Safe, well-tolerated treatments for bipolar I depression are limited.
Over 6 months, open-label adjunctive armodafinil was generally safe and well tolerated.
Mean measures for emergence of mania, suicidality, anxiety, or insomnia did not worsen.
Results suggest a positive risk profile of adjunctive armodafinil in bipolar I depression.
Adjunctive armodafinil efficacy remains to be established, and it does not have an FDA indication for bipolar I depression.