Symptom improvement with dosing above 9 g of low-sodium oxybate: effectiveness and safety in participants with narcolepsy in the DUET study.
Jerald H Simmons, Logan D Schneider, Chad M Ruoff et al.
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In 30 seconds
This prospective, multicohort, open-label study evaluated effectiveness and safety of low-sodium oxybate (LXB) doses above 9 g/night in participants with narcolepsy type 1 or 2 who were already taking 9 g/night. After dose titration, 48 participants took doses above 9 g/night and 44 completed the study. From baseline at 9 g/night to end of treatment at an optimized higher dose, mean Epworth Sleepiness Scale scores decreased from 11.4 ± 0.8 to 8.3 ± 0.9. Respiratory polysomnography measures remained stable, and common treatment-emergent adverse events included nausea, vomiting, and headache.
Key findings
- Mean ESS scores decreased from 11.4 ± 0.8 at 9 g/night to 8.3 ± 0.9 at optimized doses above 9 g/night.
- Narcolepsy severity scores improved: NT1 NSS-CT scores changed from 17.3 ± 2.2 to 9.4 ± 2.1, and NT2 NSS-2-CT scores from 9.7 ± 1.7 to 4.3 ± 1.6.
- The proportion rating disease as severe fell from 61.4% to 29.5%; 92.3% reported improvement.
- Mean AHI, CAI, and SpO₂ remained stable; nausea and vomiting each occurred in 12.5%, and headache in 10.4%.
Why it matters
The findings suggest that some people with narcolepsy may experience additional symptom improvement when LXB is titrated above 9 g/night, while mean respiratory measures did not change in this study. This provides clinical information about higher-dose use in selected participants and supports considering symptom response and tolerability when individualizing dosing, without establishing comparative efficacy or safety against a control group.
What to keep in mind
The study was open-label and lacked a concurrent control group; the treatment periods and end-of-treatment assessment were short.