Label Changes for:

Ambien CR (Zolpidem Tartrate) Extended-release Tablets

April 2013

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

 

CONTRAINDICATIONS

  • Ambien CR is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema
 
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