1.1 Solriamfetol is not recommended, within its marketing authorisation, to improve wakefulness and reduce excessive daytime sleepiness in adults with obstructive sleep apnoea whose sleepiness has not been satisfactorily treated by primary obstructive sleep apnoea therapy, such as continuous positive airway pressure (CPAP).
1.2 This recommendation is not intended to affect treatment with solriamfetol that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Excessive daytime sleepiness caused by obstructive sleep apnoea is usually first treated with a primary obstructive sleep apnoea therapy such as CPAP (standard care).
Clinical trial evidence shows that solriamfetol alone and when added to standard care reduces excessive daytime sleepiness compared with standard care alone.
The trial evidence does not show an improvement in quality of life. This may be because of how it was measured in the trials. It is likely that reducing excessive daytime sleepiness translates into improved quality of life, but it is uncertain by how much.
There are also concerns about how the trial data has been used in the economic model. Therefore, the cost-effectiveness estimates for solriamfetol compared with standard care alone are uncertain. They are also likely to be higher than what NICE normally considers an acceptable use of NHS resources. So, solriamfetol is not recommended.