Generic Name and Formulations:
Sodium oxybate 500mg/mL; soln; contains sodium 91mg/mL.
Jazz Pharmaceuticals plc
Indications for XYREM:
Excessive daytime sleepiness and cataplexy associated with narcolepsy.
Take on empty stomach. Dilute each dose with 60mL of water. Initially 4.5g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1.5g/night (0.75g/dose) at weekly intervals; usual range: 6–9g/night; max 9g/night. Allow 6hrs before becoming active after last dose. Consider concomitant CNS stimulant use (see full labeling). Hepatic impairment: reduce dose by ½, titrate and monitor closely. Concomitant divalproex sodium: reduce initial Xyrem dose by at least 20%; if already taking divalproex sodium, start Xyrem at lower dose; monitor, adjust accordingly.
Concomitant sedative hypnotics or alcohol. Succinic semialdehyde dehydrogenase deficiency.
CNS depression. Misuse and abuse.
Risk of CNS depression. Abuse potential (monitor). Respiratory dysfunction. History of depression or suicidal ideation (monitor). Consider sodium intake with heart failure, hypertension, renal insufficiency (see full labeling). Hepatic impairment. Drug abusers. Reevaluate every 3 months. Elderly. Labor & delivery. Pregnancy. Nursing mothers.
Antinarcoleptic (CNS depressant).
See Contraindications. CNS depression potentiated by concomitant other CNS depressants (eg, opioids, benzodiazepine, antidepressants, antipsychotics, general anesthetics, muscle relaxants). Potentiated by divalproex sodium.
Nausea, dizziness, vomiting, somnolence, enuresis, tremor; CNS and respiratory depression, sleepwalking, depressive symptoms, confusion, anxiety, other neuropsychiatric reactions.
Only available through the Xyrem REMS Program. For more information call (866) 997-3688.
Soln—180mL (w. oral dispensing syringe)
Endocrinology Advisor Articles
- Relationship Between HbA1c and Coronary Artery Disease
- DPP-4 Inhibitors and Incidence of Rheumatoid Arthritis in Type 2 Diabetes
- Cost-Benefit Analysis of Insulin Analogs in Type 2 Diabetes
- Nonfunctioning Adrenal Incidentaloma Associated With Metabolic Syndrome
- Cushing Syndrome Results in Poor Quality of Life Even After Remission
- Low Predictive Power of Biomarkers for Estimated Glomerular Filtration Rate Decline
- FDA to Review Gimoti for Diabetic Gastroparesis in Adult Women
- FDA Approves First Mobile App for Use in Preventing Pregnancy
- Hypothyroidism Predicts Atrial Tachyarrhythmia After AF Catheter Ablation
- Treating Painful Diabetic Peripheral Neuropathy With Electroacupuncture