One of the most frequently reported symptoms of narcolepsy is disturbed nocturnal sleep/disrupted nighttime sleep, characterized by a disruption in sleep architecture and sleep continuity. FT218 is an investigational, novel, once-nightly formulation of sodium oxybate.

In this randomized controlled clinical trial, both subjective and objective measures of disrupted nighttime sleep were significantly improved for the once-nightly formulation of sodium oxybate at 6, 7.5, and 9 g vs placebo.

The results from this trial support the use of a once-nightly formulation of sodium oxybate for the nocturnal symptoms of narcolepsy, as well as an improvement in patients’ perception of their sleep, including in those taking concomitant stimulants and/or wake-promoting agents.