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
-

Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.

First Posted Date
2006-10-03
Last Posted Date
2017-06-01
Lead Sponsor
Stanford University
Target Recruit Count
48
Registration Number
NCT00383643
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients

Phase 3
Completed
Conditions
First Posted Date
2002-11-15
Last Posted Date
2005-06-24
Lead Sponsor
Orphan Medical
Target Recruit Count
200
Registration Number
NCT00049803
Locations
🇨🇦

The Sleep Disorders Clinic of the Centre for Sleep and Chronobiology, Toronto, Ontario, Canada

🇨🇦

Vancouver Hospital -- Sleep Disorders Clinic, Vancouver, British Columbia, Canada

🇺🇸

Sleep Disorders Center of Georgia, Atlanta, Georgia, United States

and more 40 locations
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