Safety profile of QUVIVIQ™
There was no evidence of abuse or withdrawal symptoms indicative of physical dependence when QUVIVIQ™ treatment was discontinued in clinical studies.6 However, 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.6
The safety profile of QUVIVIQ™ has been demonstrated for 12 months of continuous treatment. Note that treatment duration should be as short as possible; appropriateness of continuation should be assessed within 3 months and periodically thereafter.6
Safety profile
The majority of adverse reactions were mild to moderate in intensity. The adverse reaction profile in elderly subjects was consistent with that in younger subjects.6
Clinical studies did not show an increase in the incidence of falls for QUVIVIQ™ compared with placebo.6
Adverse reactions in Study 1 and Study 26
| System organ class | Adverse reaction | Frequency |
|---|---|---|
| Psychiatric disorders | Hallucination | 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 |
Common: occurring in ≥ 1/100 to < 1/10 patients; uncommon: occurring in ≥ 1/1,000 to < 1/100 patients.
- Somnolence was reported in 3% and 2% of subjects treated with QUVIVIQ™ 25 mg and 50 mg, respectively, compared with 2% of subjects on placebo6
- Sleep paralysis was reported in 0.5% and 0.3% of subjects receiving QUVIVIQ™ 25 mg and 50 mg, respectively, compared with no reports for placebo6
- Hypnagogic and hypnopompic hallucinations were reported in 0.6% of subjects receiving QUVIVIQ™ 25 mg compared with no cases with QUVIVIQ™ 50 mg or placebo6
Special warnings and precautions for use6
Elderly patients
No dose adjustment is required in elderly patients (>65 years). Because of the general risk of falls in the elderly, QUVIVIQ™ should be used with caution in this population, although clinical studies did not show an increase in the incidence of falls on QUVIVIQ™ compared with placebo.
QUVIVIQ™ should be administered with caution in patients older than 75 years since efficacy and safety data in this population are limited.
No data are available in patients older than 85 years.
Sleep paralysis, hallucinations and cataplexy‑like symptoms
Sleep paralysis and hypnagogic/ hypnopompic hallucinations can occur with QUVIVIQ™ (daridorexant), mainly during the first weeks of treatment. 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.
Patients with psychiatric comorbidities
QUVIVIQ™ should be administered with caution in patients with psychiatric comorbidities since efficacy and safety data in this patient population are limited.
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 QUVIVIQ™ in subjects with insomnia. In an abuse liability study of QUVIVIQ™ (50, 100 and 150 mg) conducted in non‑insomniac recreational drug users (n=72), QUVIVIQ™ (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.
CNS-depressant effects
Because QUVIVIQ™ 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. 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™.
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 III 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 compromised respiratory function
QUVIVIQ™ 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 of sleep) obstructive sleep apnoea (OSA). Nor did it cause oxygen desaturation in patients with moderate COPD. QUVIVIQ™ has not been studied in patients with COPD (FEV1 <40% of predicted).
Caution should be exercised when prescribing QUVIVIQ™ to patients with severe COPD.
Patients with hepatic impairment
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CNS: central nervous system; COPD: chronic obstructive pulmonary disorder; FEV1: forced expiratory volume (in 1 second); OSA: obstructive sleep apnoea
QUVIVIQ™ is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.6
This information is intended for UK healthcare professionals.
Adverse events must be reported. Healthcare professionals are asked to report any suspected adverse reactions via www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to ds.safety.uk@idorsia.com
References
- Riemann D, Benz F et al. Insomnia disorder: state of the science and challenges for the future. J Sleep Res 2022;31(4):e13604
- Ellis J, Ferini‑Strambi L et al. Chronic insomnia disorder across europe: expert opinion on challenges and opportunities to improve care. Healthcare (Basel) 2023;11(5)
- Hudgens S, Phillips‑Beyer A et al. Development and validation of the insomnia daytime symptoms and impacts questionnaire (IDSIQ). Patient 2021;14(2):249‑268
- Mignot E, Mayleben D et al. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double‑blind, placebo‑controlled, phase 3 trials. Lancet Neurol 2022;21(2):125‑139
- Luyet P, Olivieri A, Braunstein G. Understanding daytime functioning in insomnia: responder and correlation analyses in patients treated with daridorexant. Sleep Sci Pract 2023;7(7)
- QUVIVIQ™ Idorsia Pharmaceuticals Ltd, Summary of Product Characteristics
- Mignot E, Mayleben D et al. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double‑blind, placebo‑controlled, phase 3 trials. Lancet Neurol 2022;21(2):125‑139 (suppl)
© NICE 2023 Daridorexant for treating long-term insomnia. Available from www.nice.org.uk/guidance/ta922. All rights reserved. Subject to Notice of rights.
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/ publication.
UK-DA-00655 | Date of preparation: September 2025
