 There have been rare post-marketing reports of serious neuropsychiatric symptoms with varenicline, including depressed mood, agitation, hostility, changes in behavior, suicidal ideation and suicide, as well as worsening of pre-existing psychiatric illness previously diagnosed or not. It is not known whether these events are occurring at a rate and severity which is different from the background rate for smoking cessation in the general population, or in the psychiatric population treated or untreated, or different from the rates for other drugs in the class of smoking cessation. 