Solriamfetol, marketed under the brand name Sunosi, is a newer wakefulness-promoting medication approved in the United States and European Union for excessive daytime sleepiness (EDS) associated with narcolepsy and obstructive sleep apnea (OSA). Its novel action as a dopamine–norepinephrine reuptake inhibitor (DNRI) differentiates it from traditional stimulants. However, its availability and regulation vary across countries. The legal status of Solriamfetol In Australia, remains restrictive, shaping how patients can access treatment.
1. Solriamfetol’s Legal Status in Australia
- Not Registered with the ARTG: Solriamfetol does not appear on the Australian Register of Therapeutic Goods (ARTG), the official list of medicines approved by the Therapeutic Goods Administration (TGA).
- Unavailable via Standard Prescription: Since it lacks ARTG registration, doctors cannot prescribe or pharmacies dispense it under normal conditions.
- Special Access Schemes: In rare cases, a clinician might apply through the TGA Special Access Scheme or Section 19A exemptions to import Solriamfetol for an individual patient, but this is uncommon and tightly regulated.
2. Alternatives Approved in Australia
Since Solriamfetol is not legally available, patients and clinicians often rely on established alternatives that are approved for managing narcolepsy and EDS:
a) Modafinil
- Status: Fully registered with the ARTG and available on prescription.
- Indications: Approved for narcolepsy, OSA-related EDS, and shift work sleep disorder.
- Advantages:
- Widely prescribed in Australia.
- Subsidized under the Pharmaceutical Benefits Scheme (PBS) for certain conditions, reducing cost.
- Considered effective and relatively safe compared to amphetamines.
b) Armodafinil
- Status: Also approved and listed on the ARTG.
- Indications: Similar to modafinil but with a longer half-life, making it preferable for sustained wakefulness throughout the day.
- Advantages:
- Effective in reducing daytime sleepiness.
- Sometimes chosen for patients who metabolize modafinil too quickly or need longer-lasting coverage.
3. Solriamfetol in Australia Clinical Context
- While Solriamfetol offers a novel mechanism, its absence from the Australian market means modafinil and armodafinil remain the first-line pharmacological therapies for EDS.
- Other advanced treatments, like pitolisant or sodium oxybate, are also not widely available outside of specialist pathways.
4. Summary Table
| Drug | Legal Status in Australia | Access Path | Notes |
|---|---|---|---|
| Solriamfetol (Sunosi) | Not registered (not on ARTG) | Only via Special Access (rare) | Not legally marketed |
| Modafinil | Approved, ARTG-listed | Prescription; PBS-subsidized | Widely available |
| Armodafinil | Approved, ARTG-listed | Prescription | Longer-acting alternative |
5. Final Thoughts
Solriamfetol in Australia is not legally accessible under standard medical channels. While international data highlight its value for OSA- and narcolepsy-related EDS, Australian patients continue to rely primarily on modafinil and armodafinil, both of which are legal, effective, and subsidized for certain conditions. Until regulatory approval is granted, Solriamfetol remains unavailable outside of special exemptions.