CBTi and traditional pharmacological treatments

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CBTi and traditional pharmacological treatments

CBTi

CBTi is an evidence-based alternative to drug therapy and is the recommended first‑line treatment for chronic insomnia, given face‑to‑face or digitally.1,7,8 Treatment involves behavioural techniques including sleep restriction, stimulus control, cognitive therapy and relaxation training.1,7,8 Some patients may report mild daytime sedation in the early stages of sleep restriction and stimulus control.1 The effects of CBTi may last after treatment has ended and there is evidence to suggest benefit to mood, wellbeing, and social and occupational functioning.1

If CBTi is not effective or not available, or if the patient is unsuitable or non‑compliant, drug treatment can be considered.8

Traditional pharmacological treatments

Benzodiazepines (BZ)/ benzodiazepine receptor agonists (BZRAs)

BZs and BZRAs are effective for the treatment of short-term insomnia (<4 weeks).8 BZs are gamma‑aminobutyric acid (GABA) receptor agonists which enhance GABA‑mediated inhibition of the CNS arousal systems, promoting sleep.1 These include nitrazepam, lormetazepam and temazepam.8 These drugs are only recommended for short‑term treatment as patients can develop tolerance, which gradually reduces their effectiveness, and drug dependence can also occur.1,7,8 BZs are also associated with so‑called ‘hangover effects’ such as daytime drowsiness due to their long half‑lives.1 BZs/BZRAs with shorter half‑lives maybe associated with fewer of these effects.8

Note that NICE does not recommend the use of any BZ for the treatment of acute or chronic insomnia.3,4

Z-drugs

Z-drugs, also GABA receptor agonists, were developed to mitigate the negative effects of benzodiazepines used in the treatment of chronic insomnia.1 Their shorter half-lives versus benzodiazepines can make these drugs less effective at maintaining sleep during the night.1 Zolpidem and zopiclone are only recommended for short-term treatment as potential remains for tolerance and dependence.1,7

NICE does not recommend long-term management of chronic insomnia with hypnotic drugs. Treatment should be a short course (3-7 days) for severe symptoms or an acute exacerbation.1,7

Sedating antidepressants

Although tricyclic antidepressants have long been used for insomnia, this off-label use has little evidence of efficacy.1,8 Trazodone has been used for insomnia however there are few robust studies supporting its use.1 Mirtazepine has been shown to reduce insomnia in depression, particularly at the start of treatment.1 These drugs may be useful for the treatment of patients with concomitant chronic insomnia and depression/ mood disorders,1 but long-term treatment of chronic insomnia with antidepressants is not recommended due to side effects/ risks.8

Melatonin

Prolonged-release melatonin is indicated for people >55 years with primary insomnia.9 Initially it should be given for 3 weeks and, if the patient responds, treatment can be continued for 10 weeks.7 There should be an awareness of the risk of falls/ fractures when being prescribed in older adults.7 Some melatonin formulations are licensed for the treatment of insomnia associated with behavioural disorders in children and adolescents,10 although immediate-release melatonin is not recommended for insomnia, unless jet lag/ circadian factors are involved.1,8

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Prescribing QUVIVIQ™: what you need to know

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BAP: British Association for Psychopharmacology; BZ: benzodiazepines; BZRAs: benzodiazepine receptor agonists; CBTi: cognitive behavioral therapy for insomnia; CNS: central nervous system; EIN: European Insomnia Network; ESRS: European Sleep Research Society; GABA: gamma-aminobutyric acid; NICE: National Institute for Health and Care Excellence; OTC: over‑the‑counter

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.

▼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. 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
  2. O’Regan D, Garcia-Borreguero D et al. Mapping the insomnia patient journey in Europe and Canada. Front Public Health 2023;11:1233201
  3. 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
  4. 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
  5. QUVIVIQ™ Idorsia Pharmaceuticals Ltd, Summary of Product Characteristics
  6. 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
  7. National Institute for Health and Care Excellence (NICE). Clinical knowledge summary. Insomnia, May 2025. Available at: cks.nice.org.uk. Accessed August 2025
  8. 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
  9. Prolonged-release melatonin Summary of Product Characteristics
  10. British National Formulary (BNF). Melatonin. Available from bnf.nice.org.uk, Accessed August 2025
  11. Roch C, Bergamini G et al. Nonclinical pharmacology of daridorexant: a new dual orexin receptor antagonist for the treatment of insomnia. Psychopharmacology (Berl) 2021;238(10):2693-2708
  12. Robbins R, Quan S F et al. A nationally representative survey assessing restorative sleep in US adults. Front Sleep 2022;1:935228
  13. 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;21:125-139
  14. Kunz D, Dauvilliers Y et al. Long-term safety and tolerability of daridorexant in patients with insomnia disorder. CNS Drugs 2023;37:93-106
  15. Chaput J P, Dutil C, Sampasa-Kanyinga H. Sleeping hours: what is the ideal number and how does age impact this? Nat Sci Sleep 2018;10:421-430
  16. Di Marco T, Djonlagic I et al. Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder – a pooled post hoc analysis of two randomized phase 3 clinical studies. Sleep 2024:zsae098
  17. Watson N F, Benca R M et al. Alliance for sleep clinical practice guideline on switching or deprescribing hypnotic medications for insomnia. J Clin Med 2023;12(7):2493

© 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-00653 | Date of preparation: September 2025

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