Sodium Oxybate in Australia

Sodium oxybate is now a TGA-approved medicine in Australia for the treatment of narcolepsy.

On 9 July 2026, a generic brand of sodium oxybate became a TGA-approved medicine in Australia following its inclusion on the Australian Register of Therapeutic Goods (ARTG).

It is important to note that this approval is for narcolepsy only. Sodium oxybate is not approved in Australia for idiopathic hypersomnia. There are currently no medications approved specifically for idiopathic hypersomnia in Australia.

Although sodium oxybate is now TGA approved, it is not currently listed on the Pharmaceutical Benefits Scheme (PBS). This means many people will still need to pay the full cost of treatment.

What is sodium oxybate?

Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB). It is a central nervous system depressant and a highly controlled Schedule 8 medicine.

It is supplied as a liquid solution that is mixed with water and taken by mouth. The formulation currently available in Australia is taken in two doses each night — one at bedtime and another 2½ to 4 hours later.

A once-nightly formulation of sodium oxybate is available in some countries, but this version is not currently available in Australia.

Who can access sodium oxybate in Australia?

Sodium oxybate is approved for people with narcolepsy. Your treating sleep specialist will determine whether it is an appropriate treatment option based on your symptoms, medical history, current medications and individual circumstances.

Although sodium oxybate is not approved for idiopathic hypersomnia, a sleep specialist may prescribe it off-label, via a private script if they believe it is clinically appropriate.

How much does sodium oxybate cost?

As sodium oxybate is not currently PBS listed, the medication is generally paid for in full by the individual unless another funding arrangement is available.

Prices vary between pharmacies and supply arrangements. If you are considering sodium oxybate, ask your pharmacy to confirm the current cost before ordering.

Can sodium oxybate be subsidised through a public hospital?

Some people may be able to access sodium oxybate at a subsidised cost through a public hospital.

To be eligible, you generally need to:

• be a patient of a sleep specialist in a public hospital;

• have tried other appropriate treatment options; and

• be unable to afford the full cost of sodium oxybate.

If your treating specialist is willing to complete the required applications and supporting documentation, many public hospitals can apply for funding through their Medicines Access Program (sometimes called a Compassionate Use, Expanded Access, Cost-Share or Early Access Program).

Hospital funding decisions vary between hospitals and states and territories, so approval cannot be guaranteed.

People living in Western Australia

Unlike other Australian states and territories, sodium oxybate is included in the WA Statewide Medicines Formulary (SMF).

This means eligible people with refractory narcolepsy who are treated through a WA public hospital may be able to access sodium oxybate through the Formulary rather than requiring an individual hospital funding application.

Your treating sleep specialist can advise whether you meet the eligibility criteria.

How do I access sodium oxybate?

If you and your sleep specialist decide that sodium oxybate is an appropriate treatment option, the general process is now much simpler than it was previously.

1. Discuss treatment with your sleep specialist

Your specialist will determine whether sodium oxybate is appropriate for your individual circumstances.

2. State or territory prescribing requirements

Because sodium oxybate remains a Schedule 8 controlled medicine, your doctor may still need to obtain the relevant authority or permit required by your state or territory before prescribing it.

3. Your prescription

Once any required approvals are in place, your doctor can write your prescription.

4. Filling your prescription

Your prescription can be filled through an appropriate hospital or community pharmacy. As sodium oxybate is a specialised medication, it may need to be ordered in.

Your pharmacy will be able to advise current availability, expected delivery time and cost.

Is sodium oxybate the right treatment for me?

This is a decision you should make together with your treating sleep specialist.

Your doctor will consider your symptoms, other medical conditions, current medications and the potential benefits and risks before deciding whether sodium oxybate is appropriate for you.

Feedback on the generic formulation

We have received reports that the generic sodium oxybate formulation may not work in the same way as Xyrem® for some people. Some people have reported a return of symptoms, while others have experienced new or worsening side effects.

These reports may be isolated, but collecting people's experiences will help us understand whether there is a broader issue and provide evidence that can be shared with suppliers, prescribers and regulators.

If you take the generic sodium oxybate formulation and notice any new or worsening side effects, a return of symptoms, or any other differences in how the medication works for you, please first speak with your treating doctor or sleep specialist and then complete our short feedback form. Your feedback will help us determine whether these reports represent isolated experiences or a more widespread issue.