Drug Profile
Zolpidem extended release - sanofi-aventis
Alternative Names: Ambien CR; FK199B; Stilnox; Zolpidem controlled release; Zolpidem tartrate extended-release; Zolpidem XRLatest Information Update: 05 Nov 2023
Price :
$50
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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
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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
- 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
- 18 Oct 2010 First Generic equivalent available in USA for Insomnia