Quviviq Dosage/Direction for Use

Posology: The recommended dose for adults is one tablet of 50 mg once per night, taken orally in the evening within 30 minutes before going to bed. Based on clinical judgement, some patients may be treated with 25 mg once per night (see Precautions and Interactions).
The maximum daily dose is 50 mg.
The treatment duration should be as short as possible. The appropriateness of continued treatment should be assessed within 3 months and periodically thereafter. Clinical data are available for up to 12 months of continuous treatment.
Treatment can be stopped without down-titration.
Missed dose: If a patient forgets to take QUVIVIQ at bedtime, that dose should not be taken during the night.
Hepatic impairment: In patients with mild hepatic impairment, no dose adjustment is required. In patients with moderate hepatic impairment, the recommended dose is one tablet of 25 mg once per night (see Pharmacology: Pharmacokinetics under Actions). In patients with severe hepatic impairment, daridorexant has not been studied and is not recommended (see Precautions).
Renal impairment: In patients with renal impairment (including severe), no dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Co-administration with moderate CYP3A4 inhibitors: The recommended dose when used with moderate CYP3A4 inhibitors is one tablet of 25 mg once per night (see Interactions).
The consumption of grapefruit or grapefruit juice in the evening should be avoided.
Co-administration with central nervous system (CNS) depressants: In the case of co-administration with CNS-depressant medicinal products, dose adjustments of QUVIVIQ and/or the other medicinal products may be required, based on clinical evaluation, due to potentially additive effects (see Precautions and Interactions).
Elderly: No dose adjustment is required in elderly patients (> 65 years). Limited data are available in patients older than 75 years. No data are available in patients older than 85 years.
Paediatric population: The safety and efficacy of daridorexant in paediatric patients have not yet been established. No data are available.
Method of administration: For oral use.
QUVIVIQ can be taken with or without food. However, taking QUVIVIQ soon after a large meal may reduce the effect on sleep onset (see Pharmacology: Pharmacokinetics under Actions).