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The study’s purpose was to evaluate if bupropion, an antidepressant agent, can influence the pharmacokinetic profile of zolpidem, a sedative/hypnotic drug, and its main metabolite (zolpidem phenyl-4-carboxylic acid, Z4CA). The open-label, non-randomized, sequential clinical trial consisted of two periods: Period 1, when each volunteer received a single dose of zolpidem 5 mg and Period 2, when a combination of zolpidem 5 mg and bupropion 300 mg was administered, after a 7-day pre-treatment with bupropion. Pharmacokinetic analysis used for the non-compartmental approach and safety evaluations were conducted during the study. Bupropion pre-treatment decreased mean Cmax and AUC0-∞ for zolpidem and increased the same parameters for Z4CA. Most of zolpidem’s pharmacokinetic parameters displayed statistically significant differences between study periods. These results demonstrated that a pharmacokinetic interaction does occur between these drugs, possibly due to CYP3A4 induction, hypothesis which needs to be further investigated.

ASSESSMENT OF THE EFFECTS OF STEADY-STATE BUPROPION ON THE PHARMACOKINETIC PROFILE OF ZOLPIDEM IN HEALTHY VOLUNTEERS