Low-Sodium Oxybate Improves Excessive Sleepiness Long-term

Researchers, led by Anne Marie Morse, DO, evaluated the safety and efficacy of low-sodium oxybate (LXB) in patients with idiopathic hypersomnia who continued in the open-label extension (OLE) period of a phase 3, randomized clinical trial. In the main study’s treatment period, LXB was shown to meaningfully improve symptoms of hypersomnia and quality-of-life and functioning measures.

Dr. Morse and colleagues reported the safety and efficacy profiles of LXB improved or maintained during the 6-month OLE period, providing support for the use of LXB as an effective long-term treatment for patients with idiopathic hypersomnia. The study’s findings were presented in the Journal of Clinical Sleep Medicine.

Hypersomnia Improved Long-term With Low-Sodium Oxybate

The primary end points were Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS), Patient Global Impression of Change, Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) scores and treatment-emergent adverse events (TEAEs).

A total of 106 patients with a mean age of 41.0 ± 13.8 years (female, 71%; White, 83%) were included in the 6-month OLE period.

According to the researchers, both mean ESS and IHSS total scores improved from baseline to week 2 and to the end of the treatment extension period:

The median paired differences from week 2 to end of extension were −1.0 (range, −20 to 7; nominal P=.012) for ESS and −1.0 (range, −31 to 19; nominal P=.086).

The proportion of patients who reported a rating of “very much improved” increased from 36.7% at week 2 to 53.8% after the extension period ended. Additionally, authors noted FOSQ-10 and WPAI:SHP outcomes did not change and the incidence of newly reported TEAEs decreased during the treatment extension period.

“Efficacy and safety of LXB were maintained or improved during the 6-month OLE,” Dr. Morse summarized, “supporting long-term treatment with LXB in adults with idiopathic hypersomnia.”

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