Advice for healthcare professionals:
• Patients and their family or care-givers should be made aware of the possibility that trying to stop smoking might cause symptoms of depression
• Patients who are taking varenicline who develop suicidal thoughts or behaviour should stop their treatment and contact their doctor immediately
• Varenicline should be discontinued immediately if agitation, depressed mood, or changes in behaviour are observed that are of concern for the doctor , patient, family, or caregiver.
• Patients with serious psychiatric illness did not participate in the premarketing studies of varenicline, and the safety and efficacy of varenicline in such patients has not been established. Care should be taken when prescribing varenicline to patients who have a history of psychiatric illness.