Logan Schneider, MD, Adjunct Clinical Associate Professor of Psychiatry and Behavioral Sciences at Stanford University, discusses the DUET clinical trial of Xywav (low sodium oxybate) in patients with narcolepsy.
Narcolepsy is a chronic neurological disorder characterized by an inability of the brain to control sleep-wake cycles. Patients with narcolepsy typically enter REM sleep more quickly, causing the boundaries between wakefulness and sleep to blur. This causes fragmented sleep at night as well as muscle weakness and dream activity while awake. Common symptoms include excessive daytime sleepiness, cataplexy, sleep paralysis, and hallucinations.
At the American Academy of Neurology (AAN) 2026 Annual Meeting, data was presented on the impact of low-sodium oxybate dosages greater than 9 g/night on cognitive complaints, functional impairments, work productivity, and symptom severity in participants with narcolepsy who may benefit from higher LXB dosages.
The DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment), a prospective, open-label study (NCT05875974), evaluated the safety and efficacy of low-sodium oxybate in narcolepsy or idiopathic hypersomnia.
A total of 48 patients were enrolled and treated with low-sodium oxybate greater than 9g. Total low-sodium oxybate dosage at stable-dose period (n=45) was 11.1 ± 1.0 g/night. Patient Global Impression of Severity endorsement of ‘severe’ overall disease was 61.4% (9g) versus 29.5% (greater than 9g), with 92.3% of participants reporting overall disease improvement on Patient Global Impression of Change. Mean British Columbia Cognitive Complaints Inventory total scores decreased from 6.9 ± 0.6 on 9g to 5.1 ± 0.7 on greater than 9g, with fewer participants reporting moderate-to-severe cognitive complaints (34.1% to 18.2%).
Mean Functional Outcomes of Sleep Questionnaire-10 total scores in the 9g vs greater than 9g cohorts were 13.6 ± 0.6/14.8 ± 0.6. Work Productivity and Activity Impairment scores also showed trends of improvement in the greater than 9 cohort.
Treatment-emergent adverse events were consistent with the known low-sodium oxybate safety profile.
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To learn more about narcolepsy and other rare neurological conditions, visit https://checkrare.com/diseases/neurology-nervous-system-diseases/