Solriamfetol for treating excessive daytime sleepiness caused by obstructive sleep apnoea

1 Recommendations

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.

Clinical trial evidence shows that solriamfetol added to a primary obstructive sleep apnoea therapy (standard care) reduces excessive daytime sleepiness compared with standard care alone. The evidence does not show a difference in quality of life, but this is uncertain because of the way that quality of life was assessed in the trial. No evidence has been presented on solriamfetol alone, although it is an option in the full marketing authorisation for people who cannot use CPAP.

There are concerns about how the trial data have been modelled to take account of a potential placebo effect in the standard care group, and uncertainty about the assumptions around the doses used in clinical practice. Therefore, the cost-effectiveness estimates for solriamfetol with standard care 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.