Regulatory PathRegulatory requirements compared

Active substance

Zopiclone

Open in the medicines table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-ZOPICLONE024758395 MGTABLET · ORALANGITA PHARMA INC.
AG-ZOPICLONE024758477.5 MGTABLET · ORALANGITA PHARMA INC.
ALTA-ZOPICLONE024684925 MGTABLET · ORALALTAMED PHARMA
ALTA-ZOPICLONE024691547.5 MGTABLET · ORALALTAMED PHARMA
APO-ZOPICLONE022183137.5 MGTABLET · ORALAPOTEX INC
APO-ZOPICLONE022450775 MGTABLET · ORALAPOTEX INC
BIO-ZOPICLONE024810065 MGTABLET · ORALBIOMED PHARMA
BIO-ZOPICLONE024810147.5 MGTABLET · ORALBIOMED PHARMA
IMOVANE019267997.5 MGTABLET · ORALSANOFI-AVENTIS CANADA INC
JAMP ZOPICLONE025492713.75 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP ZOPICLONE025492985 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP ZOPICLONE025493017.5 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP-ZOPICLONE TABLETS024069695 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP-ZOPICLONE TABLETS024069777.5 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP-ZOPICLONE TABLETS024683953.75 MGTABLET · ORALJAMP PHARMA CORPORATION
M-ZOPICLONE024679415 MGTABLET · ORALMANTRA PHARMA INC
M-ZOPICLONE024679687.5 MGTABLET · ORALMANTRA PHARMA INC
MAR-ZOPICLONE023867715 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MAR-ZOPICLONE023867987.5 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
MINT-ZOPICLONE023917165 MGTABLET · ORALMINT PHARMACEUTICALS INC
MINT-ZOPICLONE023917247.5 MGTABLET · ORALMINT PHARMACEUTICALS INC
NRA-ZOPICLONE024773785 MGTABLET · ORALNORA PHARMA INC
NRA-ZOPICLONE024773867.5 MGTABLET · ORALNORA PHARMA INC
PMS-ZOPICLONE022406067.5 MGTABLET · ORALPHARMASCIENCE INC
PMS-ZOPICLONE022434265 MGTABLET · ORALPHARMASCIENCE INC

11 more — full table

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
ZIMOVANE 7.5MG FILM-COATED TABLETSPL 04425/0624AVENTIS PHARMA LIMITEDPOM
ZOPICLONE 3.75 MG FILM-COATED TABLETSPL 16363/0541MILPHARM LIMITEDPOM
ZOPICLONE 3.75 MG FILM-COATED TABLETSPL 28278/0118IPCA LABORATORIES UK LIMITEDPOM
ZOPICLONE 3.75 MG FILM-COATED TABLETSPL 43461/0021FLAMINGO PHARMA (UK) LIMITEDPOM
ZOPICLONE 3.75 MG TABLETSPL 20117/0268MORNINGSIDE HEALTHCARE LIMITEDPOM
ZOPICLONE 3.75MG FILM-COATED TABLETSPL 15764/0184STRANDHAVEN LIMITEDPOM
ZOPICLONE 3.75MG FILM-COATED TABLETSPL 17907/0122BRISTOL LABORATORIES LIMITEDPOM
ZOPICLONE 3.75MG FILM-COATED TABLETSPL 20416/0797CRESCENT PHARMA LIMITEDPOM
ZOPICLONE 3.75MG FILM-COATED TABLETSPL 54022/0011MOBIUS HEALTHCARE LIMITEDPOM
ZOPICLONE 3.75MG TABLETSPL 00142/0449ACCORD-UK LIMITEDPOM
ZOPICLONE 3.75MG TABLETSPL 00289/2548TEVA UK LIMITEDPOM
ZOPICLONE 3.75MG TABLETSPL 04569/0450GENERICS (UK) LIMITEDPOM
ZOPICLONE 3.75MG TABLETSPL 36282/0017RIA GENERICS LIMITEDPOM
ZOPICLONE 7.5 MG FILM-COATED TABLETSPL 16363/0542MILPHARM LIMITEDPOM
ZOPICLONE 7.5 MG FILM-COATED TABLETSPL 20416/0551CRESCENT PHARMA LIMITEDPOM
ZOPICLONE 7.5 MG FILM-COATED TABLETSPL 43461/0022FLAMINGO PHARMA (UK) LIMITEDPOM
ZOPICLONE 7.5 MG FILM-COATED TABLETSPL 55503/0018JUBILANT PHARMA UK LIMITEDPOM
ZOPICLONE 7.5 MG TABLETSPL 20117/0269MORNINGSIDE HEALTHCARE LIMITEDPOM
ZOPICLONE 7.5MG FILM-COATED TABLETSPL 15764/0185STRANDHAVEN LIMITEDPOM
ZOPICLONE 7.5MG FILM-COATED TABLETSPL 17907/0051BRISTOL LABORATORIES LIMITEDPOM
ZOPICLONE 7.5MG FILM-COATED TABLETSPL 28278/0050IPCA LABORATORIES UK LIMITEDPOM
ZOPICLONE 7.5MG FILM-COATED TABLETSPL 54022/0012MOBIUS HEALTHCARE LIMITEDPOM
ZOPICLONE 7.5MG TABLETSPL 00142/0434ACCORD-UK LIMITEDPOM
ZOPICLONE 7.5MG TABLETSPL 00289/2549TEVA UK LIMITEDPOM
ZOPICLONE 7.5MG TABLETSPL 04569/0382GENERICS (UK) LIMITEDPOM

4 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffZopiclone 3.75mg tablets£0.9428 tablet1 Oct 2026
NHS Drug TariffZopiclone 7.5mg tablets£1.0328 tablet1 Oct 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.

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.