Absence of an interaction between ibuprofen and zaleplon

The potential interaction between zaleplon and ibuprofen was studied. Healthy adult volunteers were given a dose of zaleplon 10 mg alone, a dose of ibuprofen 600 mg alone, or a dose of zaleplon 10 mg and a dose of ibupro fen 600 mg concomitantly in an open-label, randomized, three-period crossov er study. There was a seven-day washout period between treatments. Venous b lood samples were collected for pharmacokinetic analysis at various interva ls up to 14 hours after drug administration. A total of 17 subjects (11 men and 6 women) completed the study. There were no significant differences between zaleplon monotherapy and combination th erapy in mean +/- S.D of zaleplon clearance (CL) (2.80 +/- 0.72 versus 2.72 +/- 0.89 L/hr/kg, respectively), maximum plasma concentration (C-max) (3.7 1 +/- 17.9 versus 39.8 +/- 20.0 ng/mL), or area under the concentration-ver sus-time curve (AUC) (56.7 +/- 22.8 versus 59.2 +/- 22.0 ng.hr/mL). There w ere no significant differences between ibuprofen monotherapy and combinatio n therapy in ibuprofen CL (71.6 +/- 17.0 versus 71.7 +/- 14.9 L/hr/kg), C-m ax (40.8 +/- 10.2 versus 40.4 +/- 10.0 mu g/mL), or Auc (127.6 +/- 29.6 ver sus 126.4 +/- 29.7 ug.hr/mL). Three subjects had one or more adverse effect s with zaleplon alone, one subject had one or more with ibuprofen alone, an d one subject had one or more with combination therapy. The adverse effects were mild and resolved without intervention. There was no evidence of a significant interaction between zaleplon and ibu profen.