This analysis of treatment-emergent adverse events during the open-label treatment titration and optimization, stable dose, and extension periods of a phase 3 study in participants with narcolepsy found that the safety and tolerability profile of low-sodium oxybate was generally consistent with the known safety profile of sodium oxybate.

The incidence of treatment-emergent adverse events declined over time across the duration of the study, and most events were of short duration.

The most common treatment-emergent adverse events reported with longer-term low-sodium oxybate use were headache, dizziness, and nasopharyngitis.

The most common treatment-emergent adverse events leading to discontinuation during the main study period were cataplexy, headache, nausea, and psychiatric disorders; of these, only headache was common during the open-label extension.