Zopiclone
As of the edition of 20 October 2026, Zopiclone is a small molecule: marketed, first approved in 1984 (FR); acts on GABRA1, GABRA2 and GABRA3 and 3 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Imovane
- First approved
- 10 December 1984 (FR)
- Approvals on record
- 5 in 5 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Withdrawn from market
- 1 January 1987 (in some regions)
- Registered trials
- 20, 3 stopped early
- Disease areas
- Mental health; Nervous system; Lungs and airways; Cancer; Heart and blood vessels; Hormones
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| GABRA1 | Gamma-aminobutyric acid receptor subunit alpha-1 | P14867 |
| GABRA5 | Gamma-aminobutyric acid receptor subunit alpha-5 | P31644 |
| GABRA3 | Gamma-aminobutyric acid receptor subunit alpha-3 | P34903 |
| GABRA2 | Gamma-aminobutyric acid receptor subunit alpha-2 | P47869 |
| GABRA4 | Gamma-aminobutyric acid receptor subunit alpha-4 | P48169 |
| GABRA6 | Gamma-aminobutyric acid receptor subunit alpha-6 | Q16445 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 1 |
| Phase 1 | 9 | 8 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 4 | 3 | 0 | 1 |
| Phase 4 | 3 | 2 | 0 | 1 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant | 1990 to now |