Table 6

TEAE that occurred in ≥5% of subjects in any treatment group

TEAEsNo. of Events
Zolpidem (N= 50)Fluoxetine (N = 50)Zolpidem + Fluoxetine (N = 29)
Anorexia0  (0.0%)7  (14.0%)0  (0.0%)
Dizziness0  (0.0%)0  (0.0%)2  (6.9%)
Diplopia1  (2.0%)0  (0.0%)2  (6.9%)
Erythema multiforme0  (0.0%)0  (0.0%)2  (6.9%)
Headache1  (2.0%)5  (10.0%)5  (17.2%)
Insomnia0  (0.0%)3  (6.0%)0  (0.0%)
Nausea1  (2.0%)7  (14.0%)1  (3.4%)
Pharyngitis0  (0.0%)0  (0.0%)2  (6.9)
Teeth grinding0  (0.0%)3  (6.0%)0  (0.0%)
Overall7  (14.0%)21  (42.0%)15  (51.7%)