Zolpidem
As of the edition of 20 October 2026, Zolpidem is a small molecule: marketed, first approved in 1987 (FR); acts on GABRA1 and GABRG2; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Ambien
- First approved
- 9 June 1987 (FR)
- Approvals on record
- 18 in 4 regions
- Holder of the most recent approval
- Almatica Pharma; 9 holders in all
- Registered trials
- 95, 9 stopped early
- Disease areas
- Nervous system; Mental health; Cancer; Chemically induced; Heart and blood vessels; Injuries
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Aytu BioPharma holds a later exclusivity on its own new formulation or combination product, ending 2032; it does not protect the original drug.
This is the US only.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 16 | 13 | 0 | 1 |
| Phase 1 | 20 | 18 | 0 | 1 |
| Phase 2 | 12 | 8 | 2 | 2 |
| Phase 3 | 14 | 10 | 1 | 2 |
| Phase 4 | 33 | 26 | 2 | 3 |
| All trials | 95 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Later holder and Lead sponsor of trials | 2003 to now |
| Transcept Pharmaceuticals | Later holder and Lead sponsor of trials | 2006 to now |
| Bausch Health | Acquired holder and Later holder | 2007 to now |
| Orexo | Later holder | 2009 to now |
| Purdue Pharma | Acquired holder | 2012 to now |
| Aytu BioPharma | Acquired holder | 2019 to now |
| Almatica Pharma | Later holder | 2023 to now |
| Cosette Pharmaceuticals | Acquired holder | 2025 to now |
| Viatris | Acquired holder | 2025 to now |