ZOLPIDEM TARTRATE- zolpidem tartrate tablet 
InvaGen Pharmaceuticals Inc.,


17.1 “Sleep-Driving” and other complex behaviors

There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep-driving” can be dangerous. This behavior is more likely to occur when zolpidem tartrate tablets are taken with alcohol or other central nervous system depressants [see Warnings (5.3)]. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with “sleep-driving”, patients usually do not remember these events.

Patients should be instructed NOT to take zolpidem tartrate tablets or other sedativehypnotics when drinking alcohol. In addition, patients should be advised to report all concomitant medications to the prescriber. Patients should be counseled to take zolpidem tartrate tablets right before they get in bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Patients should be instructed to report events such as sleep-driving and other complex behaviors immediately to the prescriber.

Revised: 2/2008
InvaGen Pharmaceuticals Inc.,