populations and Conditions, Renal Impairment. 5 Missed Dose QUVIVIQ should be taken within 30 minutes before going to bed.
If a patient forgets to take QUVIVIQ, they should not take it later during the night, otherwise they may feel drowsy in the morning.
Placebo rates were the same in Study 1 and in the pooled data. QUVIVIQ® (daridorexant) Page 12 of 29 Unclassified / Non classifié The adverse reactions reported during long-term treatment up to 1 year were consistent with those observed during the first 3 months of treatment.
3% of patients receiving daridorexant 25 mg and 50 mg, respectively, compared to no reports for placebo. 6% of patients receiving daridorexant 25 mg compared to no cases with daridorexant 50 mg or placebo. See 7 WARNINGS AND PRECAUTIONS, General, Sleep paralysis, hallucinations, and cataplexy-like symptoms.
5 Post-Market Adverse Reactions Immune system disorders: Hypersensitivity (such as angioedema, rash, urticaria) Psychiatric disorders: Abnormal dreams or nightmares, complex sleep behaviours (see 7 WARNINGS AND PRECAUTIONS, General, Complex Sleep Behaviours)
19 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 23 PATIENT MEDICATION INFORMATION ..................................................................................
24 QUVIVIQ® (daridorexant) Page 4 of 29 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS QUVIVIQ (daridorexant) is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of QUVIVIQ in pediatric patients have not been established; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (≥ 65 years of age): No dose adjustment is required in patients over the age of 65 years.
2 CONTRAINDICATIONS QUVIVIQ is contraindicated in: • Patients who are hypersensitive to daridorexant or to any ingredient in the formulation, including any […]