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Module 3: Clinical data for QUVIVIQ™ (daridorexant)
Introduction
Chronic insomnia, also known as long-term insomnia or chronic insomnia disorder, has a significant impact on people’s health and wellbeing. It goes beyond difficulties with falling and staying asleep, impacting daytime functioning, mood, cognition and overall quality of life.1-3 There remains an unmet need in the management of insomnia for therapies that can improve the quality of night-time sleep without negatively affecting daytime functioning.4
QUVIVIQ™, a dual orexin receptor antagonist, was licensed in 2022 for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.5 The recommendations in NICE technology appraisal guidance TA922: daridorexant for treating long-term insomnia (18 October 2023) were based on clinical trial evidence showing that QUVIVIQ™ improves symptoms of insomnia compared with placebo for 12 months.6 These studies assessed both night-time and daytime insomnia‑related symptoms.1
Learning objectives
By completing this module, you will increase your awareness and understanding of:
- the data underpinning the NICE recommendation for QUVIVIQ™
- how QUVIVIQ™ can address both daytime and night‑time symptoms of chronic insomnia1
- the benefit/ risk profile of QUVIVIQ™
Multiple-choice questions to test your current knowledge
These questions will help you assess your current knowledge of this topic before you begin to work on the module. Your answers will be marked but will not count towards your final score. You will be asked the same questions again at the end of the module and will be able to download a learning certificate for your records upon completion.
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Management of the symptoms of chronic insomnia with QUVIVIQ™
IDSIQ: Insomnia Daytime Symptoms and Impacts Questionnaire; LPS: latency to persistent sleep; NICE: National Institute for Health and Care Excellence; TST: total sleep time; WASO: wake time after sleep onset
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.5
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
- 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
- Riemann D, Nissen C et al. The neurobiology, investigation, and treatment of chronic insomnia. Lancet Neurol 2015;14(5):547‑558
- Riemann D, Spiegelhalder K et al. The hyperarousal model of insomnia: a review of the concept and its evidence. Sleep Med Rev 2010;14(1):19‑31
- Campbell R, Chabot I et al. Understanding the unmet needs in insomnia treatment: a systematic literature review of real‑world evidence. Int J Neurosci 2023;133(8):864‑878
- QUVIVIQ™ Idorsia Pharmaceuticals Ltd, Summary of Product Characteristics
- National Institute for Health and Care Excellence (NICE). Technology appraisal guidance 922. Daridorexant for treating long‑term insomnia, 18 October 2023. Available at: nice.org.uk. Accessed August 2025
© 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