Serious neuropsychiatric symptoms (e.g., depression, suicidal ideation, suicide attempt, completed suicide) have been reported in patients receiving varenicline for smoking cessation. (See Neuropsychiatric Symptoms and Suicidality under Cautions.)
Such effects have occurred in patients with or without psychiatric illnesses. Safety and efficacy of varenicline not established in patients with serious psychiatric illness (e.g., schizophrenia, bipolar disorder, major depressive disorder); such patients may experience recurrence or worsening of symptoms during varenicline therapy.
Depressed mood may be a symptom of nicotine withdrawal; however, some symptoms occurred in varenicline-treated patients who continued to smoke.
Most symptoms occurred during varenicline therapy, but some were reported following discontinuance of drug.
Monitor all patients receiving varenicline for neuropsychiatric symptoms, including changes in behavior, hostility, agitation, depressed mood, and suicide-related events (including ideation, behavior, and attempted suicide).
Patient should discontinue varenicline and immediately contact clinician if agitation, hostility, depressed mood, or changes in thinking or behavior not typical for the patient occur, or if patient develops suicidal ideation or behavior.
Symptoms resolved upon drug discontinuance in many cases, but persisted in some. Provide ongoing patient monitoring and supportive care until symptoms resolve.
Weigh risks of varenicline therapy against benefits of its use for smoking cessation.
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