Effects of sodium oxybate: A Synthesis of Findings from 23 Studies

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Original Abstract of the Article

Major research findings

Sodium oxybate has been recognized as a gold standard for the treatment of disrupted nighttime sleep due to narcolepsy. 5 A novel extended-release, once-nightly sodium oxybate formulation (ON-SXB; FT218) is under US Food and Drug Administration review for the treatment of adults with narcolepsy. 5 Sodium oxybate has been shown to improve sleep architecture in patients with narcolepsy, resulting in significant improvements in daytime functioning. 14 Sodium oxybate has also been shown to be effective in reducing the frequency of cataplexy, a symptom of narcolepsy. 2 The long-term efficacy and safety of sodium oxybate have been demonstrated in both adults and children with narcolepsy. 3 20 Sodium oxybate has also been shown to partially normalize the skin temperature profile in patients with narcolepsy. 17 The effects of sodium oxybate on the brain's functional network connectivity are also being investigated. 9 Sodium oxybate has been shown to be effective in treating idiopathic hypersomnia, a sleep disorder characterized by excessive daytime sleepiness. 15

Benefits and Risks

Benefit summary

Sodium oxybate is a medication that can be helpful for people with narcolepsy. It can improve sleep quality, reduce daytime sleepiness and fatigue, and decrease the frequency of cataplexy attacks. 14 2 18 It can also improve overall functioning during the day. 15

Risk summary

Sodium oxybate can cause side effects such as drowsiness, nausea, vomiting, dizziness, and headaches. 20 7 It can also be addictive and may lead to abuse. 10 7 It is important to take sodium oxybate as directed by your doctor. 23 Sodium oxybate can be dangerous if taken with alcohol. 1 7

Comparison between studies

Commonalities between studies

Many studies have shown that sodium oxybate is an effective treatment for narcolepsy, improving sleep quality, reducing daytime sleepiness, and decreasing cataplexy frequency. 14 5 2 18 16 15

Differences between studies

While sodium oxybate has been shown to be effective for both adults and children with narcolepsy, the specific side effects and effectiveness may vary between individuals. 20 3 18 Sodium oxybate has also been shown to partially normalize the skin temperature profile in patients with narcolepsy. 17 However, this effect has not been confirmed in all studies. Additionally, the effects of sodium oxybate on brain functional network connectivity have been investigated, with some studies suggesting that it may be associated with changes in GABA levels in the anterior cingulate cortex. 9 However, this effect is not fully understood and requires further investigation. 8 22 12

Consistency and contradictions in results

While many studies demonstrate the efficacy of sodium oxybate in treating narcolepsy, the effectiveness and side effects may differ based on individual patient responses. 20 3 18 7 Additionally, the potential for addiction and abuse, as well as the interaction with alcohol, should be carefully considered. 10 1 7 22 8 12

Cautions for real-world applications

Sodium oxybate is a powerful medication that can be effective for treating narcolepsy, but it also has risks. 20 7 10 1 7 It is important to discuss the benefits and risks of sodium oxybate with your doctor before taking it. 23 6

Limitations of current research

The long-term effects of sodium oxybate are still being studied. 20 7 3 Sodium oxybate should not be used by pregnant women or women who are breastfeeding. 20 7 The mechanisms by which sodium oxybate exerts its effects on sleep and wakefulness are not fully understood. 9

Future research directions

More research is needed to investigate the long-term effects of sodium oxybate. 20 7 3 6 21 Research is also needed to develop strategies to reduce the risks of side effects, addiction, and abuse associated with sodium oxybate. 10 1 7 6

Conclusion

Sodium oxybate can be a valuable treatment for narcolepsy, improving sleep quality, reducing daytime sleepiness, and decreasing cataplexy frequency. 14 5 2 18 16 15 However, it is important to be aware of the potential side effects and risks associated with the drug, and to discuss them with your doctor. 20 7 10 1 7 Sodium oxybate is a powerful medication and should be used with caution and under the guidance of a healthcare professional. 23

Literature analysis of 23 papers
Positive Content
19
Neutral Content
2
Negative Content
2
Article Type
7
0
1
0
22
1.

Pharmacodynamic interactions of a solid formulation of sodium oxybate and ethanol in healthy volunteers.

Author: ProssNathalie, PatatAlain, VivetPhilippe, BidautMichelle, FauchouxNicolas

Cognitive impairment
Sedation

Sodium oxybate (SO) and alcohol have distinct adverse effect profiles. The objective effects of SMO.IR were much less marked than those of alcohol. No deleterious interaction was observed.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Changes in Cataplexy Frequency in a Clinical Trial of Lower-Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications.

Author: DauvilliersYves, ŠonkaKarel, BoganRichard K, PartinenMarkku, Del Rio VillegasRafael, Foldvary-SchaeferNancy, SkowronskiRoman, ChenAbby, BlackJed, SkobierandaFranck, ThorpyMichael J

Improved cataplexy
Reduced sodium

Lower-sodium oxybate (LXB) was found to effectively improve cataplexy and excessive daytime sleepiness in individuals with narcolepsy. This study further analyzes data from a previous trial exploring the clinical course and feasibility of transitioning from other anticataplectics to LXB monotherapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Long-term efficacy and safety of low-sodium oxybate in an open-label extension period of a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia.

Author: MorseAnne Marie, DauvilliersYves, ArnulfIsabelle, ThorpyMichael J, Foldvary-SchaeferNancy, ChandlerPatricia, ChenAbby, HickeyLuke, BlackJed, BoganRichard K

Improved quality of life
Improved sleepiness
Adverse events

Low-sodium oxybate maintained or improved efficacy and safety in patients with idiopathic hypersomnia during a 6-month open-label extension period. This supports long-term treatment with low-sodium oxybate for this condition.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Effect of FT218, a Once-Nightly Sodium Oxybate Formulation, on Disrupted Nighttime Sleep in Patients with Narcolepsy: Results from the Randomized Phase III REST-ON Trial.

Author: RothThomas, DauvilliersYves, ThorpyMichael J, KushidaClete, CorserBruce C, BoganRichard, RosenbergRussell, DubowJordan, SeidenDavid

Narcolepsy treatment
Once-nightly dosing

Sodium oxybate is the gold standard for narcolepsy-related sleep disruption. Its short half-life requires twice-nightly dosing, leading to inconvenience. A novel extended-release, once-nightly sodium oxybate formulation (ON-SXB; FT218) is under review for narcolepsy treatment, offering potential convenience and improved adherence for patients.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Subacute changes in brain functional network connectivity after nocturnal sodium oxybate intake are associated with anterior cingulate GABA.

Author: BavatoFrancesco, EspositoFabrizio, DornbiererDario A, ZölchNiklaus, QuednowBoris B, StaempfliPhilipp, LandoltHans-Peter, SeifritzErich, BoschOliver G

Sleep promotion

Sodium oxybate (GHB) was found to increase resting-state functional connectivity (rsFC) between the salience network (SN) and the right central executive network (rCEN) in healthy males. This increase in rsFC was associated with changes in GABA levels in the anterior cingulate cortex (ACC). These findings suggest a possible neurobiological signature for the wake-promoting effects of GHB.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Cognitive Impairment Following Clinical or Recreational Use of Gammahydroxybutyric Acid (GHB): A Systematic Review.

Author: AmsterdamJan Van, BruntTibor M, PereiraFilipa R, CrunelleCleo L, BrinkWim Van Den

Alcohol Relapse Prevention
Alcohol Withdrawal Treatment
Cataplexy Treatment
Narcolepsy Treatment
Dependence Potential
Neurotoxicity

This paper systematically reviews the potential cognitive impairments associated with clinical and recreational use of GHB (gamma-hydroxybutyric acid).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

11.

The discriminative stimulus effects of baclofen and gamma hydroxybutyrate in C57BL/6J mice.

Author: WilkersonJenny L, HiranitaTakato, KoekWouter, McMahonLance R

GABA agonism

Baclofen and γ-hydroxybutyrate (GHB) have distinct pharmacological activities despite sharing GABA<sub>B</sub> receptor agonism. This study used discriminative stimulus assays in mice to assess their effects and the role of GABA<sub>B</sub> receptors.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

12.

Effects of intraoperative sodium oxybate infusion on post-operative sleep quality in patients undergoing gynecological laparoscopic surgery: A randomized clinical trial.

Author: CuiMeiying, XingTianyi, ZhaoAnqi, ZhengLanlan, ZhangXinping, XueHang, WuZiyi, WangFang, ZhaoPing

Improved sleep quality

This study investigates the effects of intraoperative intravenous sodium oxybate infusion on post-operative sleep quality in patients undergoing gynecological laparoscopic surgery.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

Prevention of Lipotoxicity in Pancreatic Islets with Gammahydroxybutyrate.

Author: YungJustin Hou Ming, YeungLucy Shu Nga, IvovicAleksandar, TanYao Fang, JentzEmelien Mariella, BatchuluunBattsetseg, GohilHimaben, WheelerMichael B, JosephJamie W, GiaccaAdria, MamelakMortimer

Increases NADPH/NADP+ ratio
Prevents lipotoxicity

Gamma-hydroxybutyrate (GHB) is an endogenous compound with antioxidant properties. This study investigated the effects of GHB on palmitate-induced lipotoxicity in mouse islets. The authors found that GHB protected mouse islets from palmitate-induced reactive oxygen species, prevented lipotoxic inhibition of glucose-stimulated insulin secretion, and increased the NADPH/NADP+ ratio. These findings suggest that GHB may have therapeutic potential for the treatment of type 2 diabetes.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

A pilot study on the effects of sodium oxybate on sleep architecture and daytime alertness in narcolepsy.

Author: MamelakMortimer, BlackJed, MontplaisirJacques, RistanovicRuzica

Improved daytime functioning
Improved sleep architecture

Nocturnal administration of sodium oxybate in patients with narcolepsy significantly improved sleep architecture, including slow-wave sleep, delta power, and rapid eye movement sleep. This resulted in significant improvements in daytime functioning, such as reduced daytime sleepiness.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study.

Author: DauvilliersYves, ArnulfIsabelle, Foldvary-SchaeferNancy, MorseAnne Marie, ŠonkaKarel, ThorpyMichael J, MignotEmmanuel, ChandlerPatricia, ParvataneniRupa, BlackJed, SterkelAmanda, ChenDan, SkobierandaFranck, BoganRichard K

Idiopathic hypersomnia treatment

This study aimed to evaluate the safety and efficacy of lower-sodium oxybate in idiopathic hypersomnia, a central hypersomnolence disorder mainly characterized by excessive daytime sleepiness.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

The effects of sodium oxybate on core body and skin temperature regulation in narcolepsy.

Author: van der HeideAstrid, DonjacourClaire E H M, PijlHanno, ReijntjesRobert H A M, OvereemSebastiaan, LammersGert J, Van SomerenEus J W, FronczekRolf

narcolepsy treatment
skin temperature normalization

The study found that sodium oxybate, a drug used to treat narcolepsy, increased proximal skin temperature in patients with narcolepsy, bringing it closer to the levels seen in healthy controls. This suggests that sodium oxybate may improve the sleep-wake cycle in patients with narcolepsy.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Effectiveness and tolerability in people with narcolepsy transitioning from sodium oxybate to low-sodium oxybate: Data from the real-world TENOR study.

Author: BaeCharles J, ZeePhyllis C, LearyEileen B, FullerDouglas S, MacfaddenWayne, CandlerShawn, SteiningerTeresa L, HusainAatif M

Improved cognitive function
Improved sleep quality
Improved sleepiness
Dizziness
Hyperhidrosis
Sleep inertia

Transitioning from sodium oxybate (SXB) to low-sodium oxybate (LXB) was associated with maintenance of effectiveness and tolerability in patients with narcolepsy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Changes in Cataplexy Frequency in a Clinical Trial of Lower-Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications.

Author: DauvilliersYves, ŠonkaKarel, BoganRichard K, PartinenMarkku, Del Rio VillegasRafael, Foldvary-SchaeferNancy, SkowronskiRoman, ChenAbby, BlackJed, SkobierandaFranck, ThorpyMichael J

Improved cataplexy
Reduced sodium

Lower-sodium oxybate (LXB) was found to effectively improve cataplexy and excessive daytime sleepiness in individuals with narcolepsy. This study further analyzes data from a previous trial exploring the clinical course and feasibility of transitioning from other anticataplectics to LXB monotherapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Long-term safety and maintenance of efficacy of sodium oxybate in the treatment of narcolepsy with cataplexy in pediatric patients.

Author: LecendreuxMichel, PlazziGiuseppe, DauvilliersYves, RosenCarol L, RuoffChad, BlackJed, ParvataneniRupa, GuintaDiane, WangY Grace, MignotEmmanuel

Long-term efficacy
Safe treatment
Enuresis
Nausea
Vomiting

Sodium oxybate demonstrated long-term maintenance of efficacy in pediatric narcolepsy with cataplexy, with a safety profile consistent with that observed in adults.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

21.

Narcolepsy treatment in Sweden: An observational study.

Author: GauffinHelena, FastThomas, KomkovaAnastasija, BerntssonShala, BoströmInger, LandtblomAnne-Marie

Side effects

Modafinil, methylphenidate, and amphetamine were the most commonly prescribed medications for narcolepsy in Sweden, with modafinil being more common in women and amphetamine in men. Patients treated with sodium oxybate had more outpatient visits, likely due to the need for monitoring potential severe side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : English

22.

GHB toxicokinetics and renal monocarboxylate transporter expression are influenced by the estrus cycle in rats.

Author: WeiHao, CaoJieyun, FallertTyler, YeoSu, FelmleeMelanie A

GHB toxicokinetics
GHB overdose

Gamma-hydroxybutyric acid (GHB) is a dangerous drug that can lead to overdose. Currently, there are no specific treatments for GHB overdose. This study investigates the role of monocarboxylate transporters (MCTs) in GHB toxicokinetics and renal clearance, exploring how their expression is regulated by sex hormones. Understanding these mechanisms is crucial for developing potential therapies for GHB overdose.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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