ArticleJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2026
Symptom improvement with dosing above 9 g of low-sodium oxybate: effectiveness and safety in participants with narcolepsy in the DUET study.
Article in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05875974 (A Prospective, Open-Label, Single-Arm, Multicenter Study to Evaluate the Effect of Low-Sodium Oxybate Oral Solution), which is not on this map. Not yet cited in PubMed.
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A Prospective, Open-Label, Single-Arm, Multicenter Study to Evaluate the Effect of Low-Sodium Oxybate Oral Solution (XYWAV) on Sleepiness, Polysomnography, and Functional Outcomes in Adult Participants Aged 18 to 75 Years With Idiopathic Hypersomnia or Narcolepsy
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Abstract
purposeEvaluate effectiveness/safety of low-sodium oxybate (LXB; Xywav
methodsJazz DUET (prospective, multiple-cohort, open-label study [NCT05875974]) included screening, 9-day baseline (LXB 9 g/night ["LXB 9 g BL"]), 2-8-week titration, 2-week stable-dose, 9-day end-of-treatment (LXB > 9 g- ≤ 12 g ["optimized LXB > 9 g EOT"]; twice-nightly, first/second max doses = 7.5/4.5 g), and 2-week follow-up. Endpoints included Epworth Sleepiness Scale (ESS), Narcolepsy Severity Scale-clinical trials version (NSS-CT), Patient Global Impression of Severity (PGI-S) and Change (PGI-C), and polysomnography (PSG)-measured respiratory assessments.
resultsForty-eight participants took LXB > 9 g/night (mean ± SD age: 39.2 ± 10.9 years; 62.5% female); 44 (NT1, n = 28; NT2, n = 16) completed the study. Mean ± SD stable-LXB dosage (n = 45) was 11.1 ± 1.0 g/night (most common [43.8%], 12 g/night). From LXB 9 g BL to optimized LXB > 9 g EOT, mean ± SE ESS scores (11.4 ± 0.8 to 8.3 ± 0.9), NSS-CT (NT1) scores (17.3 ± 2.2 to 9.4 ± 2.1), and NSS-2-CT (NT2) scores (9.7 ± 1.7 to 4.3 ± 1.6) improved. Fewer participants rated their disease as severe (61.4% to 29.5%), and most (92.3%) reported their disease improved. AHI (1.8 ± 0.4 to 1.6 ± 0.3), CAI (0.01 ± 0.01 to 0.01 ± 0.00), and mean SpO
conclusionParticipants taking LXB > 9 g/night experienced further improvements in narcolepsy symptoms versus 9 g/night, suggesting some patients may require higher dosages for optimal benefit. No changes in mean respiratory PSG measures were observed. TEAEs align with the known safety profile. Findings support individualized clinical decision-making with higher LXB dosages. CLINICAL
trial registrationTrial name: A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy; URL: https://clinicaltrials.gov/study/NCT05875974 ; ID number: NCT05875974. CURRENT KNOWLEDGE/STUDY RATIONALE: Narcolepsy is a heterogeneous disorder requiring individualized treatment strategies to optimize symptom management. This study fills a critical knowledge gap by evaluating effectiveness and safety of low-sodium oxybate (LXB) dosing regimens higher (> 9-12 g/night) than the recommended dosage (6-9 g/night). STUDY IMPACT: Participants with narcolepsy taking LXB > 9 g/night experienced further overall symptom benefit compared with 9 g/night at baseline, suggesting some patients may require higher dosages to achieve optimal therapeutic benefit. The safety profile, including respiratory safety parameters, was comparable to that observed at 9 g/night. Findings demonstrate that LXB can be utilized at dosages up to 12 g/night to optimize effectiveness, supporting individualized clinical decision-making. Low-sodium oxybate (LXB; Xywav
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