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Last reviewed: 12 Mar 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

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

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.

Pulmonary Department

Director

Respiratory Therapy

Cleveland Clinic

Weston

FL

Disclosures

SG declares that he has no competing interests.

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

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.

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.

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