Zopiclone

Sold as Sandoz zopiclone, Alchera, Adco zopimed, Propan zopiclone, Z-dorm, Zopivane, Zopigen, Z-dorm hs, Zopisleep, Bio zopiclone, Sedastell, Austovane, Zopiclone innovata, Zopiclone unicorn, Zopiclone austell

S5Read from the PI-PIL document and verified

C₁₇H₁₇ClN₆O₃388.80 g/mol

[6-(5-Chloro-2-pyridinyl)-5-oxo-7H-pyrrolo[3,4-b]pyrazin-7-yl] 4-methylpiperazine-1-carboxylate

Drag to rotate. Structure from PubChem CID 5735.

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Registration

Applicants: 11
Registrations: 17
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd	Sandoz zopiclone	7,5 mg	320487	S5	PI PIL
Pharmacare limited û woodmead	Alchera	Not stated	330029	S5	None
Adcock ingram limited1 of 2 cancelled	Adco zopimed, Propan zopiclone	Not stated	330450, 330451	S5	None
Kiara Health (Pty) Ltd	Z-dorm	Not stated	340421	S5	None
Cipla Medpro (Pty) LtdCertificate held by Cipla Medpro (Pty) Ltd.	Zopivane	7,5 mg	350021	S5	PI PIL
Viatris South Africa (Pty) Ltd	Zopigen	Not stated	360426	S5	None
Oethmaan Biosims (Pty) Ltd	Z-dorm hs	Not stated	360447	S5	None
Ipharma (Pty) Ltd	Zopisleep	7.5 mg	370375	S5	PI PIL
Biotech Laboratories (Pty) Ltd	Bio zopiclone	7,5 mg	420537	S5	PI PIL
Austell Pharmaceuticals (Pty) Ltd	Sedastell, Austovane, Zopiclone unicorn, Zopiclone austell	3,75 mg, 7,5 mg	430064, 430065, 430066, 430067, A390021, A390022	S5	None
Innovata pharmaceuticals	Zopiclone innovata	7,5	570124	S5	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Sandoz zopiclone 7,5 EACH TABLET CONTAINS ZOPICLONE 7,5 mg	7,5 mgFilm-coated tablets	32048732/2.2/0487Approved 22 June 2022	Registered	S5	PI PIL
Alchera EACH TABLET CONTAINS ZOPICLONE 7,5 mg	Not listed	33002933/2.2/0029	Registered	S5	None
Adco zopimed EACH TABLET CONTAINS ZOPICLONE 7,5 mg	Not listed	33045033/2.2/0450	Registered	S5	None
Propan zopiclone EACH TABLET CONTAINS ZOPICLONE 7,5 mg	Not listed	33045133/2.2/0451	Cancelled	S5	None
Z-dorm EACH TABLET CONTAINS ZOPICLONE 7,5 mg	Not listed	34042134/2.2/0421	Registered	S5	None
Zopivane EACH TABLET CONTAINS ZOPICLONE 7,5 mg	7,5 mgFilm-coated tablets	35002135/2.2/0021Approved 10 January 2023	Registered	S5	PI PIL
Zopigen EACH TABLET CONTAINS ZOPICLONE 7,5 mg	Not listed	36042636/2.2/0426	Registered	S5	None
Z-dorm hs EACH TABLET CONTAINS ZOPICLONE 3,75 Mg	Not listed	36044736/2.2/0447	Registered	S5	None
Zopisleep EACH TABLET CONTAINS ZOPICLONE 7,5 mg	7.5 mgFilm-coated tablet	37037537/2.2/0375Approved 1 December 2019	Registered	S5	PI PIL
Bio zopiclone 7,5 EACH TABLET CONTAINS ZOPICLONE 7,5 mg	7,5 mgFilm-coated tablets)	42053742/2.2/0537Approved 6 December 2022	Registered	S5	PI PIL
Sedastell 3,75 MG EACH TABLET CONTAINS ZOPICLONE 3,75 mg	3,75 mg	43006443/2.2/0064	Registered	S5	None
Sedastell 7,5 MG EACH TABLET CONTAINS ZOPICLONE 7,5 mg	7,5 mg	43006543/2.2/0065	Registered	S5	None
Austovane 3,75 MG EACH TABLET CONTAINS ZOPICLONE 3,75 mg	3,75 mg	43006643/2.2/0066	Registered	S5	None
Austovane 7,5 MG EACH TABLET CONTAINS ZOPICLONE 7,5 mg	7,5 mg	43006743/2.2/0067	Registered	S5	None
Zopiclone 7,5 innovata EACH TABLET CONTAINS ZOPICLONE 7,5 mg	7,5	57012457/2.2/0124	Registered	S5	None
Zopiclone 7,5 MG unicorn EACH TABLET CONTAINS ZOPICLONE 7,5 mg	7,5 MG	A390021A39/2.2/0021	Registered	S5	None
Zopiclone 7,5 MG austell EACH TABLET CONTAINS ZOPICLONE 7,5 mg	7,5 mg	A390022A39/2.2/0022	Registered	S5	None

Regulatory status

Where S5 sits on the scale

S0S1S2S3S4S5S6S7S8

Prescription-only, with tighter controls on repeats.

Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S5, read from the product's PI-PIL leaflet.

Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it.

Consolidated Schedules listings for Zopiclone

S5: Zopiclone
Consolidated Schedules 06 July 2026, line 9779

Pharmacological class: Sedatives, hypnotics. (class 2.2)

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Sandoz zopiclone 7,5, Sandoz South Africa (Pty) Ltd is scheduled S5 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsSandoz zopiclone 7,5, Sandoz South Africa (Pty) Ltd Patient information leaflet (PIL)For patients and carersSandoz zopiclone 7,5, Sandoz South Africa (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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