Once-Nightly Sodium Oxybate Highly Preferred in Clinical Study

According to the questionnaires participants took in the RESTORE study (NCT04451668) for sodium oxybate (FT218; Avadel Pharmaceuticals, Philadelphia, PA) to treat narcolepsy, once-nightly vs twice-nightly regimens were highly preferred. 

Over half the participants (n=38/60) (63%) reported forgetting their second-nightly dose at least once within the preceding 3 months. For 84% of those individuals, narcolepsy symptoms were worse the following day.

A delay in taking the second dose of more than the recommended 4 hours was reported by 24 (40%). Almost half (42%) of those participants felt somewhat, quite a bit, or extremely groggy or unsteady, when they woke up in the morning.

Most of the participants (73%) (44/60) stated that taking a second dose during the night and having to wake up to take the dose was inconvenient. The majority (90%) of participants were unable to go back to sleep and proceeded to get out of bed. From that majority, 3 reported falling and 2 reported injuries. Due to having to wake up from sleep during the night, 20% had anxiety concerning the 2nd dose, and 23% needed assistance to be woken.

“Twice-nightly oxybates for narcolepsy require a challenging dosing regimen that disrupts nighttime sleep. The results from the nocturnal adverse event questionnaire illustrate the burden that the second dose places on some patients, who already struggle with getting a full night of refreshing sleep,” said Asim Roy, MD, presenting author and medical director of the Ohio Sleep Medicine Institute. “In my experience with patients in my practice, a once-at-bedtime option like FT218 would ease this burden and has the potential to be a major advance for the entire narcolepsy community.”
 
During an interim data cutoff, the 35 participants switched from twice-nightly to once-nightly sodium oxybate and completed the preference questionnaires 3 months after switching. Responses specified 94.3% (33/35) preferred the once-nightly compared with twice-nightly dosing regimen. 

The data for the study were presented at the 2022 American Academy of Neurology Annual (AAN) Meeting, being held virtually from April 24-26.