Sodium Oxybate-Reach (sodium oxybate)
Sodium Oxybate-Reach is approved for the treatment of narcolepsy in adults, adolescents and children from the age of 7 years. Sodium Oxybate-Reach contains the active ingredient sodium oxybate.
Sodium Oxybate-Reach is used to treat narcolepsy in adults, adolescents and children from the age of 7 years.
Narcolepsy is a chronic (long term) sleep disorder. The symptoms of narcolepsy include:
- excessive daytime sleepiness (also known as EDS)
- attacks of sleep during normal waking hours
- cataplexy (sudden muscle weakness or paralysis without losing consciousness, in response to sudden emotional reactions)
- sleep paralysis
- hallucinations
- poor sleep.
The active ingredient in Sodium Oxybate-Reach is sodium oxybate, a sodium (salt) of gamma-hydroxybutyrate (GHB). GHB is a chemical substance produced naturally in the body that affects brain activity. It is derived from the neurotransmitter gamma-aminobutyric acid (GABA).
Sodium oxybate is a central nervous system depressant, meaning it slows down activity in the brain.
The exact way sodium oxybate produces an effect in narcolepsy is not fully understood. It is thought to promote deep sleep (slow ‘delta’ wave sleep) and consolidate night-time sleep.
The application to register Sodium Oxybate-Reach was based on medical literature reports submitted by the sponsor company.
Key findings from the medical literature
Effectiveness in treating cataplexy in adults with narcolepsy
- Clinical trials showed that treatment with sodium oxybate reduced the number of cataplexy attacks compared with placebo (a treatment with no active medicine).
- Nightly doses of 6 g and 9 g sodium oxybate reduced the number of cataplexy attacks.
- Available evidence suggests that the benefits of sodium oxybate for cataplexy may be maintained over several years.
Effectiveness in treating excessive daytime sleepiness in adults with narcolepsy
- Clinical trials showed that sodium oxybate improved excessive daytime sleepiness compared with placebo.
- In a clinical trial with 228 adult patients, sodium oxybate at nightly doses of 6 g and
9 g improved excessive daytime sleepiness compared with placebo. - In another clinical trial with 222 adults who were taking modafinil (a medicine used to reduce ESD), sodium oxybate, either alone or in combination with modafinil, improved wakefulness.
Effectiveness in treating cataplexy and excessive daytime sleepiness in adolescents and children from the age of 7 years
A clinical trial including 104 children and adolescents (aged 7 to 16 years) with narcolepsy showed that sodium oxybate was effective in treating both cataplexy and EDS.
- Children and adolescents who stopped sodium oxybate treatment and switched to the placebo experienced an increase in weekly cataplexy attacks.
- Stopping sodium oxybate treatment was associated with worsening severity of cataplexy and narcolepsy compared with those who continued treatment.
- Children and adolescents who stopped sodium oxybate treatment also experienced increased daytime sleepiness compared with those who continued treatment.
Adverse events
- The frequency of adverse events (side effects or unexpected outcomes) increased with higher doses of sodium oxybate.
- The most commonly reported adverse events were dizziness, nausea, and headache, all occurring in 10% to 20% of patients.
- For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Sodium Oxybate-Reach and the medicine can be registered in Australia.
More detailed information on why the TGA approved Sodium Oxybate-Reach will be published in the upcoming Australian Public Assessment Report (AusPAR).
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
Australian CMIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
32The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
Australian PIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.
Treatment with sodium oxybate should be initiated by and remain under the guidance of a physician experienced in the treatment of sleep disorders.
Due to its physiological effects, sodium oxybate has the potential to be misused and is consequently scheduled as a controlled substance in countries where it is approved for therapeutic use.
As part of the approval process for Sodium Oxybate-Reach, the sponsor company has put in place several safety measures. These include education of healthcare professionals and patients, strict control of distribution, non-interventional post-marketing surveillance, and a boxed warning in the PI relating to ‘Central Nervous System depression’ and ‘Abuse and misuse’.