Quviviq Special Precautions

CNS-depressant effects: Because daridorexant acts by reducing wakefulness, patients should be cautioned about engaging in potentially hazardous activities, driving, or operating heavy machinery unless they feel fully alert, especially in the first few days of treatment (see Effects on ability to drive and use machines as follows).
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.
Patients should be cautioned about drinking alcohol during treatment with QUVIVIQ (see Interactions).
Sleep paralysis, hallucinations and cataplexy-like symptoms: Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions, can occur with daridorexant, mainly during the first weeks of treatment (see Adverse Reactions).
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 or moderate obstructive sleep apnoea (OSA), nor did it cause oxygen desaturation in patients with moderate chronic obstructive pulmonary disease (COPD). Daridorexant has not been studied in patients with severe OSA (apnoea-hypopnoea index ≥ 30 events per hour) or with severe COPD (FEV₁ < 40% of predicted).
Caution should be exercised when prescribing QUVIVIQ to patients with severe OSA and severe COPD.
Potential for abuse and dependence: There was no evidence of abuse or withdrawal symptoms indicative of physical dependence upon treatment discontinuation in clinical studies with daridorexant in subjects with insomnia.
In an abuse liability study of daridorexant (50, 100 and 150 mg) conducted in non-insomniac recreational drug users (n = 72), daridorexant (100 and 150 mg) produced similar "drug liking" ratings as zolpidem (30 mg). Because individuals with a history of abuse or addiction to alcohol or other substances may be at increased risk for abuse of QUVIVIQ, these patients should be followed carefully.
Hepatic impairment: Use is not recommended in patients with severe hepatic impairment (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
Excipients: Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: Hypnotics have a major influence on the ability to drive and use machines.
A randomised, double-blind, placebo- and active-controlled, cross-over study evaluated the effects of nighttime administration of daridorexant on next-morning driving performance, using a driving simulator, 9 hours after dosing in non-insomniac, healthy subjects aged from 50 to 79 years. Testing was conducted after 1 night (initial dosing) and after 4 consecutive nights of treatment with daridorexant 50 mg. Zopiclone 7.5 mg was used as an active comparator.
In the morning after first-dose administration, daridorexant impaired simulated driving performance as measured by the Standard Deviation of the Lateral Position (SDLP). No effect on driving performance was detected after 4 consecutive nights of administration. Zopiclone significantly impaired simulated driving performance at both time points.
Patients should be cautioned about engaging in potentially hazardous activities, driving, or operating heavy machinery unless they feel fully alert, especially in the first few days of treatment (see previously mentioned). In order to minimise this risk, a period of approximately 9 hours is recommended between taking QUVIVIQ and driving or using machines.
Use in the 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.