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
-

Sodium Oxybate in Patients With Alternating Hemiplegia of Childhood (AHC-SO)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-07-02
Last Posted Date
2014-03-31
Lead Sponsor
University of Utah
Target Recruit Count
6
Registration Number
NCT00931164
Locations
🇺🇸

University of Utah Hospital, Salt Lake City, Utah, United States

Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

First Posted Date
2008-12-05
Last Posted Date
2011-08-19
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
129
Registration Number
NCT00803023
Locations
🇺🇸

Sun Research Institute, San Antonio, Texas, United States

🇺🇸

Arizona Research Center, Phoenix, Arizona, United States

🇺🇸

Dba 21st Century Neurology, Phoenix, Arizona, United States

and more 29 locations

The Effect of Sodium Oxybate on Sleep Architecture

First Posted Date
2008-09-01
Last Posted Date
2018-02-23
Lead Sponsor
Tufts Medical Center
Registration Number
NCT00744393
Locations
🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

Safety and Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients

Phase 4
Terminated
Conditions
First Posted Date
2008-06-27
Last Posted Date
2010-07-07
Lead Sponsor
Clayton Sleep Insititute
Target Recruit Count
4
Registration Number
NCT00706186
Locations
🇺🇸

Clayton Sleep Institute, St. Louis, Missouri, United States

Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-03-24
Last Posted Date
2022-10-06
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
30
Registration Number
NCT00641186

Multiple-dose,Double-blind,Placebo-controlled Study of Sodium Oxybate in Patients With Essential Tremor

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-01-18
Last Posted Date
2012-01-23
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
19
Registration Number
NCT00598078
Locations
🇺🇸

Quest Research Institiute, Bingham Farms, Michigan, United States

Sodium Oxybate in Schizophrenia With Insomnia

First Posted Date
2008-01-15
Last Posted Date
2016-02-08
Lead Sponsor
Nathan Kline Institute for Psychiatric Research
Target Recruit Count
8
Registration Number
NCT00594256
Locations
🇺🇸

Nathan Kline Insitute for Psychiatric Research, Orangeburg, New York, United States

Sodium Oxybate in the Treatment of Binge Eating Disorder

Phase 2
Completed
Conditions
Interventions
First Posted Date
2007-08-10
Last Posted Date
2011-06-22
Lead Sponsor
Lindner Center of HOPE
Target Recruit Count
15
Registration Number
NCT00514995
Locations
🇺🇸

Lindner Center of HOPE, Mason, Ohio, United States

Enhancing Slow Wave Sleep With Sodium Oxybate

Phase 4
Completed
Conditions
First Posted Date
2007-07-25
Last Posted Date
2008-09-26
Lead Sponsor
St. Luke's Hospital, Chesterfield, Missouri
Target Recruit Count
60
Registration Number
NCT00506974
Locations
🇺🇸

Sleep Medicine and Research Center at St. Luke's Hospital, Chesterfield, Missouri, United States

Use of Xyrem to Improve Sleep in Chronic Fatigue Syndrome

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2007-07-10
Last Posted Date
2016-05-19
Lead Sponsor
University of Medicine and Dentistry of New Jersey
Target Recruit Count
17
Registration Number
NCT00498485
Locations
🇺🇸

UMDNJ - Pain & Fatigue Study Center, ADMC 1618, Newark, New Jersey, United States

© Copyright 2024. All Rights Reserved by MedPath