a 28% increased risk of fatigue, a 56% increased risk of insomnia, a 63% increased risk of sleep disorders, and more than twice the risk of abnormal dreams. There was evidence of a 25% reduction in the risk of anxiety. When we used risk differences, for every 1000 patients there were an additional 10 cases of fatigue, 40 cases of insomnia, 20 cases of sleep disorders, and 60 cases of abnormal dreams in those prescribed varenicline compared with placebo. Similarly, there were 10 fewer episodes of anxiety per 1000 participants in the varenicline group compared with the placebo group (risk difference −0.01, 95% confidence interval −0.02 to −0.0003). There was no evidence of a variation in depression and suicidal ideation by age, sex, ethnicity, presence or absence of psychiatric illness, or type of study sponsor.
