Nitrazepam
Sold as Mogadon, Lyladorm, Ormodon, Arem, Hypnotin, Paxadorm, Nitrapin
7-Nitro-5-phenyl-1,3-dihydro-1,4-benzodiazepin-2-one
Drag to rotate. Structure from PubChem CID 4506.
Background
Registration
- Applicants
- 5
- Registrations
- 8
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Trinity Pharma (Pty) Ltd | Mogadon | 5 mg | B1005 | S4 | PIPIL |
| Pharmacare limited û woodmeadCancelled | Lyladorm | Not stated | K0020 | S5 | None |
| Pharmachem Pharmaceuticals CC | Ormodon | Not stated | K0140 | S5 | None |
| Adcock ingram limited | Arem, Hypnotin | 5 mg, 10 mg | K0210, L0006, Q0099 | S5 | PIPIL |
| Alliance Pharma (Pty) Ltd1 of 2 cancelled | Paxadorm, Nitrapin | Not stated | R0007, S0203 | S5 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Mogadon Each tablet contains 5 mg nitrazepam | 5 mgTablet | B1005Approved 26 October 2022 | Old Medicine | S4 | PIPIL |
| Lyladorm EACH TABLET CONTAINS NITRAZEPAM 5 mg | Not listed | K0020K/2.2/20 | Cancelled | S5 | None |
| Ormodon EACH TABLET CONTAINS NITRAZEPAM 5 mg | Not listed | K0140K/2.2/140 | Registered | S5 | None |
| Arem EACH TABLET CONTAINS NITRAZEPAM 5 MG | 5 mgTablets | K0210K/2.2/210Approved 23 December 2022 | Registered | S5 | PIPIL |
| Hypnotin EACH TABLET CONTAINS NITRAZEPAM 5,0 mg | Not listed | L0006L/2.2/6 | Registered | S5 | None |
| Arem 10 MG EACH TABLET CONTAINS NITRAZEPAM 10 mg | 10 mg | Q0099Q/2.2/99 | Registered | S5 | None |
| Paxadorm EACH CAPSULE CONTAINS NITRAZEPAM 5,0 mg | Not listed | R0007R/2.2/7 | Registered | S5 | None |
| Nitrapin EACH CAPSULE CONTAINS NITRAZEPAM 5 mg | Not listed | S0203S/2.2/203 | 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 Nitrazepam
S5: Nitrazepam
Consolidated Schedules 06 July 2026, line 9584
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
Mogadon, Trinity Pharma (Pty) Ltd is scheduled S4 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.