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Zolpidem extended release - Cosette Pharmaceuticals/Sanofi-aventis

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Drug Profile

Zolpidem extended release - Cosette Pharmaceuticals/Sanofi-aventis

Alternative Names: Ambien CR; FK-199B; Stilnox; Zolpidem controlled release; Zolpidem tartrate extended-release; Zolpidem XR

Latest Information Update: 15 Jul 2024

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At a glance

  • Originator sanofi-aventis
  • Developer Astellas Pharma; Sanofi
  • Class Acetamides; Hypnosedatives; Imidazoles; 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Insomnia

Most Recent Events

  • 10 Jul 2024 Cosette Pharmaceuticals acquires Zolpidem extended release tablets from Sanofi in USA
  • 30 Apr 2019 The FDA recommends to update the label of zolpidem extended release (Ambien CR®) for Insomnia to include Black Box warning regarding the complex sleep behaviors
  • 07 Mar 2014 Pharmacovigilance Risk Assessment Committee recommends amendments to product information for zolpidem extended-release for Insomnia in the European Union

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