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U.S. Department of Health and Human Services

Safety

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Ambien CR (Zolpidem Tartrate) Extended-release Tablets

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

Summary View

 

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

  • CNS Depressant Effects and Next-Day Impairment – Ambien CR, 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…
  • Abnormal Thinking and Behavioral Changes - Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including Ambien CR…
  • Use in Patients with Depression - In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides), have been reported…
  • Respiratory Depression - Although studies with 10 mg Zolpidem tartrate did not reveal respiratory depressant effects at hypnotic doses in healthy subjects or in patients with mild-to-moderate chronic obstructive pulmonary disease (COPD), a reduction in the Total Arousal Index…
  • Withdrawal Effects - There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of Zolpidem. Monitor patients for tolerance, abuse, and dependence.
 

ADVERSE REACTIONS

Adverse event incidence across the entire preapproval database:
Respiratory System
  • lower respiratory infection
  • respiratory depression
 

USE IN SPECIFIC POPULATIONS

Gender Difference in Pharmacokinetics
  • Women clear Zolpidem Tartrate from the body at a lower rate than men. Cmax and AUC parameters of Zolpidem from Ambien CR were, respectively, approximately 50% and 75% higher at the same dose in adult female subjects compared to adult male subjects…