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 2oz 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.
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 (Cat.C). Nursing mothers.
See Contraindications. CNS depression potentiated by other CNS depressants (eg, opioids, benzodiazepine, antidepressants, antipsychotics, general anesthetics, muscle relaxants). Potentiated by divalproex sodium.
Antinarcoleptic (CNS depressant).
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)