Safety

Ambien (Zolpidem Tartrate) Tablets

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

October 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.8 Severe Injuries
  • Zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries. Severe injuries such as hip fractures and intracranial hemorrhage have been reported.

 

April 2013

Summary View 

CONTRAINDICATIONS

  • Ambien 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, 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 - In controlled trials of Ambien 10 mg taken at bedtime < 1% of adults with insomnia reported hallucinations. In a clinical trial, 7% of pediatric patients treated with Ambien 0.25 mg/kg taken at bedtime reported hallucinations versus 0% treated with placebo…
  •  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…