What is Wellbutrin (bupropion) indicated for?

Wellbutrin (Bupropion) Indications

Wellbutrin is FDA-approved for two specific indications: treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). 1

FDA-Approved Indications

Major Depressive Disorder (MDD)

• Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder as defined by the Diagnostic and Statistical Manual (DSM). 1
• The efficacy was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. 1
• The sustained-release formulation demonstrated efficacy in maintenance treatment of MDD in a long-term trial (up to 44 weeks) in patients who had responded to bupropion during an 8-week acute treatment study. 1

Seasonal Affective Disorder (SAD)

• Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder. 1
• Efficacy was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern. 1
• Treatment should be initiated in the autumn prior to onset of depressive symptoms, continued through the winter season, and tapered/discontinued in early spring. 1

Off-Label Uses Supported by Guidelines

Smoking Cessation

• The NCCN guidelines recognize bupropion as an effective smoking cessation agent, with a relative risk of 1.62 (95% CI, 1.49–1.76) for achieving abstinence compared to placebo. 2
• The standard dosing for smoking cessation is 150 mg twice daily (300 mg total) of the SR formulation, with treatment beginning 1-2 weeks before the target quit date. 3
• The EAGLES trial demonstrated that patients receiving bupropion achieved superior abstinence rates compared with placebo (OR, 2.07; 95% CI, 1.75–2.45). 2
• Bupropion may be particularly beneficial as a smoking cessation agent for persons with comorbid depression. 2, 3

Obesity/Weight Management (as Naltrexone-Bupropion ER)

• The AGA guidelines discuss the use of naltrexone-bupropion ER combination for pharmacological treatment of obesity in adults. 2
• This combination formulation is distinct from bupropion monotherapy and has separate FDA approval for weight management. 2
• Limited data show that combining sustained-release bupropion with naltrexone at the same doses used for obesity can reduce nicotine use and mitigate associated weight gain. 2

Clinical Advantages Across Indications

• Bupropion has significantly lower rates of sexual dysfunction compared to SSRIs, making it advantageous for patients concerned about this side effect. 3, 4
• It is associated with minimal weight gain or even weight loss, unlike many other antidepressants. 3
• Bupropion may be particularly beneficial for depressive subtypes characterized by decreased energy, pleasure, and interest due to its dopaminergic and noradrenergic effects. 5
• The medication has demonstrated efficacy in augmenting partial responses to SSRI antidepressants when used in combination therapy. 3, 4

Critical Safety Considerations

• Bupropion carries an FDA black box warning for increased risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. 1
• The medication reduces the seizure threshold with a 0.1% seizure risk at therapeutic doses for smoking cessation. 2
• Bupropion is contraindicated in patients with seizure disorders, eating disorders (bulimia/anorexia), current or recent MAOI use (within 14 days), uncontrolled hypertension, and during abrupt discontinuation of alcohol, benzodiazepines, or antiepileptic drugs. 2, 6, 1