Drug facts
MoleculeZolpidem (Ambien)
Generics already compete: 12 makers on the market. 27 A-rated products from 12 makers substitute at the counter.
Ambien was first approved by the FDA on 12/16/1992 under NDA 019908; the application holder is Cosette Pharmaceuticals Inc.
The latest NADAC for ZOLPIDEM TARTRATE 5 MG TABLET is $0.03 per unit (as of 10/28/2026).
Holder Cosette Pharmaceuticals IncApplication NDA 019908Approved 12/16/1992
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
- Latest patent
- No Ambien patent listed in the Orange Book Orange Book
- Later patents, other products
- Zolpimist 08/07/2032; Edluar 02/25/2031; Intermezzo 08/20/2029 Orange Book
02Competition
- Generics
- 12 generic makers Orange Book
- First generic approved
- 04/23/2007 Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Zolpidem profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.03 per unitZOLPIDEM TARTRATE 5 MG TABLET, as of 10/28/2026 CMS NADAC
- Latest recall
- 01/18/2024Class II, Zolpidem Tartrate, Sun Pharmaceutical Industries Inc FDA enforcement
04Product
- Application holder
- Cosette Pharmaceuticals Inc Orange Book
- Application
- NDA 019908 Orange Book
- First approved
- 12/16/1992 Orange Book
- Dosage forms
- capsule; tablet; tablet, extended release
- Routes
- oral, sublingual
- Other brand names
- Ambien CREdluar
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.