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Xyrem Generic Name & Formulations
Legal Class
CIII
General Description
Sodium oxybate 500mg/mL; soln.
Pharmacological Class
Antinarcoleptic (CNS depressant).
How Supplied
Soln—180mL (w. oral measuring syringe)
Manufacturer
Generic Availability
NO
Xyrem Indications
Indications
Cataplexy or excessive daytime sleepiness in patients ≥7yrs of age with narcolepsy.
Xyrem Dosage and Administration
Adult
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: initially ½ of original dose per night, given in two equally divided doses. Concomitant divalproex sodium: reduce initial Xyrem dose by at least 20%; if already taking divalproex sodium, start Xyrem at lower dose; monitor, adjust accordingly.
Children
<7yrs: not established. Take on empty stomach. Dilute each dose with 60mL of water. ≥7yrs (<20kg): see full labeling. (20–<30kg): initially ≤2g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1g/night (0.5g/dose) at weekly intervals. Max total dose: 6g/night. (30–<45kg): initially ≤3g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1g/night (0.5g/dose) at weekly intervals. Max total dose: 7.5g/night. (≥45kg): 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. Max total dose: 9g/night. Some patients may respond better with unequal doses. Allow 6hrs before becoming active after last dose. Consider concomitant CNS stimulant use (see full labeling). Hepatic impairment: initially ½ of original dose per night, given in two equally divided doses. Concomitant divalproex sodium: reduce initial Xyrem dose by at least 20%; if already taking divalproex sodium, start Xyrem at lower dose; monitor, adjust accordingly.
Xyrem Contraindications
Contraindications
Concomitant sedative hypnotics or alcohol. Succinic semialdehyde dehydrogenase deficiency.
Xyrem Boxed Warnings
Boxed Warning
CNS depression. Abuse and misuse.
Xyrem Warnings/Precautions
Warnings/Precautions
Risk of CNS depression. Abuse potential (monitor). Respiratory dysfunction. Sleep-related breathing disorders (esp. in men, postmenopausal women not on HRT, obese, or narcolepsy patients). History of depression or suicidal ideation (monitor). Consider sodium intake with heart failure, hypertension, renal insufficiency (see full labeling). Parasomnias. Hepatic impairment. Drug abusers. Elderly. Labor & delivery. Pregnancy. Nursing mothers.
REMS
Xyrem Pharmacokinetics
See Literature
Xyrem Interactions
Interactions
See Contraindications. CNS depression potentiated by concomitant other CNS depressants (eg, opioids, benzodiazepines, antidepressants, antipsychotics, general anesthetics, muscle relaxants, sedating antiepileptic drugs). Potentiated by divalproex sodium.
Xyrem Adverse Reactions
Adverse Reactions
Nausea, dizziness, vomiting, somnolence, enuresis, tremor; children also: headache, weight decreased, decreased appetite; CNS and respiratory depression, sleep-disordered breathing, sleepwalking, depressive symptoms, confusion, anxiety, other behavioral/psychiatric reactions.
Xyrem Clinical Trials
See Literature
Xyrem Note
Notes
Only available through the Xyrem REMS Program. For more information call (866) 997-3688.
Xyrem Patient Counseling
See Literature
