Zolpidem
Sold as Noxidem, Zolpihexal, Zolnoxs, Ivedal, Redinoct, Medploz, Nyxe, Zolpidem austell, Zolpidem apex, Zolpidem camox, Zolnorem, * zolpidem mr unicorn, Zilsun mr, Zolpidem mr sun, Zoltab, Zolpidem unicorn, Zolpidem xr adco, Mylan zolpidem, Ivedal mr
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
- 14
- Registrations
- 25
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sandoz South Africa (Pty) Ltd | Noxidem | 10 | 360087 | S5 | None |
| Hexal Pharma (SA) (Pty) Ltd | Zolpihexal | 10 | 360095 | S5 | None |
| Pharmacare limited û woodmead | Zolnoxs | 10 mg | 360328 | S5 | None |
| Sanofi-aventis South Africa (Pty) Ltd1 of 2 cancelled | Ivedal, Ivedal mr | 10 mg, 12,5 | 370540, A400443 | S5 | PIPIL |
| Dr Reddyæs Laboratories (Pty) LtdCancelled | Redinoct | 10 | 420721 | S5 | None |
| Aurogen South Africa (Pty) Ltd | Medploz | 5 mg, 10 mg | 430247, 430257 | S5 | None |
| Novagen Pharma (Pty) Ltd1 of 2 cancelled | Nyxe | 5 mg, 10 mg | 430248, 430258 | S5 | None |
| Austell Pharmaceuticals (Pty) Ltd | Zolpidem austell, Zolpidem apex, Zolpidem camox | 5 MG, 10 MG | 500218, 500219, 500220, 500221, 500222, 500223 | S5 | None |
| Pharma Dynamics (Pty) Ltd | Zolnorem, * zolpidem mr unicorn | 12,5 mg | 540178, 540180.178 | S5 | PIPIL |
| Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd | Zilsun mr, Zolpidem mr sun | 12,5 mg | 540324, 540325.324 | S5 | PIPIL |
| Ascend Laboratories (Pty) Ltd | Zoltab | 5, 10 | 550136, 550137 | S5 | None |
| Unicorn Pharmaceuticals (Pty) Ltd | Zolpidem unicorn | 10 mg | 560729 | S5 | PIPIL |
| Adcock ingram limited | Zolpidem xr adco | 12,5 | 570188 | S5 | None |
| Viatris South Africa (Pty) LtdCancelled | Mylan zolpidem | Not stated | A390348 | S5 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Noxidem 10 EACH TABLET CONTAINS ZOLPIDEM TARTRATE 10,0 mg | 10 | 36008736/2.2/0087 | Registered | S5 | None |
| Zolpihexal 10 EACH TABLET CONTAINS ZOLPIDEM TARTRATE 10,0 mg | 10 | 36009536/2.2/0095 | Registered | S5 | None |
| Zolnoxs 10 MG tablets EACH TABLET CONTAINS ZOLPIDEM EQUIVALENT TO ZOLPIDEM TARTRATE 10,0 mg | 10 mgTablets | 36032836/2.2/0328 | Registered | S5 | None |
| Ivedal EACH TABLET CONTAINS ZOLPIDEM 10,0 mg | 10 mgFilm-coated tablets. | 37054037/2.2/0540Approved 1 July 2022 | Registered | S5 | PIPIL |
| Redinoct 10 EACH TABLET CONTAINS ZOLPIDEM TARTRATE 10,0 mg | 10 | 42072142/2.2/0721 | Cancelled | S5 | None |
| Medploz 5 MG EACH TABLET CONTAINS ZOLPIDEM 5,0 mg | 5 mg | 43024743/2.2/0247 | Registered | S5 | None |
| Nyxe 10 MG EACH TABLET CONTAINS ZOLPIDEM 10,0 mg | 10 mg | 43024843/2.2/0248 | Registered | S5 | None |
| Medploz 10 MG EACH TABLET CONTAINS ZOLPIDEM 10,0 mg | 10 mg | 43025743/2.2/0257 | Registered | S5 | None |
| Nyxe 5 MG EACH TABLET CONTAINS ZOLPIDEM 5,0 mg | 5 mg | 43025843/2.2/0258 | Cancelled | S5 | None |
| Zolpidem 5 MG austell Each tablet contains ZOLPIDEM TARTRATE 5,0 mg | 5 MG | 50021850/2.2/0218 | Registered | S5 | None |
| Zolpidem 10 MG austell Each tablet contains ZOLPIDEM TARTRATE 10,0 mg | 10 MG | 50021950/2.2/0219 | Registered | S5 | None |
| Zolpidem 5 MG apex Each tablet contains ZOLPIDEM TARTRATE 5,0 mg | 5 MG | 50022050/2.2/0220 | Registered | S5 | None |
| Zolpidem 10 MG apex Each tablet contains ZOLPIDEM TARTRATE 10,0 mg | 10 MG | 50022150/2.2/0221 | Registered | S5 | None |
| Zolpidem 5 MG camox Each tablet contains ZOLPIDEM TARTRATE 5,0 mg | 5 MG | 50022250/2.2/0222 | Registered | S5 | None |
| Zolpidem 10 MG camox Each tablet contains ZOLPIDEM TARTRATE 10,0 mg | 10 MG | 50022350/2.2/0223 | Registered | S5 | None |
| Zolnorem 12,5 MG EACH TABLET CONTAINS ZOLPIDEM TARTRATE 12,5 mg | 12,5 mgTablet | 54017854/2.2/0178Approved 5 September 2023 | Registered | S5 | PIPIL |
| * zolpidem 12,5 MG mr unicorn EACH TABLET CONTAINS: ZOLPIDEM TARTRATE 12,5 mg | 12,5 mg | 540180.17854/2.2/0180.178 | Registered | S5 | None |
| Zilsun mr EACH TABLET CONTAINS ZOLPIDEM TARTRATE 12,5 mg | 12,5 mgTablet | 54032454/2.2/0324Approved 3 October 2023 | Registered | S5 | PIPIL |
| Zolpidem mr sun EACH TABLET CONTAINS ZOLPIDEM TARTRATE 12,5 mg | 12,5 mgTablet | 540325.32454/2.2/0325.324Approved 3 October 2023 | Registered | S5 | PIPIL |
| Zoltab 5 EACH TABLET CONTAINS ZOLPIDEM 5,0 mg | 5 | 55013655/2.2/0136 | Registered | S5 | None |
| Zoltab 10 EACH TABLET CONTAINS ZOLPIDEM 10,0 mg | 10 | 55013755/2.2/0137 | Registered | S5 | None |
| Zolpidem 10 unicorn EACH TABLET CONTAINS ZOLPIDEM TARTRATE EQUIVALENT TO ZOLPIDEM 10,0 mg | 10 mgFilm coated tablets | 56072956/2.2/0729Approved 25 March 2025 | Registered | S5 | PIPIL |
| Zolpidem xr 12,5 adco EACH TABLET CONTAINS ZOLPIDEM TARTRATE 12,5 mg | 12,5 | 57018857/2.2/0188 | Registered | S5 | None |
| Mylan zolpidem EACH TABLET CONTAINS ZOLPIDEM TARTRATE 10,0 mg | Not listed | A390348A39/2.2/0348 | Cancelled | S5 | None |
| Ivedal mr 12,5 EACH TABLET CONTAINS ZOLPIDEM TARTRATE 12,5 mg | 12,5 | A400443A40/2.2/0443 | Cancelled | 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, matched to the Consolidated Schedules by ingredient, confidence high.
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 tartrate
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.