Solriamfetol, marketed under the brand name Sunosi, is a wakefulness-promoting agent approved for treating excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea (OSA). While widely available in various countries including the United States and European Union, its legal status of Solriamfetol in the UK has raised questions among patients, healthcare providers, and nootropic enthusiasts.
This article provides a comprehensive overview of Solriamfetol’s legal and regulatory status in the UK, including its prescription classification, import rules, and access pathways.
Is Solriamfetol Legal in the UK?
Yes — But Prescription-Only
Solriamfetol is legal in the UK, but it is classified as a prescription-only medicine (POM). This means that it can only be obtained with a valid prescription issued by a licensed healthcare professional. As of its approval by the European Medicines Agency (EMA), the UK, following Brexit, has maintained regulatory alignment on many medicines, including Solriamfetol.
Regulatory Approval and Licensing
European Medicines Agency (EMA)
Solriamfetol was granted EU marketing authorization in January 2020 under the brand Sunosi, developed by Jazz Pharmaceuticals. Although the UK is no longer a part of the EU, it continues to recognize EMA-approved drugs under specific transitional regulations or seeks separate MHRA (Medicines and Healthcare products Regulatory Agency) approval.
MHRA Status
- Sunosi has been licensed for use in the UK under the post-Brexit regulatory regime.
- It is regulated under the Human Medicines Regulations 2012.
- It is not classified as a controlled substance, which differentiates it from more tightly restricted stimulants.
How Is Solriamfetol Prescribed in the UK?
Indications for Use
Solriamfetol is prescribed for:
- Narcolepsy, with or without cataplexy
- Obstructive Sleep Apnea (to treat excessive daytime sleepiness, not to replace CPAP therapy)
Eligibility
A prescription will generally only be issued by a specialist such as a neurologist or sleep medicine consultant, particularly in NHS Trusts or private sleep clinics.
Dosage Forms
Solriamfetol is available in tablet form in strengths of 75 mg and 150 mg, taken once daily in the morning.
Can You Import Solriamfetol into the UK?
Personal Import Restrictions Apply
Under UK law, importing Solriamfetol without a prescription is not permitted. Even though it is not a controlled drug under the Misuse of Drugs Act 1971, it is still regulated as a POM.
- Personal use imports may be allowed with documentation, such as a valid prescription and doctor’s note.
- UK Border Force may seize unauthorised packages, particularly those from online or overseas pharmacies.
Always consult the MHRA or your local GP before attempting to bring Solriamfetol into the country.
Over-the-Counter and Online Sales
Solriamfetol is not available over the counter in the UK. Buying it from unregulated online pharmacies is both risky and illegal. The MHRA has taken enforcement actions against websites selling unlicensed or counterfeit prescription drugs.
Warning Signs of Grey Online Pharmacies:
- No requirement for prescription
- No verified UK address or contact
- Claims to sell “generic Sunosi” (no legitimate generics are currently authorized)
Comparison with Other Eugeroics in the UK
| Drug | Legal Status in UK | Prescription Required | Controlled Substance |
|---|---|---|---|
| Modafinil | Legal (POM) | Yes | No |
| Armodafinil | Unlicensed | Yes (off-label) | No |
| Solriamfetol | Legal (POM, MHRA-licensed) | Yes | No |
| Pitolisant | Legal (POM) | Yes | No |