Abstract Details

Title Effects of Oxybate on Sleep, Sleep Architecture, and Disrupted Nighttime Sleep

Topic Sleep

Presentation(s) P10 - Poster Session 10 (11:45 AM-12:45 PM)

Poster/Presentation
Number 9-006

Objective Review the scientific literature regarding the impact of oxybate dose and regimen on sleep quality, sleep architecture, and disrupted nighttime sleep (DNS) in patients with narcolepsy.

Background Sleep disturbances in narcolepsy encompass self-reported sleep quality, sleep architecture, and DNS. DNS is associated with frequent sleep stage shifts and awakenings/arousals on polysomnography. Sodium oxybate (SXB; Xyrem^®), dosed twice nightly, is approved to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. Once-nightly sodium oxybate (ON-SXB; Lumryz™) and low-sodium oxybate (Xywav^®) have been approved for the same indication. Both SXB and ON-SXB improve DNS. Therefore, a review of oxybate’s impact on sleep disturbances in patients with narcolepsy is timely.

Design/Methods PubMed was searched for articles on oxybate, narcolepsy, and DNS. Key data from 5 studies are presented.

Results Participants in study 1 (SXB, ≥16 years) showed significant improvements in self-reported sleep quality, increases in N3, and decreases in REM and sleep stage shifts/hour. Participants in study 2 (SXB, ≥18 years) demonstrated significantly improved sleep quality relative to placebo, increases in N3, and decreases in REM and sleep stage shifts. Participants in study 3 (ON-SXB, ≥16 years) showed significantly improved sleep quality; increases in N3; and decreases in REM, N1, arousals, and sleep stage shifts. In study 4 (open-label, SXB), participants demonstrated improved sleep quality, significantly increased N3 and decreased REM in the second half of the night, and decreased awakenings. In study 5 (SXB, pediatric), participants (SXB-naive at study entry) showed decreases in N1%, REM%, and arousals and increases in N3%.

Conclusions A clinical data review shows that oxybate, independent of once- or twice-nightly dosing, is effective in improving sleep, measures of sleep architecture, and DNS in participants with narcolepsy.

Authors/Disclosures
Jed Black, MD (Jazz Pharmaceuticals) PRESENTER	Jed Black, MD has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Jed Black, MD has stock in Jazz Pharmaceuticals. Jed Black, MD has stock in .
Thomas Roth, PhD (Henry Ford Hospital)	Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Roth has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Avadel. Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz.
Yves Dauvilliers, MD, PhD (Hopital Gui De Chaulliac)	Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for idorsia. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for JAZZ. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avadel. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alkermes. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Centessa. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bioprojet. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Harmony Bioscience.
Richard K. Bogan, MD (SleepMed)	Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz Pharmaceutical . Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome . Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Harmony. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Jazz. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Axsome. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Jazz. The institution of Dr. Bogan has received research support from Jazz Pharmaceuticals. The institution of Dr. Bogan has received research support from Harmony . The institution of Dr. Bogan has received research support from Eisai. The institution of Dr. Bogan has received research support from Avadel. The institution of Dr. Bogan has received research support from Takeda. The institution of Dr. Bogan has received research support from Suven. The institution of Dr. Bogan has received research support from Axsome. The institution of Dr. Bogan has received research support from Merck. The institution of Dr. Bogan has received research support from Liva Nova. The institution of Dr. Bogan has received research support from Nyxoah. Dr. Bogan has received research support from Bayer. Dr. Bogan has received intellectual property interests from a discovery or technology relating to health care.
Giuseppe Plazzi, MD (University di Bologna)	The institution of Dr. Plazzi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TAKEDA. The institution of Dr. Plazzi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BIOPROJET. The institution of Dr. Plazzi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for JAZZ. The institution of Dr. Plazzi has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for OREXIA. The institution of Dr. Plazzi has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for OREXIA/CENTESSA.

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