FDA Approves Bupropion Extended-Release Tablets for the Treatment of SAD

The US FDA recently approved bupropion extended-release tablets (Wellbutrin XL, GlaxoSmithKline), the first drug approved specifically for the treatment of seasonal affective disorder (SAD). Suggested dosing starts at 150 mg QD, titrated to 300 mg QD after 1 week of treatment if tolerated. Doses above 450 mg QD are not recommended and may produce serious adverse affects. Bupropion XL is approved for those 18 years and over.

Approval was based on 3 clinical trials with a total of 1,042 patients. A combined analysis of the trials shows that bupropion XL lowers the chance of developing SAD by 44%. The most common side effects include dry mouth, nausea, constipation, and flatulence in under 5% of patients.

Full prescribing information can be found at www.wellbutrinxl.com.