- INTRODUCTION: Worldwide, 10 to 35% of pregnant women smoke. It is clear that smoking cessation has positive impacts for both the mother and child, yet many women are still unable to quit due to the addictive properties of nicotine. There are limited data surrounding their safety and efficacy in pregnancy. AREAS COVERED: This review highlights evidence from clinical studies and animal experiments regarding the effects of smoking cessation therapeutics on pregnancy, neonatal and long-term postnatal outcomes. EXPERT OPINION: There are insufficient data at this time to recommend the use of varenicline and/or bupropion for smoking cessation during pregnancy. In addition, the efficacy and safety of nicotine replacement therapy use for smoking cessation in pregnant women has not been clearly demonstrated. Until further studies are completed, there will continue to be considerable uncertainty regarding the use of these drugs in pregnancy despite the well-documented benefits of smoking cessation.