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Last reviewed: 20 Apr 2025
Last updated: 14 Mar 2025
14 Mar 2025

NICE recommends cytisinicline for smoking cessation, expanding treatment options for clinicians in the UK

​The National Institute for Health and Care Excellence (NICE) has updated its guidelines on smoking cessation, now recommending cytisinicline (also known as cytisine) as a pharmacological treatment option for adults aged 18-65 years who want to quit smoking. This addition places cytisinicline alongside other well-established interventions such as varenicline, nicotine replacement therapy (NRT), and bupropion.

A plant-derived alkaloid, cytisinicline acts as a partial agonist at the alpha-4 beta-2 nicotinic acetylcholine receptor, and has been used for decades in Eastern Europe. A growing body of evidence suggests that cytisinicline outperforms placebo and NRT and offers comparable effectiveness to varenicline in aiding smoking cessation. However, the NICE update committee acknowledged that evidence remains limited for certain population subgroups, especially those affected by health inequalities.

While the drug may increase the risk of nausea and insomnia compared to placebo or NRT, these adverse effects were generally mild. In contrast, varenicline was associated with a higher incidence of nausea. The committee noted that symptoms such as nausea and headaches may also be related to nicotine withdrawal, complicating the interpretation of adverse effect profiles.

NICE advises setting a quit date within the first 5 days of treatment. It stresses that cytisinicline, as with all types of pharmacotherapy for smoking cessation, should be prescribed within a comprehensive approach that includes behavioural support. It is not recommended for use in pregnant or breastfeeding women, nor for individuals under 18 or over 65 years.

This update offers primary care practitioners an additional, evidence-based tool to aid in smoking cessation, and provides a new option for patients seeking effective smoking cessation strategies. Healthcare professionals are encouraged to discuss the available options with patients to determine the most suitable treatment based on individual needs and preferences.

See Management: emerging

Original source of update

Summary

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Definition

History and exam

Key diagnostic factors

  • number of cigarettes per day
  • time to first cigarette (TTFC)
  • use of alternative tobacco and nicotine delivery products
  • history of substance use disorder (SUD)
  • pregnancy or breastfeeding

Other diagnostic factors

  • history of depression
  • history of schizophrenia
  • seizure disorder
  • hypertension
  • unstable cardiac disease
  • ventricular arrhythmia
  • asthma
  • chronic obstructive pulmonary disease (COPD)
  • temporomandibular joint or dental disorder

Risk factors

  • age <24 years
  • low socioeconomic status
  • history of mental illness or substance use disorder
  • history of HIV/AIDS
  • use of alternative tobacco and nicotine delivery products
  • genetics

Diagnostic investigations

1st investigations to order

  • self-report of smoking status
  • Fagerström Test For Nicotine Dependence (FTND)
  • Heaviness of Smoking Index (HSI)

Investigations to consider

  • carbon monoxide (CO) monitoring
  • cotinine level

Treatment algorithm

Contributors

Authors

Franck F. Rahaghi, MD, MHS, FCCP

Chairman

Pulmonary Department

Director

Pulmonary Education and Rehabilitation

Cleveland Clinic

Weston

FL

Disclosures

FFR is a consultant and speaker for Bayer, United Therapeutics, Janssen-PH, Merck, Boehringer Ingleheim, Takeda, and Talecris. He is involved in industry-sponsored research with Bayer, Janssen-PH, Gossamer Bio, and Bellerophon.

Samuel Gurevich, MD, FCCP

Pulmonary Department

Director

Respiratory Therapy

Cleveland Clinic

Weston

FL

Disclosures

SG declares that he has no competing interests.

Acknowledgements

Dr Franck F. Rahaghi and Dr Samuel Gurevich would like to gratefully acknowledge Dr Felix Hernandez, Dr Jose Gonzalez, and Dr Theodore W. Marcy, previous contributors to this topic.

Disclosures

FH, JG, and TWM declare that they have no competing interests.

Peer reviewers

Jaymin Morjaria, MBBS, FRCP, MD

Consultant Respiratory Physician

Guy’s and St Thomas NHS Foundation Trust

Harefield Hospital

Middlesex

Honorary Senior Lecturer

Brunel University

London

UK

Disclosures

JM has received honoraria for speaking and financial support to attend meetings/advisory boards from Wyeth, Chiesi, Pfizer, MSD, Boehringer Ingelheim, Teva, GSK/Allen & Hanburys, Napp, Almirall, AstraZeneca, Trudell, Cook Medical, Medela AG, Medtronics, and Novartis. He has been an expert witness in a court case relating to the impact of smoking on illness severity, ITU admissions, and mortality from Covid-19 in South Africa in 2020.

Arran Woodhouse, MSc

Senior Tobacco Programme Manager

North Central London Integrated Care Board

London

UK

Disclosures

AW has been reimbursed by Johnson & Johnson Ltd Nicorette UK Consulting for chairing the Smoking Cessation National Advisory Panel on 1 November 2022. He worked with NICE on the recent Tobacco Guideline (NG209) as a topic expert and as a specialist committee member for the treating dependence Quality Standards Advisory Committee (QS 207). He was appointed as an Expert Adviser for the NICE Centre for Guidelines in February 2023. Previous member of the British Thoracic Society's Tobacco Specialist Advisory Group.

References

Our in-house evidence and editorial teams collaborate with international expert contributors and peer reviewers to ensure that we provide access to the most clinically relevant information possible.

Key articles

United States Public Health Service Office of the Surgeon General; National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. Smoking cessation: a report of the Surgeon General. 2020 [internet publication].Full text  Abstract

Tobacco Use and Dependence Guideline Panel, US Department of Health and Human Services. Treating tobacco use and dependence: 2008 update. Rockville (MD): US Department of Health and Human Services; 2008.Full text

National Institute for Health and Care Excellence. Tobacco: preventing uptake, promoting quitting and treating dependence. Feb 2025 [internet publication].Full text

US Preventive Services Task Force. Interventions for tobacco smoking cessation in adults, including pregnant persons: US Preventive Services Task Force recommendation statement. JAMA. 2021 Jan 19;325(3):265-79.Full text  Abstract

Barua RS, Rigotti NA, Benowitz NL, et al. 2018 ACC expert consensus decision pathway on tobacco cessation treatment: a report of the American College of Cardiology Task Force on clinical expert consensus documents. J Am Coll Cardiol. 2018 Dec 5;72(25):3332-65.Full text  Abstract

Hartmann-Boyce J, Chepkin SC, Ye W, et al. Nicotine replacement therapy versus control for smoking cessation. Cochrane Database Syst Rev. 2018 May 31;(5):CD000146.Full text  Abstract

Reference articles

A full list of sources referenced in this topic is available here.

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