🇺🇸 Zolpidem CR in United States

FDA authorised Zolpidem CR on 2 September 2005 · 29 US adverse-event reports

Marketing authorisation

FDA — authorised 2 September 2005

  • Application: NDA021774
  • Marketing authorisation holder: COSETTE
  • Local brand name: AMBIEN CR
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

Read official source →

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 6 reports (20.69%)
  2. Fall — 4 reports (13.79%)
  3. Decreased Appetite — 3 reports (10.34%)
  4. Product Substitution Issue — 3 reports (10.34%)
  5. Serotonin Syndrome — 3 reports (10.34%)
  6. Abnormal Behaviour — 2 reports (6.9%)
  7. Ankle Fracture — 2 reports (6.9%)
  8. Confusional State — 2 reports (6.9%)
  9. Deep Vein Thrombosis — 2 reports (6.9%)
  10. Delirium — 2 reports (6.9%)

Source database →

Frequently asked questions

Is Zolpidem CR approved in United States?

Yes. FDA authorised it on 2 September 2005.

Who is the marketing authorisation holder for Zolpidem CR in United States?

COSETTE holds the US marketing authorisation.