Zolpidem hemitartrate
Sold as Stilnox, Adco-zolpidem hemitartrate
N,N-Dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide
Drag to rotate. Structure from PubChem CID 5732.
Background
Registration
- Applicants
- 2
- Registrations
- 3
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Stilnox EACH TABLET CONTAINS ZOLPIDEM HEMITARTRATE 10 mg | 10 mgFilm-coated tablets. | 29065129/2.2/0651Approved 15 June 2023 | Registered | S5 | PIPIL |
| Adco-zolpidem hemitartrate 5 MG EACH TABLET CONTAINS ZOLPIDEM HEMITARTRATE 5,0 mg | 5 mg | 36013136/2.2/0131 | Registered | S5 | None |
| Adco-zolpidem hemitartrate 10 MG EACH TABLET CONTAINS ZOLPIDEM HEMITARTRATE 10,0 mg | 10 mg | 36013236/2.2/0132 | Registered | S5 | None |
Regulatory status
Where S5 sits on the scale
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 Zolpidem hemitartrate
S5: Zolpidem
Consolidated Schedules 06 July 2026, line 9777
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 Verification
Stilnox, Sanofi-aventis South Africa (Pty) Ltd is scheduled S5 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.