Quviviq

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. 5). The maximum daily dose is 50 mg. 3 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. 2). 4). 2). 5). The consumption of grapefruit or grapefruit juice in the evening should be avoided. 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. 2).

Summary of safety profile The most frequently reported adverse reactions were headache and somnolence. 8 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 subjects was consistent with younger subjects. Tabulated list of adverse reactions Table 1 shows adverse reactions that occurred in Study 1 and Study 2 or in post-marketing experience. The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The safety of daridorexant was evaluated in three placebo-controlled Phase 3 clinical studies. A total of 1847 subjects (including approximately 40% elderly subjects [≥ 65 years old]) received daridorexant 50 mg (N = 308); 25 mg (N = 618); or 10 mg (N = 306), or placebo (N = 615).

A total of 576 subjects were treated with daridorexant for at least 6 months and 331 for at least 12 months.

Table 1:

Adverse reactions System organ class Adverse reaction Frequency Immune system disorders Hypersensitivity (including rash, urticaria) Uncommon Psychiatric disorders Hallucination Uncommon Abnormal dreams, nightmares Uncommon Somnambulism Uncommon Nervous system disorders Headache Common Somnolence Common Dizziness Common Sleep paralysis Uncommon Gastrointestinal disorders Nausea Common General disorders and administration site conditions Fatigue Common Description of selected adverse reactions Somnolence Somnolence was reported in 3% and 2% of subjects treated with daridorexant 25 mg and 50 mg, respectively, compared to 2% of subjects on placebo.

Elderly Because of the general risk of falls in the elderly, daridorexant should be used with caution in this population, although clinical studies did not show an increase in the incidence of falls on daridorexant compared to placebo.

QUVIVIQ should be administered with caution in patients older than 75 years since efficacy and safety data in this population are limited. 7). Caution should be exercised when prescribing QUVIVIQ concomitantly with CNS-depressant medicinal products due to potentially additive effects, and a dose adjustment of either QUVIVIQ or the concomitant CNS depressants should be considered.

5). 8). Symptoms similar to mild cataplexy have been reported with dual orexin receptor antagonists. Prescribers should explain the nature of these events to patients when prescribing QUVIVIQ. Should such events occur, patients need to be further evaluated and, depending on the nature and severity of the events, discontinuation of treatment should be considered.

Worsening of depression and suicidal ideation In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions have been reported. As with other hypnotics, QUVIVIQ should be administered with caution in patients exhibiting symptoms of depression.

Isolated cases of suicidal ideation have been reported in Phase 3 clinical studies, in subjects with pre- existing psychiatric conditions and/or stressful living conditions, across all treatment groups, including placebo. Suicidal tendencies may be present in patients with depression and protective measures may be required.

Patients with psychiatric co-morbidities QUVIVIQ should be administered with caution in patients with psychiatric co-morbidities since efficacy and safety data in this patient population are limited. Patients with compromised respiratory function Daridorexant did not increase the frequency of apnoea/hypopnoea events or cause oxygen desaturation in patients with mild to moderate (5 to < 30 events per hour of sleep) or severe (≥ 30 events per hour 5 of sleep) obstructive sleep apnoea (OSA).

1. • Narcolepsy. 5). 4