Zolpidem extended release - sanofi-aventis

Drug Profile

Zolpidem extended release - sanofi-aventis

Alternative Names: Ambien CR; FK199B; Stilnox; Zolpidem controlled release; Zolpidem tartrate extended-release; Zolpidem XR

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator sanofi-aventis
  • Developer Astellas Pharma; Sanofi
  • Class Acetamides; Hypnosedatives; Pyridines; Sleep disorder therapies; Small molecules
  • Mechanism of Action GABA A receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Insomnia

Most Recent Events

  • 29 Apr 2016 Biomarkers information updated
  • 07 Mar 2014 Pharmacovigilance Risk Assessment Committee recommends amendments to product information for zolpidem extended-release for Insomnia in the European Union
  • 18 Oct 2010 First Generic equivalent available in USA for Insomnia
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