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Smoking cessation - Management
How long should I prescribe varenicline for?

  • The recommended course of treatment is 12 weeks.
  • For people who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks' treatment with varenicline at 1 mg twice daily may be considered to help maintain abstinence.
Basis for recommendation
  • One study assessed the benefit of an additional 12 weeks of varenicline therapy on the maintenance of abstinence. Participants in an open-label study who were abstinent after 12 weeks of varenicline 1 mg twice a day were randomized to continue varenicline or to receive placebo for an additional 12 weeks. The primary study end point was the continuous abstinence rate from week 13 to week 24 in the double-blind treatment phase. A key secondary end point was the continuous abstinence rate for week 13 to week 52.
    • At week 24, the odds of maintaining abstinence following an additional 12 weeks of treatment with varenicline were 2.5 times those for placebo (odds ratio 2.47, 95% CI 1.95 to 3.15).
    • At week 52, the odds of maintaining abstinence following an additional 12 weeks of treatment with varenicline were 1.4 times those for placebo (odds ratio 1.35, 95% CI 1.07 to 1.70).
  • No data are available on the efficacy of an additional 12 weeks course of treatment for people who do not succeed in stopping smoking during initial therapy or who relapse after treatment.

[ABPI Medicines Compendium, 2008]

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