SEVERE ANAPHYLACTIC AND ANAPHYLACTOID REACTIONS

SEVERE ANAPHYLACTIC AND ANAPHYLACTOID REACTIONS

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with Zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immedidately if any of them occur.

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 you experience such an event, it should be reported to your 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 . Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in people who are not fully awake after taking a sedative-hypnotic. As with “sleep-driving”, people usually do not remember these events.

Patients should be instructed NOT to take Zolpidem tartrate tablets or other sedative-hypnotics 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.

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