Active substance
Eszopiclone
- SFDA 3
- US FDA 15
- EMA 1
- Health Canada 9
- US price lines 3
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ZONAM 1 MG FILM-COATED TABLET | 1 mg | Film-coated tablet · Oral use | 28 Blister | SAR 13.95 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| ZONAM 2 MG FILM-COATED TABLET | 2 mg | Film-coated tablet · Oral use | 28 Blister | SAR 27.95 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
| ZONAM 3 MG FILM-COATED TABLET | 3 mg | Film-coated tablet · Oral use | 28 Blister | SAR 41.90 | Generic · Prescription | SPIMACO ADDWAEIH | Valid |
Indications — CHI Daman Drug Formulary
ANXIETY DISORDERS; INSOMNIA; JET LAG - INSOMNIA; SCHIZOPHRENIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LUNESTA | 1MG; 2MG; 3MG | tablet · oral | WAYLIS THERAP | Prescription | 15 Dec 2004 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | TEVA | Prescription | 23 May 2011 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | MYLAN PHARMS INC | Prescription | 26 Mar 2013 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | SUN PHARM | Prescription | 3 Apr 2013 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | DR REDDYS | Prescription | 15 Apr 2014 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | GLENMARK PHARMS LTD | Prescription | 15 Apr 2014 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | ORBION PHARMS | Prescription | 10 Jun 2014 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | MACLEODS PHARMS | Prescription | 30 Jan 2015 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | AUROBINDO PHARMA | Prescription | 15 Sep 2016 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | HETERO LABS LTD V | Prescription | 4 Jan 2024 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | CHARTWELL RX | Discontinued | 14 Jul 2011 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | LUPIN LTD | Discontinued | 13 Sep 2011 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | HIKMA PHARMS | Discontinued | 15 Apr 2014 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | PHARMOBEDIENT | Discontinued | 8 May 2019 |
| ESZOPICLONE | 1MG; 2MG; 3MG | tablet · oral | IPCA LABS LTD | Discontinued | 29 Dec 2023 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| LUNESTA | 02453207 | 1 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
| LUNESTA | 02453215 | 2 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
| LUNESTA | 02453223 | 3 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
| M-ESZOPICLONE | 02551187 | 1 MG | TABLET · ORAL | MANTRA PHARMA INC |
| M-ESZOPICLONE | 02551195 | 2 MG | TABLET · ORAL | MANTRA PHARMA INC |
| M-ESZOPICLONE | 02551209 | 3 MG | TABLET · ORAL | MANTRA PHARMA INC |
| MAR-ESZOPICLONE | 02549433 | 1 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-ESZOPICLONE | 02549441 | 2 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-ESZOPICLONE | 02549468 | 3 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ESZOPICLONE 1 MG TABLET | $0.0993 | per EA | 23 Sep 2026 |
| US NADAC | ESZOPICLONE 2 MG TABLET | $0.09096 | per EA | 23 Sep 2026 |
| US NADAC | ESZOPICLONE 3 MG TABLET | $0.0877 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 18 Aug 2019 LUNESTA — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.