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some patients experienced worsening of their psychiatric illnesses Some neuropsychiatric adverse events, including unusual and sometimes aggressive behavior directed to oneself or others, may have been worsened by concomitant use of alcohol Advise patients and caregivers that the patient should stop taking varenicline and contact a healthcare provider immediately if agitation, depressed mood, or changes in behavior or thinking that are not typical are observed, or if the patient develops suicidal ideation or suicidal behavior Alcohol interaction Patients should reduce amount alcohol they consume when initiating therapy until they know whether it increases intoxicating effects Postmarketing reports of patients experiencing increased intoxicating effects of alcohol while taking varenicline