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U.S. Department of Health and Human Services

Safety

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Ambien (zolpidem tartrate) Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

  • Abnormal thinking and behavioral changes
  • Special populations
    • Use in patients with concomitant illness

ADVERSE REACTIONS

  • Clinical trials experience
  • Adverse event incidence across the entire preapproval database
    • Body as a whole
      • Fatigue
    • Central and peripheral nervous system
      • headache
      • anxiety
      • nervousness
    • Gastrointestinal system
      • dyspepsia
      • nausea
      • anorexia
      • vomiting
    • Immunologic system
      • Infection (infrequent)
    • Musculoskeletal system
    • Frequent
      • arthralgia
      • myalgia
    • Respiratory system
      • upper respiratory infection (frequent)
      • rhinitis
    • Urogenital system
      • urinary tract infection (frequent)

DRUG INTERACTIONS

  • Drugs that affect drug metabolism via cytochrome P450
  • Drug-laboratory test interactions

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Nursing mothers
  • Pediatric use
  • Geriatric use

PATIENT COUNSELING INFORMATION

  • Severe anaphylactic and anaphylactoid reactions
  • Sleep-driving and other complex behaviors
  • Administration instructions

MEDICATION GUIDE

CONTRAINDICATIONS

...Observed reactions include anaphylaxis and angioedema.

WARNINGS AND PRECAUTIONS

Abnormal thinking and behavioral changes

Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem...

Special populations: Use in patients with concomitant illness

...Since sedative/hypnotics have the capacity to depress respiratory drive, precautions should be taken if Ambien is prescribed to patients with compromised respiratory function...

...Ambien should be used with caution in patients with sleep apnea syndrome or myasthenia gravis.