• Sodium oxybate, sold under the brand name Xyrem among others, is a medication used to treat symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness. (wikipedia.org)
  • Sodium oxybate is available only through a restricted distribution program called the Xywav and Xyrem REMS Program or the Lumryz REMS Program. (medlineplus.gov)
  • Sodium oxybate (Xyrem) comes as an immediate-release solution (liquid) to mix with water and take by mouth. (medlineplus.gov)
  • Sodium oxybate (Xyrem) immediate-release oral solution is usually taken twice each night because sodium oxybate wears off after a short time, and the effects of one dose will not last for the entire night. (medlineplus.gov)
  • If you are taking the oral solution, place your second dose of sodium oxybate (Xyrem) in a safe place near your bed (or in an safe place to give to your child) before sleep. (medlineplus.gov)
  • October 27, 2009 (Phoenix, Arizona) - Sodium oxybate ( Xyrem , Jazz Pharmaceuticals Inc.), a novel sleep medication approved by the US Food and Drug Administration (FDA) for the treatment of narcolepsy and cataplexy, offers safe and significant reduction of pain and fatigue in patients with fibromyalgia, according to a study presented here at the American Association of Pain Management 20th annual clinical meeting. (medscape.com)
  • Xyrem, oxybate sodium, more. (medscape.com)
  • Sodium oxybate (Xyrem) works well to control cataplexy. (nih.gov)
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") today announced the launch of its authorized generic for Xyrem ® 1 (Sodium Oxybate) oral solution CIII in the United States. (malvern-online.com)
  • Because of these risks, Sodium Oxybate is available only through the XYWAV and XYREM REMS. (malvern-online.com)
  • Patients must be enrolled in the XYWAV and XYREM REMS to receive Sodium Oxybate Oral Solution. (malvern-online.com)
  • Belgium's UCB says that it is expecting to win final European approval for Xyrem (sodium oxybate) in the treatment of cataplexy in adults with narcolepsy some time during the fourth quarter of 2005 after winning the backing of the European advisory body, the CHMP, yesterday. (pharmatimes.com)
  • Xyrem (sodium oxybate) is available in Australia, but it is not registered. (sleephub.com.au)
  • Xyrem (sodium oxybate) is available for use in Australia under specific circumstances. (sleephub.com.au)
  • Sodium Oxybate (Xyrem): Unlocking Sweet Dreams! (dibesity.com)
  • Sodium oxybate was approved for use by the US Food and Drug Administration (FDA) to treat symptoms of narcolepsy in 2002, with a strict risk evaluation and mitigation strategy (REMS) program mandated by the FDA. (wikipedia.org)
  • 15, 27-28 The major use of sodium oxybate is in treating two of the symptoms of narcolepsy - cataplexy (sudden muscle weakness) and excessive daytime sleepiness. (wikipedia.org)
  • Reviews of sodium oxybate concluded that it is well tolerated and associated with "significant reductions in cataplexy and daytime sleepiness," and that its effectiveness "in treating major, clinically relevant narcolepsy symptoms and sleep architecture abnormalities" has been established. (wikipedia.org)
  • The sodium oxybate approved dose regimen for the treatment of alcohol dependence (i.e. around 3.2g/day) is lower than the one for the treatment of narcolepsy (4.5-9g/night). (wikipedia.org)
  • Sodium oxybate is used to prevent attacks of cataplexy (episodes of muscle weakness that begin suddenly and last for a short time) and excessive daytime sleepiness in adults and children 7 years of age and older who have narcolepsy (a sleep disorder that may cause extreme sleepiness, sudden uncontrollable urge to sleep during daily activities, and cataplexy). (medlineplus.gov)
  • Sodium oxybate works to treat narcolepsy and cataplexy by reducing activity in the brain. (medlineplus.gov)
  • To assess the effectiveness of sodium oxybate therapy, modafinil therapy and the combination of the two for excessive daytime sleepiness in narcolepsy patients previously taking modafinil. (nih.gov)
  • Sodium oxybate, a CNS depressant and a salt of gamma hydroxybutyrate (GABA metabolite), is indicated for cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. (medscape.com)
  • Cataplexy in patients with narcolepsy can be treated with the CNS depressant sodium oxybate. (medscape.com)
  • Avadel's commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. (tipranks.com)
  • LUMRYZ, is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. (tipranks.com)
  • With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. (tipranks.com)
  • Effect of sodium oxybate on body mass index in pediatric patients with narcolepsy. (nih.gov)
  • Other medicines commonly used for narcolepsy include sodium oxybate and newer "wake promoting agents" such as pitolisant and solriamfetol. (nih.gov)
  • The Woolcock was recently involved in a global trial of the long-acting form of the drug sodium oxybate, currently being introduced as a first-line medication for narcolepsy in countries overseas which can improve sudden loss of muscle control (cataplexy) and help patients sleep at night. (edu.au)
  • Sodium oxybate, also known as gamma hydroxybutyrate (GHB), is a CNS depressant used to treat patients with EDS and cataplexy. (medscape.com)
  • The precise mechanism by which sodium oxybate produces an effect on cataplexy is unknown. (medscape.com)
  • Several newer wake-promoting agents and psychostimulants have also been developed, including sodium oxybate, which has a role in the treatment of cataplexy and as an adjunctive wake-promoting agent, and pitolisant, a selective histamine H3 receptor inverse agonist that is currently only available in Europe. (flutrackers.com)
  • Concomitant use with divalproex sodium: An initial reduction in Sodium Oxybate Oral Solution dose of at least 20% is recommended ( 2.5 , 7.2 ). (nih.gov)
  • In August 2021, the FDA approved, calcium/magnesium/potassium/sodium oxybates (Xywav), the first drug indicated for idiopathic hypersomnia. (medscape.com)
  • Xywav is a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate (gamma-hydroxybutyrate). (medscape.com)
  • These highlights do not include all the information needed to use SODIUM OXYBATE ORAL SOLUTION safely and effectively. (nih.gov)
  • CNS depression: Use caution when considering the concurrent use of Sodium Oxybate Oral Solution with other CNS depressants ( 5.1 ). (nih.gov)
  • Caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that Sodium Oxybate Oral Solution does not affect them adversely ( 5.1 ). (nih.gov)
  • High sodium content in Sodium Oxybate Oral Solution: Monitor patients with heart failure, hypertension, or impaired renal function ( 5.8 ). (nih.gov)
  • Sodium Oxybate Oral Solution carries a boxed warning for central nervous system (CNS) depression and abuse and misuse. (malvern-online.com)
  • In this context, a study published in 2019 analyzed safety data from 40 clinical trials and from pharmacovigilance database covering around 260,000 alcohol dependent patients treated with sodium oxybate in Italy and Austria. (wikipedia.org)
  • In 2023, a PhD thesis conducted at the University of Amsterdam, presented results of large clinical trials, including a phase 3 trial, and of meta-analyses which confirmed the efficacy, the good tolerance and the safety of sodium oxybate in the maintenance of abstinence, particularly in severe alcohol-dependent patients. (wikipedia.org)
  • Sodium oxybate, the sodium salt of gamma-hydroxybutyrate, a metabolite of gamma-aminobutyric acid (GABA), is used specifically for the treatment of deep sleep pattern disturbances, and because studies have shown that fibromyalgia patients commonly have deep sleep disturbances, scientists suspected that the drug could help treat the condition's symptoms. (medscape.com)
  • Previous proof-of-concept studies offered evidence that sodium oxybate can reduce pain and fatigue and provide polysomnographic improvements in sleep in patients with fibromyalgia, compared with placebo. (medscape.com)
  • The patients were assigned to receive sodium oxybate 4.5 g/night, sodium oxybate 6.0 g/night, or placebo in divided doses at bedtime and 2.5 to 4 hours later, over the course of 14 weeks. (medscape.com)
  • Not only do the studies show that sodium oxybate treatment improves patients' sleep and fatigue complaints, interestingly enough, there's a very significant improvement in their pain," he said. (medscape.com)
  • In part 3 of this 4-part series, Michael Thorpy, MD, talks about advances in sodium oxybate medication formulations and how different formulations can help patients depending on their needs. (ajmc.com)
  • Various types of sodium oxybate medications provide options for patients who have sleep disorders, even those that need more or less sodium intake, says Michael Thorpy, MD, professor of neurology at the Albert Einstein College of Medicine, and director of the Sleep Disorder Center at Montefiore Medical Center. (ajmc.com)
  • What monitoring and educational measures should be in place for patients prescribed sodium-based sleep medications to ensure they maintain a balanced sodium intake and follow low-sodium guidelines effectively? (ajmc.com)
  • There are many patients who continue to take the sodium form of sodium oxybate, and not the low-sodium formulation. (ajmc.com)
  • For many patients who have had difficulty in taking the medication in the middle of the night, they prefer the sodium oxybate that's given once a night. (ajmc.com)
  • However, patients who have cardiovascular disorders or renal disorders or problems with excessive fluid retention would be better not to take the sodium formulation and would be better on the low-sodium formulation. (ajmc.com)
  • Patients need to be advised that there are some medical conditions that they need to be aware of that would restrict them from taking the highest sodium content. (ajmc.com)
  • Patients received unchanged doses of modafinil (with sodium-oxybate placebo) during a 2-week baseline phase. (nih.gov)
  • Patients on Sodium Oxybate should be monitored for confusion, anxiety, and suicidality. (malvern-online.com)
  • Approximately 70% of patients were subsequently treated with sodium oxybate, which is a general anaesthetic commonly used to treat narcoleptic sleep disorders. (meresearch.org.uk)
  • While sodium oxybate itself it not a long term solution to the sleep problems of ME/CFS patients - it has been associated with adverse effects and addiction - the findings point to the need for treatment aimed at disrupted sleep in a range of chronically ill patients, including those meeting the definition of ME/CFS. (meresearch.org.uk)
  • 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 central nervous system depressants, such as alcohol and its use may cause dependence. (wikipedia.org)
  • Sodium oxybate is in a class of medications called central nervous system depressants. (medlineplus.gov)
  • Taking Sodium Oxybate with other Central Nervous System (CNS) depressants has been associated with trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death. (malvern-online.com)
  • Sodium oxybate (Lumryz) also comes as an extended-release (long-acting) powder for oral suspension to be mixed with water and take by mouth. (medlineplus.gov)
  • Sodium oxybate (Lumryz) extended-release powder for oral suspension is usually taken once daily at bedtime. (medlineplus.gov)
  • In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose. (tipranks.com)
  • Sodium oxybate must be taken on an empty stomach, so the first dose should be taken at least 2 hours after eating. (medlineplus.gov)
  • Do not take your bedtime dose(s) of sodium oxybate until you or your child are in bed and are ready to go to sleep for the night. (medlineplus.gov)
  • Following a baseline polysomnogram and Maintenance of Wakefulness Test, they were randomly assigned to 1 of 4 treatment groups: sodium-oxybate placebo plus modafinil placebo, sodium oxybate plus modafinil placebo, modafinil plus sodium-oxybate placebo, or sodium oxybate plus modafinil. (nih.gov)
  • The following medications may be considered for treatment of RBD, but evidence is very limited with only a few subjects having been studied for each medication: zopiclone, benzodiazepines other than clonazepam, Yi-Gan San, desipramine, clozapine, carbamazepine, and sodium oxybate. (aasm.org)
  • 2023. Effects of sodium oxybate on hypocretin/orexin and locus coeruleus neurons . (ucla.edu)
  • Results showed that sodium oxybate was well-tolerated, risks were controlled, and no safety concerns were reported. (wikipedia.org)
  • Talk to your doctor about the risks of taking sodium oxybate. (medlineplus.gov)
  • In a 2014 review, Gillian Keating described sodium oxybate as a "useful option for the treatment of alcohol withdrawal syndrome and for the maintenance of abstinence in alcohol dependence. (wikipedia.org)
  • Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with sodium oxybate and each time you refill your prescription. (medlineplus.gov)
  • Reference: Treatment of the narcoleptiform sleep disorder in chronic fatigue syndrome and fibromyalgia with sodium oxybate. (meresearch.org.uk)
  • Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. (fightingfatigue.org)
  • The Treatment of Parkinson's Disease with Sodium Oxybate. (mysciencework.com)
  • Sodium oxybate can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines. (drugs.com)
  • Over the years, several studies were conducted to further substantiate sodium oxybate efficacy in these indications. (wikipedia.org)
  • Sodium oxybate was administered as 6 g nightly for 4 weeks and was then increased to 9 g nightly for 4 additional weeks. (nih.gov)
  • Prescribing information for sodium oxybate states coadministration with alcohol or insomnia drugs is contraindicated because of additive CNS depression. (medscape.com)
  • But so far, we don't have any actual evidence that the extra salt intake associated with sodium oxybate has caused any increase in cardiovascular concerns, which is the major concern about the extra salt, as a potential that may cause an increase in cardiovascular disorders, such as hypertension/high blood pressure. (ajmc.com)
  • The strongest evidence is for clomipramine, fluoxetine, and sodium oxybate. (medscape.com)
  • Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL) is a generic version of Precedex ® Injection. (malvern-online.com)
  • Daniel J. Clauw, MD, professor of medicine in the Division of Rheumatology at the University of Michigan, Ann Arbor, said he felt that sodium oxybate represents an exciting new approach to fibromyalgia, addressing an important part of the brain that is not targeted by other therapies. (medscape.com)
  • anhydrous ethyl alcohol 10%, benzoic acid 4.25%, benzyl alcohol 1.5% as preservative, propylene glycol 40%, sodium hydroxide to adjust pH, and water for injection. (pharmasave.com)
  • in 2000 GHB was made a Schedule I controlled substance, while sodium oxybate, when used under an FDA NDA or IND application, was classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act, with illicit use subject to Schedule I penalties. (wikipedia.org)
  • Sodium oxybate is another name for GHB, a substance that is often illegally sold and abused, especially by young adults in social settings such as nightclubs. (medlineplus.gov)
  • Short-acting sodium oxybate, classed as a controlled substance in Australia (Schedule 8) is only approved for use under special circumstances. (edu.au)
  • The standard original form of sodium oxybate is a medication that's taken twice at night. (ajmc.com)
  • Then there's a low-sodium formulation that's also taken twice at night. (ajmc.com)
  • But there's a new formulation of sodium oxybate, which is a once-a-night formulation. (ajmc.com)
  • Some medications should not be taken with sodium oxybate. (medlineplus.gov)
  • Make sure you have discussed any medications you are currently taking or plan to take before starting sodium oxybate with your doctor and pharmacist. (medlineplus.gov)
  • Before starting, stopping, or changing any medications while taking sodium oxybate, please get the advice of your doctor or pharmacist. (medlineplus.gov)
  • Sodium oxybate may cause serious side effects, including serious or life-threatening breathing problems. (medlineplus.gov)
  • Sodium oxybate may cause serious side effects. (drugs.com)