Sodium oxybate

sodium ''gamma''-hydroxybutyrate
Sodium oxybate is a prescription medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness.wikipedia
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Narcolepsy

narcolepticdifficulty in controlling her sleepdifficulty staying awake
Sodium oxybate is a prescription medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness.
Medications used include modafinil, sodium oxybate and methylphenidate.

Controlled Substances Act

Schedule ISchedule IIschedule III
The clinical trials for narcolepsy were conducted just as abuse of GHB as a club drug and date rape drug became a matter of public concern; in 2000 GHB was made a Schedule I controlled substance, while sodium oxybate, when used under an FDA NDA or IND, was classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act, with illicit use subject to Schedule I penalties.
Congress has sometimes scheduled other substances through legislation such as the Hillory J. Farias and Samantha Reid Date-Rape Prevention Act of 2000, which placed gamma hydroxybutyrate (GHB) in Schedule I and sodium oxybate (the isolated sodium salt in GHB) in Schedule III.

Jazz Pharmaceuticals

Celator Pharmaceuticals
Orphan Medical had developed it and was acquired by Jazz Pharmaceuticals in 2005.
One of the company's most significant products is the United States Food and Drug Administration (FDA) approved drug Xyrem (sodium oxybate), the sodium salt of the naturally occurring neurotransmitter γ-Hydroxybutyric acid (GHB).

Excessive daytime sleepiness

daytime sleepinessEDSexcessive sleepiness
Sodium oxybate is a prescription medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness.
Drugs like modafinil, Armodafinil, Xyrem (sodium oxybate) oral solution, have been approved as treatment for EDS symptoms in the U.S. There is declining usage of other drugs such as methylphenidate (Ritalin), dextroamphetamine (Dexedrine), amphetamine (Adderall), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), and pemoline (Cylert), as these psychostimulants may have several adverse effects and may lead to dependency when illicitly misused.

Cataplexy

sudden muscle weakness
Sodium oxybate is a prescription medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness.
Sodium oxybate and gamma-hydroxybutyrate has been found to be effective at reducing the number of cataplexy episodes.

Gamma-Hydroxybutyric acid

GHBγ-hydroxybutyric acidgamma-hydroxybutyrate
Sodium oxybate is the sodium salt of γ-hydroxybutyric acid (GHB).
It is commonly used in the form of a salt, such as sodium γ-hydroxybutyrate (Na.GHB, sodium oxybate, or Xyrem) or potassium γ-hydroxybutyrate (K.GHB, potassium oxybate).

Fibromyalgia

fibrositismuscular rheumatismfibromyalgia syndrome
In 2010 the FDA rejected Jazz' New Drug Application for use of sodium oxybate in fibromyalgia.
Sodium oxybate increases growth hormone production levels through increased slow-wave sleep patterns.

NHS England

NHSEnglandEngland's National Health Service
NHS England authorises and pays for sodium oxybate by means of individual funding requests on the basis of exceptional circumstances.
It authorises and pays for treatment of narcolepsy with sodium oxybate by means of individual funding requests on the basis of exceptional circumstances.

Pandemrix

The British Department of Health pays for the medication for 80 patients who are taking legal action over problems linked to the use of the swine flu vaccine Pandemrix at a cost of £12,000 a year.
In 2015 it was reported that the British Department of Health was paying for Sodium oxybate medication for 80 patients who are taking legal action over problems linked to the use of the swine flu vaccine, at a cost to the government of £12,000 per patient per year.

Prescription drug

prescriptionprescription drugsprescription medication
Sodium oxybate is a prescription medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness.

Anesthetic

anaestheticanestheticsanaesthetics
It is used sometimes in France and Italy as an anesthetic given intravenously; it is also used in Italy to treat alcohol addiction and alcohol withdrawal syndrome.

Club drug

club drugsparty drugsdrug use
The clinical trials for narcolepsy were conducted just as abuse of GHB as a club drug and date rape drug became a matter of public concern; in 2000 GHB was made a Schedule I controlled substance, while sodium oxybate, when used under an FDA NDA or IND, was classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act, with illicit use subject to Schedule I penalties.

Date rape drug

date rape drugsdate-rape drugstupefying
The clinical trials for narcolepsy were conducted just as abuse of GHB as a club drug and date rape drug became a matter of public concern; in 2000 GHB was made a Schedule I controlled substance, while sodium oxybate, when used under an FDA NDA or IND, was classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act, with illicit use subject to Schedule I penalties.

Risk Evaluation and Mitigation Strategies

risk evaluation and mitigation strategyRisk Evaluation and Mitigation Strategy (REMS)
Sodium oxybate was approved for use by the FDA to treat symptoms of narcolepsy in 2002 with a strict risk evaluation and mitigation strategy (REMS) program mandated by the FDA.

Boxed warning

black box warningblack box warningsblack-box warning
The US label for sodium oxybate also has a black box warning because it is a central nervous system depressant and may cause respiratory depression, seizures, coma, or death, especially if used in combination with other CNS depressants, such as alcohol and its use may cause dependence.

Central nervous system depression

central nervous system depressantCNS depressantCNS depression
The US label for sodium oxybate also has a black box warning because it is a central nervous system depressant and may cause respiratory depression, seizures, coma, or death, especially if used in combination with other CNS depressants, such as alcohol and its use may cause dependence.

Hypoventilation

respiratory depressiondecreased breathinghypoventilating
The US label for sodium oxybate also has a black box warning because it is a central nervous system depressant and may cause respiratory depression, seizures, coma, or death, especially if used in combination with other CNS depressants, such as alcohol and its use may cause dependence.

Alcohol

alcoholssecondary alcoholtertiary alcohol
The US label for sodium oxybate also has a black box warning because it is a central nervous system depressant and may cause respiratory depression, seizures, coma, or death, especially if used in combination with other CNS depressants, such as alcohol and its use may cause dependence.

Substance dependence

addictiondependencedrug dependence
The US label for sodium oxybate also has a black box warning because it is a central nervous system depressant and may cause respiratory depression, seizures, coma, or death, especially if used in combination with other CNS depressants, such as alcohol and its use may cause dependence.

Canada

🇨🇦CanadianCAN
In Canada and the European Union (EU) it was classified as a Schedule III and a Schedule IV controlled substance, respectively.

European Union

EUEuropeanEurope
In Canada and the European Union (EU) it was classified as a Schedule III and a Schedule IV controlled substance, respectively.

Convention on Psychotropic Substances

Schedule IVSchedule IUnited Nations Convention on Psychotropic Substances
In Canada and the European Union (EU) it was classified as a Schedule III and a Schedule IV controlled substance, respectively.

Drug development

developmentdevelopedclinical development
Orphan Medical had developed it and was acquired by Jazz Pharmaceuticals in 2005.

UCB (company)

UCBUCB PharmaSchwarz
The drug is marketed in Europe by UCB.

Off-label use

off-labeloff labeloff-label marketing
Jazz raised the price of the drug dramatically after it acquired Orphan, and paid a $20M fine for off-label marketing of the drug in 2007.