Neuropsychiatric Symptoms

Serious neuropsychiatric symptoms have occurred in patients being treated with Varenicline.

Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking; however, some of these symptoms have occurred in patients who continued to smoke.

All patients being treated with SmokeLESS should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.

These symptoms, as well as worsening of pre-existing psychiatric illness, have been reported in patients attempting to quit smoking while taking varenicline in the post-marketing experience.

Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of varenicline and the safety and efficacy of varenicline in such patients has not been established. Advise patients and caregivers that the patient should stop taking SmokeLESS and contact a health care provider immediately if agitation, depressed mood, or changes in behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior.