NICE has issued a positive Final Appraisal Document (FAD) recommending solriamfetol (Sunosi) for adults with excessive daytime sleepiness (EDS) caused by narcolepsy.

Solriamfetol is recommended as an option for treating EDS in adults with narcolepsy with or without cataplexy. This is only if modafinil and either dexamfetamine or methylphenidate (methylphenidate is not licensed for the treatment of EDS due to narcolepsy in the UK) have not worked well enough or are not suitable.

EDS is a defining clinical symptom of narcolepsy and is usually the first symptom to appear. It can interfere with every aspect of a person’s life including their physical and mental health, relationships, employment, career, daily activities, social interactions and family life.

Matt O’Neill, chair of trustees at Narcolepsy UK, said: “This decision increases treatment options for people with narcolepsy, creating more opportunity for them to access effective treatment sooner. This is a key aim of Narcolepsy UK’s Charter as access to effective treatment can dramatically improve multiple aspects of people's lives including their education, working, family and social life.

"We welcome NICE’s decision and the committee’s recognition of the need for pragmatism when faced with limited evidence with which to compare the cost-effectiveness of treatments for rare diseases such as narcolepsy.”

A much-needed additional treatment option for EDS

Once-daily solriamfetol is indicated to improve wakefulness and reduce EDS in adult patients with narcolepsy with the approved doses of 75mg or 150mg daily. The NICE recommendation for solriamfetol is based on data from three studies in the Treatment of Obstructive sleep apnoea and Narcolepsy Excessive Sleepiness (TONES) clinical trial programme.

The clinical trial programme for solriamfetol evaluated over 900 adults with EDS associated with narcolepsy or obstructive sleep apnoea (OSA). Solriamfetol demonstrated its superiority relative to placebo and was shown to maintain its effect after six months of use.

Dr Paul Reading, consultant neurologist at South Tees National Health Service (NHS) Foundation Trust, said: “NICE’s recommendation to offer routine NHS access to solriamfetol gives clinicians a much-needed additional treatment option in the management of EDS in narcolepsy for adult patients. Solriamfetol is a once-daily, effective therapy with an interesting mechanism of action as a dual-acting dopamine and noradrenaline reuptake inhibitor."