Label Changes for:

Edluar (Zolpidem Tartrate) Sublingual Tablets

April 2013

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

 

WARNINGS AND PRECAUTIONS

CNS Depressant Effects and Next-Day Impairment
  • Edluar, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression…

 

Hide
(web4)