The most common adverse events varied by treatment group but were consistent with previous research. In the placebo condition the most common adverse events were headaches, skin irritation in the patch condition, sleep disturbances/abnormal dreams in the bupropion condition, nausea in the lozenge condition, sleep disturbances/abnormal dreams in the bupropion + lozenge condition and both sleep disturbances/abnormal dreams and skin irritation in the patch + lozenge condition (see Table 4 for frequencies). Participants in the combination conditions (patch + lozenge and bupropion + lozenge) reported more adverse events than those in either the monotherapy or placebo groups. There were multiple serious adverse events (SAEs) during the 6 month period following the TQD, but very few were attributed to study medication. (See Table 5 for a description of the specific SAEs.) Four people (0.27%) withdrew from the study due to events related to medication: one in the bupropion condition because it interacted with other antidepressants and the participant’s physician requested that the participant withdraw, one in the bupropion condition because of heartburn, one from a “negative experience” on the placebo medication and one in the bupropion + lozenge condition due to hospitalization for seizures.
