Considerations for the use of QUVIVIQ™ in older adults

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Considerations for the use of QUVIVIQ™ in older adults

Duration of use18

Clinical data for QUVIVIQ™ are available for up to 12 months of continuous treatment. However, treatment duration should be as short as possible and appropriateness of continuation should be assessed within 3 months of starting and periodically thereafter. QUVIVIQ™ can be stopped without tapering off and if necessary can be re‑started at the same dose.

Dependence/ tolerance18
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.
Individuals with a history of abuse or addiction to alcohol or other substances may be at increased risk for abuse of QUVIVIQ™ and should be followed carefully.
Renal impairment18
QUVIVIQ™ can be administered to patients with any degree of renal function impairment without the need for dose adjustment.
Older patients18
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.
The adverse reaction profile in elderly subjects is consistent with younger subjects.
Sleep apnoea18
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 of sleep) OSA.

Steve’s clinician considers QUVIVIQ™ to be an appropriate treatment for him, and after consultation, prescribes a once‑daily dose of 50 mg, to be taken in the 30 minutes before going to bed.18* A follow-up appointment is arranged for 8 weeks’ time.

*Based on clinical judgement, some patients may be treated with 25 mg QUVIVIQ™ once per night. The recommended dose for patients with moderate hepatic impairment or who are taking concomitant moderate CYP3A4 inhibitors is 25 mg once per night.18 Consult the Summary of Product Characteristics for complete prescribing information.

Before prescribing QUVIVIQ™18

Steve’s clinician explained:

  • Sleep paralysis, hallucinations, somnambulism (sleepwalking), abnormal dreams/nightmares and hypersensitivity may occur during the first weeks of treatment (these are listed as uncommon adverse reactions in the SPC: frequency 0.1%‑1%). Symptoms similar to mild cataplexy have also been reported with dual orexin receptor antagonists
    • If these events occur, patients should be evaluated and discontinuation of treatment considered
  • Somnolence, headache, dizziness, nausea and fatigue are all listed as common adverse reactions in the SPC (frequency 1%‑10%)
  • Alcohol should be avoided when using QUVIVIQ™

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ACE: angiotensin-converting enzyme; CBTi: cognitive behavioural therapy for insomnia; CKD: chronic kidney disease; CPAP: continuous positive airway pressure; CYP3A4: cytochrome P450 3A4; ISI: Insomnia Severity Index; OSA: obstructive sleep apnoea; OTC: over-the-counter; SGLT2i: sodium glucose cotransporter-2 inhibitor; TIA: transient ischaemic attack

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.18

This information is intended for UK healthcare professionals.

▼This medicine is subject to additional monitoring.

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

  1. Sleep Foundation. Aging and sleep, 19 September 2023. Available at: sleepfoundation.org. Accessed August 2025
  2. National Institutes of Health (NIH): National Institute on Aging. A good night’s sleep. Available at: nia.nih.gov. Accessed August 2025
  3. Patel D, Steinberg J, Patel P. Insomnia in the elderly: a review. J Clin Sleep Med 2018;14(6):1017-1024
  4. Cohen Z L, Eigenberger P M et al. Insomnia and other sleep disorders in older adults. Psychiatr Clin North Am 2022;45(4):717-734
  5. Duffy J F, Scheuermaier K, Loughlin K R. Age-related sleep disruption and reduction in the circadian rhythm of urine output: contribution to nocturia? Curr Aging Sci 2016;9(1):34-43
  6. Riemann D, Espie C A et al. The European Insomnia Guideline: an update on the diagnosis and treatment of insomnia 2023. J Sleep Res 2023;32(6):e14035
  7. Wilson S, Anderson K et al. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update. J Psychopharmacol 2019;33(8):923-947
  8. National Institute for Health and Care Excellence (NICE). Clinical knowledge summary. Insomnia. Scenario: managing long-term insomnia (more than 3 months duration), May 2025. Available at: cks.nice.org.uk. Accessed August 2025
  9. National Institute for Health and Care Excellence (NICE). Clinical knowledge summary. Stroke and TIA. Scenario: secondary prevention following stroke and TIA, October 2023. Available at: cks.nice.org.uk. Accessed August 2025
  10. Morin C M, Belleville G et al. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep 2011;34(5):601-608
  11. Solikhah F K, Nursalam N, Ulfiana E. The effect of sleep hygiene on the sleep quality in elderly. Proceedings of the 8th International Nursing Conference on Education, Practice and Research Development in Nursing (INC 2017) 2017;doi: 10.2991/inc-17.2017.26
  12. National Institute for Health and Care Excellence (NICE). Clinical knowledge summary. Obstructive sleep apnoea syndrome. Scenario: management of sleep apnoea, May 2025. Available at: cks.nice.org.uk. Accessed August 2025
  13. Prolonged-release melatonin Summary of Product Characteristics
  14. National Institute for Health and Care Excellence (NICE). Clinical knowledge summary. Insomnia. Scenario: managing short-term insomnia (less than 3 months duration), May 2025. Available at: cks.nice.org.uk. Accessed August 2025
  15. Zolpidem Summary of Product Characteristics
  16. Zopiclone Summary of Product Characteristics
  17. National Institute for Health and Care Excellence (NICE). Clinical knowledge summary. Insomnia. Prescribing information: Z-drugs, May 2025. Available at: cks.nice.org.uk. Accessed August 2025
  18. QUVIVIQ™ Idorsia Pharmaceuticals Ltd, Summary of Product Characteristics

© 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.

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UK-DA-00657 | Date of preparation: September 2025

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