🇺🇸 Rozerem in United States

FDA authorised Rozerem on 22 July 2005 · 3,602 US adverse-event reports

Marketing authorisations

FDA — authorised 22 July 2005

  • Application: NDA021782
  • Marketing authorisation holder: TAKEDA PHARMS USA
  • Status: supplemented

FDA

  • Status: approved

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 — 850 reports (23.6%)
  2. Initial Insomnia — 441 reports (12.24%)
  3. Middle Insomnia — 387 reports (10.74%)
  4. Somnolence — 378 reports (10.49%)
  5. Insomnia — 339 reports (9.41%)
  6. Nausea — 273 reports (7.58%)
  7. Dizziness — 252 reports (7%)
  8. Fatigue — 238 reports (6.61%)
  9. Headache — 229 reports (6.36%)
  10. Poor Quality Sleep — 215 reports (5.97%)

Source database →

Other Neuroscience approved in United States

Frequently asked questions

Is Rozerem approved in United States?

Yes. FDA authorised it on 22 July 2005; FDA has authorised it.

Who is the marketing authorisation holder for Rozerem in United States?

TAKEDA PHARMS USA holds the US marketing authorisation.