Overview
Eszopiclone, marketed by Sepracor under the brand-name Lunesta, is a nonbenzodiazepine hypnotic drug used to treat insomnia. It is the active stereoisomer of zopiclone, belonging to the class of drugs known as cyclopyrrolones. Cyclopyrrolone drugs demonstrate high efficacy and low toxicity, offering a safer alternative to other drugs used for insomnia. One major benefit of eszopiclone is that it is approved by the FDA for the long-term treatment of insomnia. This sets it apart from many other hypnotic sedatives, which are generally approved only for the relief of short-term (6-8 weeks) insomnia. Eszopiclone was initially approved by the FDA in 2004.
Background
Eszopiclone, marketed by Sepracor under the brand-name Lunesta, is a nonbenzodiazepine hypnotic drug used to treat insomnia. It is the active stereoisomer of zopiclone, belonging to the class of drugs known as cyclopyrrolones. Cyclopyrrolone drugs demonstrate high efficacy and low toxicity, offering a safer alternative to other drugs used for insomnia. One major benefit of eszopiclone is that it is approved by the FDA for the long-term treatment of insomnia. This sets it apart from many other hypnotic sedatives, which are generally approved only for the relief of short-term (6-8 weeks) insomnia. Eszopiclone was initially approved by the FDA in 2004.
Indication
Eszopiclone is indicated for the treatment of insomnia.
Associated Conditions
- Insomnia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/12 | Phase 4 | Recruiting | |||
2025/04/15 | Phase 2 | Not yet recruiting | |||
2024/06/11 | Not Applicable | Completed | Central South University | ||
2023/08/30 | Phase 4 | Recruiting | |||
2023/07/20 | Phase 2 | Recruiting | |||
2023/07/18 | Phase 2 | Recruiting | |||
2022/04/27 | Phase 1 | Completed | |||
2021/05/06 | Phase 2 | Recruiting | |||
2020/11/20 | Phase 2 | Completed | |||
2019/05/06 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Preferred Pharmaceuticals, Inc. | 68788-7667 | ORAL | 1 mg in 1 1 | 5/24/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-795 | ORAL | 3 mg in 1 1 | 9/19/2023 | |
| Unit Dose Services | 50436-0320 | ORAL | 1 mg in 1 1 | 7/24/2017 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0067 | ORAL | 3 mg in 1 1 | 1/19/2023 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0168 | ORAL | 1 mg in 1 1 | 4/5/2023 | |
| DirectRX | 61919-991 | ORAL | 1 mg in 1 1 | 2/8/2022 | |
| Lupin Pharmaceuticals, Inc. | 68180-324 | ORAL | 3 mg in 1 1 | 1/17/2024 | |
| Proficient Rx LP | 71205-513 | ORAL | 2 mg in 1 1 | 12/1/2020 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-185 | ORAL | 3 mg in 1 1 | 6/29/2016 | |
| DIRECT RX | 61919-033 | ORAL | 2 mg in 1 1 | 3/29/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dexzopiclone Tablets | 国药准字H20213830 | 化学药品 | 片剂 | 10/26/2021 | |
| Dexzopiclone Tablets | 国药准字H20070069 | 化学药品 | 片剂 | 9/9/2021 | |
| Dexzopiclone Tablets | 国药准字H20233905 | 化学药品 | 片剂 | 6/30/2023 | |
| Dexzopiclone Tablets | 国药准字H20120001 | 化学药品 | 片剂 | 1/12/2022 | |
| Dexzopiclone Tablets | 国药准字H20090209 | 化学药品 | 片剂 | 11/7/2023 | |
| Dexzopiclone Tablets | 国药准字H20100074 | 化学药品 | 片剂 | 4/15/2020 | |
| Dexzopiclone Tablets | 国药准字H20213536 | 化学药品 | 片剂 | 6/22/2021 | |
| Dexzopiclone Tablets | 国药准字H20213535 | 化学药品 | 片剂 | 6/22/2021 | |
| Dexzopiclone Tablets | 国药准字H20213534 | 化学药品 | 片剂 | 6/22/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Eszopiclone 1 mg Tablet Bottle | 219346 | Medicine | A | 1/16/2014 | |
| Eszopiclone 3 mg Tablet Bottle | 219348 | Medicine | A | 1/16/2014 | |
| Eszopiclone 2 mg Tablet Bottle | 219347 | Medicine | A | 1/16/2014 |