pharmacopeia
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/api/v1/drug/oxybate

Boxed warning

CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND ABUSE AND MISUSE Central Nervous System Depression LUMRYZ (sodium oxybate) is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with LUMRYZ at recommended doses [see Warnings and Precautions (5.1) ] . Many patients who received sodium oxybate during clinical trials in narcolepsy were receiving central nervous system stimulants [see Clinical Trials (14) ] . Abuse and Misuse LUMRYZ (sodium oxybate) is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death [see Warnings and Precautions (5.2) ] . Because of the risks of CNS depression and abuse and misuse, LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LUMRYZ REMS [see Warnings and Precautions (5.3) ]. WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND ABUSE AND MISUSE See full prescribing information for complete boxed warning. Central Nervous System Depression • LUMRYZ is a CNS depressant, and respiratory depression can occur with LUMRYZ use ( 5.1 , 5.4 ) Abuse and Misuse • LUMRYZ is the sodium salt of gamma-hydroxybutyrate (GHB).

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: GABA B Agonists; Unknown Cellular or Molecular Interaction.

GABA B

Indications

Sourced from openFDA
  • LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. LUMRYZ is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ).ICD-10: G47.419

Contraindications

Sourced from openFDA
  • LUMRYZ is contraindicated for use in: ● combination with sedative hypnotics [see Warnings and Precautions (5.1) ] ● combination with alcohol [see Warnings and Precautions (5.1) ] ● patients with succinic semialdehyde dehydrogenase deficiency [see Clinical Pharmacology (12.3) ] • In combination with sedative hypnotics or alcohol ( 4 ). • Succinic semialdehyde dehydrogenase deficiency ( 4 ).contraindicated

Dosage & administration

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Dosing for Adults: • Initiate dosage at 4.5 g once per night orally ( 2.1 ). • Titrate to effect in increments of 1.5 g per night at weekly intervals ( 2.1 ). • Recommended dosage range: 6 g to 9 g once per night orally ( 2.1 ). Dosing for Pediatric Patients (7 Years of Age and Older): • The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight ( 2.2 ) • Pediatric patients 7 years and older weighing at least 45 kg : The recommended starting dosage is 4.5 g once per night. Increase the dosage by 1.5 g per night at weekly intervals to the maximum recommended dosage of 9 g once per night orally. The dosage may be gradually titrated based on efficacy and tolerability ( 2.2 ). • Pediatric patients 7 years and older weighing less than 45 kg : Because the recommended starting dosage cannot be achieved with the available strengths of LUMRYZ, use another sodium oxybate product to initiate treatment ( 2.2 ). Important Administration Information • Prepare the dose of LUMRYZ prior to bedtime; suspend dose in approximately ⅓ cup of water (with or without calorie-free drink mix or flavored water enhancer) in the mixing cup provided ( 2.3 ). • Allow 2 hours after eating before dosing ( 2.3 ). • Take LUMRYZ while in bed and lie down after dosing ( 2.3 ). 2.1 Adult Dosing Information The recommended starting dosage of LUMRYZ in adults is 4.5 grams (g) once per night administered orally. Increase the dosage by 1.5 g per night at weekly intervals to the recommended dosage range of 6 g to 9 g once per night orally.

Warnings & precautions

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• CNS depression: Use caution when considering the concurrent use of LUMRYZ with other CNS depressants ( 5.1 ). • 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 LUMRYZ does not affect them adversely ( 5.1 ). • Depression and suicidality: Monitor patients for emergent or increased depression and suicidality ( 5.5 ). • Confusion/Anxiety: Monitor for impaired motor/cognitive function ( 5.6 ). • Parasomnias: Evaluate episodes of sleepwalking ( 5.7 ). • High sodium content in LUMRYZ: Monitor patients with heart failure, hypertension, or impaired renal function ( 5.8 ). 5.1 Central Nervous System Depression LUMRYZ is a central nervous system (CNS) depressant. Clinically significant respiratory depression and obtundation has occurred in patients treated with immediate-release sodium oxybate at recommended doses in clinical trials and may occur in patients treated with LUMRYZ at recommended doses. LUMRYZ is contraindicated in combination with alcohol and sedative hypnotics. The concurrent use of LUMRYZ with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating antiepileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions appear in other sections of the labeling: ● CNS Depression [see Warnings and Precautions (5.1) ] ● Abuse and Misuse [see Warnings and Precautions (5.2) ] ● Respiratory Depression and Sleep-Disordered Breathing [see Warnings and Precautions (5.4) ] ● Depression and Suicidality [see Warnings and Precautions (5.5) ] ● Other Behavioral or Psychiatric Adverse Reactions [see Warnings and Precautions (5.6) ] ● Parasomnias [see Warnings and Precautions (5.7) ] ● Use in Patients Sensitive to High Sodium Intake [see Warnings and Precautions (5.8) ] Most common adverse reactions in adults (incidence ≥ 5% and greater than placebo) reported for any dose of LUMRYZ were nausea, dizziness, enuresis, headache, and vomiting ( 6.1 ). Most common adverse reactions for pediatric patients (≥ 5%) in a study with immediate-release sodium oxybate were nausea, enuresis, vomiting, headache, weight decreased, decreased appetite, dizziness, and sleepwalking ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Avadel CNS Pharmaceuticals, LLC at 1-888-828-2335 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Use in specific populations

Sourced from openFDA

• Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ). • Geriatric patients: Monitor for impaired motor and/or cognitive function when taking LUMRYZ ( 8.5 ). • Hepatic Impairment: Because of an increase in exposure, LUMRYZ should not be initiated in patients with hepatic impairment because appropriate dosage adjustments for initiation of LUMRYZ cannot be made ( 8.6 ). 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. Oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Labor or Delivery LUMRYZ has not been studied in labor or delivery.

Overdosage

Sourced from openFDA

10.1 Human Experience Information regarding overdose with LUMRYZ is derived largely from reports in the medical literature that describe symptoms and signs in individuals who have ingested GHB illicitly. In these circumstances, the co-ingestion of other drugs and alcohol was common and may have influenced the presentation and severity of clinical manifestations of overdose. In adult clinical trials of immediate-release sodium oxybate, two cases of overdose with sodium oxybate were reported. In the first case, an estimated dose of 150 g, more than 15 times the maximum recommended dose, caused a patient to be unresponsive with brief periods of apnea and to be incontinent of urine and feces. This individual recovered without sequelae. In the second case, death was reported following a multiple drug overdose consisting of sodium oxybate and numerous other drugs. 10.2 Signs and Symptoms Information about signs and symptoms associated with overdosage with LUMRYZ derives from reports of illicit use of GHB. Patient presentation following overdose is influenced by the dose ingested, the time since ingestion, the co-ingestion of other drugs and alcohol, and the fed or fasted state.

Approval history

Sourced from openFDA
  • Jul 17, 2002NDANDA021196Jazz Pharms
  • May 1, 2023NDANDA214755Avadel Cns
  • Sep 10, 2025ANDAANDA203631Amneal
  • Nov 5, 2025ANDAANDA210523Ascent Pharms Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
65,315 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea4,9047.5%
  2. 2Anxiety3,9556.1%
  3. 3Somnolence3,9356.0%
  4. 4Insomnia3,3465.1%
  5. 5Feeling Abnormal3,2094.9%
  6. 6Headache3,1914.9%
  7. 7Fatigue3,1874.9%
  8. 8Depression3,1604.8%
  9. 9Dizziness2,9524.5%
  10. 10Weight Decreased2,8834.4%
  11. 11Condition Aggravated2,8024.3%
  12. 12Drug Ineffective2,6224.0%
  13. 13Sleep Apnoea Syndrome2,5793.9%
  14. 14Fall2,5743.9%
  15. 15Unevaluable Event2,3783.6%

Literature

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Recent PubMed references pinned to Oxybate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 63 ClinicalTrials.gov registrations naming Oxybate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Oxybate work?
Mechanism-of-action classes: GABA B Agonists; Unknown Cellular or Molecular Interaction.
What is Oxybate used for?
According to FDA labeling, Oxybate carries indications including: LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. LUMRYZ is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Oxybate?
Oxybate is classified as Central Nervous System Depressant, GABA B Agonists, Unknown Cellular or Molecular Interaction, Central Nervous System Depression, Decreased Central Nervous System Organized Electrical Activity, Decreased Organized Electrical Activity.
What are the brand names for Oxybate?
Oxybate is marketed under brand names including Lumryz, Xyrem, Xywav.
What are the contraindications for Oxybate?
Oxybate labeling lists contraindications including: LUMRYZ is contraindicated for use in: ● combination with sedative hypnotics [see Warnings and Precautions (5.1) ] ● combination with alcohol [see Warnings and Precautions (5.1) ] ● patients with succinic semialdehyde dehydrogenase deficiency [see Clinical Pharmacology (12.3) ] • In combination with sedative hypnotics or alcohol ( 4 ). • Succinic semialdehyde dehydrogenase deficiency ( 4 ).. Always consult the full prescribing information and a clinician.
Note. Data for oxybate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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