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Solriamfetol for treating excessive daytime sleepiness caused by narcolepsy

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1 Recommendations

1.1 Solriamfetol is not recommended, within its marketing authorisation, for treating excessive daytime sleepiness in adults with narcolepsy with or without cataplexy.

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 narcolepsy is usually first treated with modafinil then dexamfetamine or methylphenidate. There is limited availability of other treatments such as sodium oxybate and pitolisant in clinics across England, which means they cannot be considered routine practice.

Clinical trial evidence shows that solriamfetol reduces excessive daytime sleepiness compared with placebo. It does not show a difference in quality of life but this is not certain because of the way that quality of life was assessed in the trial. There are no data comparing solriamfetol with dexamfetamine or methylphenidate. Therefore, the clinical effectiveness of solriamfetol compared with dexamfetamine or methylphenidate is uncertain.

There are also concerns about how the treatment pathway and quality of life are modelled, and uncertainty about the assumptions around stopping treatment and dose. Therefore the cost-effectiveness estimates for solriamfetol compared with dexamfetamine or methylphenidate are uncertain. They are also very likely to be higher than what NICE normally considers an acceptable use of NHS resources. So solriamfetol is not recommended.