S4 | Prescription Only

What Schedule Is CYCLOBENZAPRINE HYDROCHLORIDE?

CYCLOBENZAPRINE HYDROCHLORIDE scheduling and classification across Australia, United States, and international jurisdictions. Also known as CYCLOBENZAPRINE HYDROCHLORIDE.

S4 in Australia Source: FDA Updated April 2026

CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE) is classified as S4 (Prescription Only Medicine - requires a valid prescription from an authorised prescriber) under the Therapeutic Goods Administration (TGA) in Australia. It is FDA approved in the United States.

Key Takeaways

  • Australia (TGA): S4 - Prescription Only Medicine - requires a valid prescription from an authorised prescriber
  • United States (FDA): Approved (Rx only)
  • Risk level: Low (2 points)

Scheduling by Jurisdiction

Jurisdiction Regulatory Body Classification Status
Australia TGA (Therapeutic Goods Administration) S4 Not PBS listed
United States FDA / DEA Rx only (not DEA scheduled) FDA approved

What S4 Means for CYCLOBENZAPRINE HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE is classified as S4 under the TGA Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Prescription Only Medicine - requires a valid prescription from an authorised prescriber.

Schedule 4 Prescribing Requirements

  • Prescribing: Requires a valid prescription from a registered medical practitioner, dentist, or authorised prescriber.
  • Dispensing: Must be dispensed by a pharmacist against a valid prescription.
  • Repeats: Repeat prescriptions are permitted as specified by the prescriber.

Claims and Workers Compensation Implications

When CYCLOBENZAPRINE HYDROCHLORIDE (S4) appears on a claimant's medication list, the scheduling classification affects how claims professionals should assess and manage the claim.

As a Schedule 4 prescription medicine, claims professionals should verify that CYCLOBENZAPRINE HYDROCHLORIDE is being prescribed for the compensable injury and review duration against clinical guidelines. As a CNS depressant, it may affect work capacity and return-to-work timelines.

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Related Resources

Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.