Lower-sodium oxybate contains the same active moiety with 92% less sodium. The American Academy of Sleep Medicine strongly recommends sodium oxybate as effective for improving cataplexy and excessive daytime sleepiness in narcolepsy. In a forced preference questionnaire, 85.7% of participants said they preferred lower-sodium oxybate. Only 9.5% of participants reported that making the switch was difficult. Participants in SEGUE were able to maintain concomitant medications, but which medications they took were not reported.Īfter switching and taking lower-sodium oxybate for 6 weeks, 57.1% of participants in SEGUE reported improved narcolepsy and 42.9% reported no change. After 6 weeks, ESS scores were similar (mean change -0.6☒.0, median change 0.0 ). Similarly, in the smaller SEGUE study ( NCT04794491), participants (n=21) had baseline measurements while taking sodium oxybate for2 weeks and then switched to lower-sodium oxybate. Participants could select more than 1 reason and 14.1% selected another reason in addition to these.Ĭoncomitant medications taken by participants in TENOR at baseline including wake-promoting agents (47.1%), amphetamine stimulants (35.3%), selective serotonin/norepinephrine reuptake inhibitors (32.9%), methylphenidate stimulants (9.4%), and other agents (5.9%). Other reasons selected included physician recommendation (47.1%), avoiding current cardiovascular issues (38.8%), avoiding side effects (30.6%), and to improve symptom control (17.6%). Lower-sodium oxybate is approved by the Food and Drug Administration (FDA) and is expected to reduce cardiovascular morbidity in many for whom oxybate is indicated for treatment of narcolepsy.ĭecreases in the proportion of participants with excessive sweating (from 40.5% to 26.6%) and dizziness (27.4% to 13.9%) were seen 1 week after switching to lower-sodium oxybate.Īlmost all participants (92%, n=85) selected "long-term health/lower sodium content)" as a reason for making this switch. Xyrem may only be dispensed to patients enrolled in the Xyrem REMS Program. Food and Drug Administration ( FDA) for both cataplexy and excessive daytime sleepiness in narcolepsy in adult and pediatric patients ages 7 and older. Interim data analysis from the TENOR trial ( NCT04803786) shows people with narcolepsy who switched from sodium oxybate (Xyrem Jazz Pharmaceuticals, Philadelphia, PA) to lower-sodium oxybate (Xywav Jazz Pharmaceuticals) maintained symptomatic relief. Xyrem oral solution, CIII, is the only product approved by the U.S.
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