Treatments for Narcolepsy Type 1 in Australia: What's happening and the work behind the scenes
For Australians living with Narcolepsy Type 1 (NT1), access to appropriate treatment has been a longstanding challenge. While new medications have become available overseas, Australians have continued to face limited treatment options, high costs and significant barriers to accessing care.
But there has been important progress in 2026.
Clinical trials investigating new treatments for NT1 are being conducted here in Australia, new medicines are progressing through Australia's regulatory processes, and research is underway to document the experiences and unmet needs of Australians living with NT1 to help improve access to treatment.
Hypersomnolence Australia (HA) has been actively involved in this work. While much of what we do happens behind the scenes, we want our community to understand what is happening, why it matters and how their participation helps us advocate for better treatment and care.
What's happening with NT1 medications in Australia?
Sodium oxybate is now TGA approved
On 9 July 2026, sodium oxybate was finally registered by the Therapeutic Goods Administration (TGA) for the treatment of narcolepsy in Australia.
This was an important development, particularly given the difficulties Australians have historically faced accessing this medication.
However, sodium oxybate is not listed on the Pharmaceutical Benefits Scheme (PBS), which means affordability remains a significant barrier for many people.
Some people may be able to access subsidised treatment through public hospital arrangements, depending on their circumstances and where they live.
We have published a detailed article explaining the approval, costs, prescribing arrangements and possible access pathways.
Read more: Sodium Oxybate in Australia
What about other medications available overseas?
Medications such as pitolisant (Wakix) and solriamfetol (Sunosi) may be accessible in Australia, even though they are not TGA registered or PBS listed.
There are pathways to access unregistered medicines, including the TGA's Special Access Scheme and personal importation.
Medications already registered by the TGA can also be prescribed privately for conditions other than those they were approved to treat. This is known as off-label prescribing, and means treatment options are not limited to medicines specifically approved for NT1.
Just because a medication isn't offered by your doctor doesn't mean it isn't available. Ask your sleep specialist about other treatment options, including those available overseas.
For more information, see the TGA's guidance on accessing unapproved medicines.
Orexin agonists: A major development for NT1
One of the most significant developments in the treatment of central disorders of hypersomnolence has been the emergence of orexin receptor agonists.
Orexin receptor agonists are a new class of medicines that activate the brain's orexin receptors, which play an important role in regulating wakefulness. Although initially developed for NT1, these medicines have also shown promising results in people with IH and NT2, who generally do not have the orexin deficiency associated with NT1. Clinical trials investigating their use in IH and NT2 are ongoing.
Oveporexton (ORZEYFUL / ONZAYFUL), developed by Takeda Pharmaceuticals, is one of these new medicines for NT1.
Following significant international progress, Takeda's application for Australian registration was accepted by the TGA in July 2026. The medicine has been granted orphan drug designation and priority review status.
The proposed Australian indication is for people aged 16 years and older living with NT1.
The Australian TGA application is now under evaluation.
You can follow its progress directly on the TGA website: TGA — ORZEYFUL / ONZAYFUL application under evaluation
What about PBS listing?
TGA registration and PBS listing are separate processes.
TGA registration means a medicine has been approved for supply in Australia, while PBS listing means the government subsidises its cost for people who meet the relevant eligibility criteria. Medicines can also be prescribed for conditions other than those for which they were approved (off-label prescribing). Importantly, work towards PBS reimbursement does not have to wait until the TGA has completed its evaluation.
We understand that work to support Australian reimbursement of oveporexton is already underway alongside the TGA process.
There is not yet a publicly identifiable PBAC application for oveporexton, but you can follow publicly available developments through the PBS Medicine Status Website.
HA remains actively involved in this work and will continue to keep our community informed as it progresses.
The work happening behind the scenes
Getting new medications approved and made affordable in Australia requires more than evidence from clinical trials.
It is also important to demonstrate the experiences of Australians living with NT1, the limitations of currently available treatments, and the impact the disorder has on everyday life.
This year, HA has worked closely with researchers and other stakeholders on projects designed to gather that evidence.
Our involvement has included helping develop research surveys, reviewing questions to ensure they reflect the experiences of people living with narcolepsy, promoting participation and working directly with community members to encourage and assist them to take part.
We have also participated in discussions about the findings and the broader challenges facing Australians living with NT1.
These projects are producing evidence that can inform decisions about treatment access, but their value extends beyond individual medication applications.
The information gathered can also help demonstrate the need for better diagnosis, improved clinical care, education and other measures to address the substantial impact of living with NT1.
This is why HA considers these projects so important.
Why your participation in surveys matters
We regularly ask our community to participate in research, surveys and other projects.
We understand that completing surveys takes time and energy, particularly for people living with disorders that significantly affect wakefulness, concentration and cognitive functioning.
But there is a reason we keep asking.
When decisions are being made about treatments and healthcare, evidence of people's actual experiences matters.
Clinical trials can demonstrate whether a medication works and how safe it is. They cannot, on their own, provide a complete picture of what it is like to live with NT1 in Australia.
They do not necessarily capture the difficulties people experience obtaining a diagnosis, finding knowledgeable clinicians, accessing appropriate treatment, maintaining employment, completing education or managing everyday responsibilities.
This is where community research becomes so valuable.
Every completed survey contributes information that helps researchers and advocates demonstrate what needs to change.
And the more people who participate, the stronger and more representative that evidence can be.
We know that people living with narcolepsy have been waiting a long time for better treatment options. Participating in these projects is one practical way to help improve the evidence available to those making decisions about treatment and care.
When HA asks you to participate in research, there is a reason. We are not asking simply to collect responses. We are working to ensure the experiences of our community are documented and taken seriously.
Access to medication is only part of the solution
While the prospect of new treatments becoming available in Australia is encouraging, medication access alone will not resolve all the challenges faced by people living with NT1.
People also need timely and accurate diagnosis, knowledgeable sleep specialists, appropriate treatment and ongoing care that reflects the realities of living with narcolepsy.
For many years, central disorders of hypersomnolence received little clinical or research attention in Australia, and in the case of idiopathic hypersomnia, there has been none.
The recent increase in activity is welcome, but it should not be mistaken for a longstanding commitment to improving outcomes for people living with these disorders.
HA has spent more than a decade advocating for greater recognition, better clinical understanding and more meaningful engagement with people living with these disorders.
We want Australian sleep specialists to understand more than the diagnostic criteria and the mechanisms of medications. We want them to understand the people they are treating.
That includes the impact of NT1 on everyday functioning, education, employment, relationships and quality of life, as well as the challenges people encounter within the healthcare system.
Improving education for Australian sleep specialists is an important part of this work.
HA is continuing to engage with stakeholders and pursue opportunities to improve clinical understanding and the standard of care available to people living with narcolepsy.
New medications represent important progress. Ensuring people receive appropriate care alongside those treatments is just as important.
Hypersomnolence Australia is working for people living with narcolepsy
Our work includes collaborating with researchers, engaging with pharmaceutical companies and other stakeholders, contributing lived-experience expertise, encouraging community participation in research and advocating for improvements in treatment and care.
Much of this work is not immediately visible.
People may see a survey shared on social media or an announcement about a new medication without realising the work involved in bringing these opportunities to the Australian community.
HA receives no funding and charges no membership fees. Our work is undertaken voluntarily, driven by our commitment to improving outcomes for people living with these disorders.
We are proud of the role we have played in helping ensure the experiences of Australians living with narcolepsy are represented in important research and discussions about treatment access.
And our work will continue well beyond the registration or PBS listing of any individual medication.
Our goal is not simply to see new treatments become available in Australia. It is to see Australians living with narcolepsy receive the knowledgeable, appropriate care and treatment they deserve.
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