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Plain Language Summary of Publication
28 March 2025

How once-nightly sodium oxybate is processed in the body in healthy volunteers: a plain language summary

Authors: Richard Bogan, Michael J Thorpy, Sarah Berkowitz, and Jennifer GudemanAuthor Info & Affiliations
Volume 14, Number 5
https://doi.org/10.57264/cer-2024-0243
PDF

Abstract

What is this summary about?

This is a plain language summary of an article originally published in the journal Sleep Medicine. Narcolepsy is a sleep condition in which people have periods of extreme sleepiness during the day. People with narcolepsy may also have symptoms of muscle weakness (cataplexy); seeing, hearing, smelling, tasting, or feeling something that seems real but isn't actually there before falling asleep or while waking up (hallucinations); an inability to move before falling asleep or while waking up (sleep paralysis); and poor sleep at night.
Sodium oxybate (SXB for short) has been used to treat narcolepsy for over 20 years. For more than 20 years, the only available form of SXB needed to be taken twice each night. Twice-nightly SXB (TN-SXB) requires people to take the first dose at bedtime. Most people fall asleep within 5 to 15 minutes after the first dose. Patients then need to wake up and take the second dose of TN-SXB 2.5 to 4 hours later, which is when most of the medicine has left the body.
The United States Food and Drug Administration (also called FDA) approved a once-nightly form of SXB called LUMRYZ™ (sodium oxybate for extended-release oral suspension; ON-SXB for short) in May 2023. ON-SXB treats excessive daytime sleepiness and muscle weakness, also known as cataplexy. People with narcolepsy who take ON-SXB only need to take 1 dose at bedtime.
This summary describes a study that looked at how ON-SXB enters, travels through, and exits the body of healthy volunteers (people without narcolepsy). The study measured the amount of SXB in the blood after taking SXB in 2 different ways: as a once-nightly version and as a twice-nightly version. Looking at the amount of ON-SXB and TN-SXB in the blood at different time points helps researchers see if people who take the 2 medicines, with different dosing, have the same amount of drug in the body overnight.

What were the results?

Overall, the study found that healthy volunteers had the same amount of SXB in their bodies after taking ON-SXB as they did after taking TN-SXB. When they took the same amounts of ON-SXB and TN-SXB, the SXB stayed in their bodies for similar amounts of time. The highest amount and the total amount of SXB in the participants' blood were similar with ON-SXB and TN-SXB. The amount of SXB in the participants' blood 8 hours after taking the medicine was significantly lower with ON-SXB than with TN-SXB. This means that people taking ON-SXB will have less medication in their blood when they wake up the next morning and may be less groggy.

What do the results mean?

The results mean that if people with narcolepsy take the same dose amount of ON-SXB or TN-SXB, their bodies will receive the same amount of SXB in their blood. ON-SXB provides an option for people with narcolepsy to take their medicine once at bedtime without the need for a middle-of-the-night dose, which can improve quality of life.
This is an abstract of the Plain Language Summary of Publication article.
To read the full Plain Language Summary of this article, click here to view the PDF.
Link to original articles here

Acknowledgments

The authors thank the people who took part in the study, their families, and the study team. They acknowledge the people who participated in this study for their valuable contribution to science and medicine advancement.

Financial disclosure

Avadel Pharmaceuticals funded the study and provided the medication. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

R Bogan is a shareholder in WaterMark Medical and Healthy Humming, LLC; serves on the board of directors for WaterMark Medical; is a consultant for Jazz Pharmaceuticals, Takeda Pharmaceutical Co., Avadel Pharmaceuticals, and Oventus; has received industry-funded research from Avadel Pharmaceuticals, BresoTec, Bayer, Idorsia, Suven Life Sciences Ltd., Jazz Pharmaceuticals, Balance, Vanda, Merck & Co., Eisai, Philips, FRESCA Medical, Takeda Pharmaceutical Co., LivaNova, Roche, and Sommetrics; and has served on speakers bureaus for Jazz Pharmaceuticals, Eisai, and Harmony Biosciences. M Thorpy has served as a consultant or on advisory boards for Axsome Therapeutics, Balance Therapeutics, Eisai, Avadel Pharmaceuticals, Harmony Biosciences, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences Ltd., and Takeda Pharmaceutical Co. S Berkowitz is a person with narcolepsy who has personal experience with both ON-SXB and TN-SXB and has received compensation from Avadel Pharmaceuticals as a LUMRYZ™ ambassador. J Gudeman is an employee of Avadel Pharmaceuticals. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing disclosure

Medical writing support was provided by Makaila Wallin, PharmD, from The Curry Rockefeller Group, LLC, a Citrus Health Group, Inc., company (IL, USA), and was funded by Avadel Pharmaceuticals (MO, USA).

Open access

This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/
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