QUVIVIQ Film-coated tablet Ref.[49885] Active ingredients: Daridorexant

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 sections 4.4 and 4.5).

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 section 5.2). In patients with severe hepatic impairment, daridorexant has not been studied and is not recommended (see section 4.4).

Renal impairment

In patients with renal impairment (including severe), no dose adjustment is required (see section 5.2).

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 section 4.5).

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 sections 4.4 and 4.5).

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 section 5.2).

In clinical pharmacology studies, healthy subjects were administered single doses of up to 200 mg daridorexant (4 times the recommended dose). At supra-therapeutic doses, adverse reactions of somnolence, muscular weakness, disturbance in attention, fatigue, headache, and constipation were observed.

There is no specific antidote to an overdose of daridorexant. In the event of an overdose, general symptomatic and supportive medical care should be provided and patients should be carefully monitored. Dialysis is unlikely to be effective as daridorexant is highly protein-bound.

30 months.

This medicinal product does not require any special storage conditions.

Polyvinyl chloride (PVC) coated with polyvinylidene chloride (PVdC) and laminated with PVC film blister sealed with an aluminium foil blister, packed in a carton box.

Pack size of 10 or 30 film-coated tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.