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BOXED WARNING Suicidality and Antidepressant Drugs Use in Treating Psychiatric Disorders Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of bupropion hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Bupropion hydrochloride tablets are not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders; PRECAUTIONS, Information for Patients; and PRECAUTIONS, Pediatric Use). Use in Smoking Cessation Treatment Bupropion hydrochloride tablets , WELLBUTRIN SR(bupropion hydrochloride sustained-release tablets), and WELLBUTRIN XL(bupropion hydrochloride extended-release tablets) are not approved for smoking cessation treatment, but bupropion under the name ZYBAN(bupropion hydrochloride sustained-release tablets) is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke. All patients being treated with bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of preexisting psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking ZYBAN(bupropion hydrochloride sustained-release tablets) in the postmarketing experience. When symptoms were reported, most were during treatment with ZYBAN(bupropion hydrochloride sustained-release tablets), but some were following discontinuation of treatment with ZYBAN(bupropion hydrochloride sustained-release tablets). Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of ZYBAN The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. ZYBAN(bupropion hydrochloride sustained-release tablets) has been demonstrated to increase the likelihood of abstinence from smoking for as long as 6 months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial (see WARNINGS, Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment and PRECAUTIONS, Information for Patients).