Background Varenicline is known to have greater efficacy than other pharmacotherapy for treating nicotine dependence and has gained popularity since its introduction in 2006. This study examines if adding varenicline to existing pharmacotherapies increased the population cessation rate.

Methods Data are from two cross-sectional US Current Population Surveys—Tobacco Use Supplements (2003 and 2010–2011). Smokers and recent quitters 18 or older (N=34 869 in 2003, N=27 751 in 2010–2011) were asked if they had used varenicline, bupropion or nicotine replacement therapies (NRT) in their most recent quit attempt. The annual cessation rate, as well as the per cent of smokers who had quit for ≥3 months, was compared between surveys.

Results Varenicline use increased from 0% in 2003 to 10.9% in 2010–2011, while use of bupropion decreased from 9.1% to 3.5%, and NRT from 24.5% to 22.4%. Use of any pharmacotherapy increased by 2.4 percentage points. Varenicline users stayed on cessation aids longer and were less likely to relapse than users of other pharmacotherapies in the first 3 months of a quit attempt, after which the difference was no longer significant. The change in annual cessation rate was negligible, from 4.5% in 2003 to 4.7% in 2010–2011 (p=0.36).

Conclusions Addition of varenicline to the list of approved cessation aids has mainly led to displacement of other therapies. As a result, there was no meaningful change in population cessation rate despite a remarkable increase in varenicline use. The population impact of a new therapy is a function of more than efficacy or reach of the therapy.