Sodium oxybate

Generic Name
Sodium oxybate
Brand Names
Lumryz, Xyrem, Xywav
Drug Type
Small Molecule
Chemical Formula
C4H7NaO3
CAS Number
502-85-2
Unique Ingredient Identifier
7G33012534
Background

Sodium oxybate (Xyrem) is a central nervous system (CNS) depressant used to treat cataplexy or excessive daytime sleepiness associated with narcolepsy. It is a sodium salt of gamma-Hydroxybutyric acid, an endogenous cerebral inhibitory neurotransmitter and a metabolite of the inhibitory neurotransmitter GABA. Due to its physiological effects, sodium oxybate is associated with a risk for substance misuse and abuse. Sodium oxybate has been misused to stimulate body growth and to induce euphoria, disinhibition, and sexual arousal as a "party drug" or "club drug." For safety reasons, sodium oxybate is a controlled substance only available through a restricted program in approved countries.

An extended-release oral suspension formulation of sodium oxybate for narcolepsy, marketed under the brand name LUMRYZ, gained tentative FDA approval in July 2022 and was fully approved in May 2023. In some countries, sodium oxybate has been investigated and used in alcohol withdrawal syndrome (AWS) to aid abstinence maintenance in alcohol use disorders.

Indication

Sodium oxybate is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. In the US and in Europe, the drug is approved for use in patients 7 years of age and older while in Canada, it is not recommended in children under the age of 18, unless clearly needed.

Associated Conditions
Cataplexy, Excessive Daytime Sleepiness
Associated Therapies
-

Evaluation of the Efficacy of Sodium Oxybate in the Long-term Maintenance of Abstinence in Alcoholic Patients

First Posted Date
2020-12-01
Last Posted Date
2020-12-04
Lead Sponsor
Laboratorio Farmaceutico Ct S.r.l.
Target Recruit Count
314
Registration Number
NCT04648423

Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate

First Posted Date
2019-07-05
Last Posted Date
2023-05-10
Lead Sponsor
Stanford University
Target Recruit Count
24
Registration Number
NCT04006925
Locations
🇺🇸

Stanford University, Palo Alto, California, United States

Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-09-25
Last Posted Date
2023-10-26
Lead Sponsor
Kristina Simonyan
Target Recruit Count
140
Registration Number
NCT03292458
Locations
🇺🇸

Massachusetts Eye and Ear, Boston, Massachusetts, United States

Sodium Oxybate in Patients With Episodic and Chronic Cluster Headache

First Posted Date
2015-12-22
Last Posted Date
2015-12-22
Lead Sponsor
Ramin Khatami
Target Recruit Count
60
Registration Number
NCT02637648

A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics

First Posted Date
2014-08-13
Last Posted Date
2015-05-29
Lead Sponsor
Concert Pharmaceuticals
Target Recruit Count
28
Registration Number
NCT02215499
Locations
🇬🇧

Quotient Clinical Ltd., Ruddington, Nottingham, United Kingdom

Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's Disease

First Posted Date
2014-04-10
Last Posted Date
2021-01-25
Lead Sponsor
Christian Baumann
Target Recruit Count
16
Registration Number
NCT02111122
Locations
🇨🇭

Department of Neurology, Zurich, Switzerland

Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2014-02-14
Last Posted Date
2018-04-26
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
36
Registration Number
NCT02063217
Locations
🇺🇸

Washington University Medical School, Saint Louis, Missouri, United States

SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)

First Posted Date
2014-02-05
Last Posted Date
2020-11-18
Lead Sponsor
Imperial College London
Target Recruit Count
13
Registration Number
NCT02055898
Locations
🇬🇧

Wellcome CRF, Imperial College, Hammersmith Campus, London, United Kingdom

Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-10-11
Last Posted Date
2017-11-22
Lead Sponsor
Kristina Simonyan
Target Recruit Count
53
Registration Number
NCT01961297
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

Sodium Oxybate in Patients With Chronic Fatigue Syndrome.

Phase 4
Withdrawn
Conditions
Interventions
First Posted Date
2012-04-25
Last Posted Date
2022-12-15
Lead Sponsor
University Hospital, Ghent
Registration Number
NCT01584934
Locations
🇧🇪

Ghent University Hospital, Ghent, Belgium

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