Monograph Details
|
|
Central Nervous System
> ADHD/narcolepsy
|
|
XYREM |
| Manufacturer |
|
Jazz Pharmaceuticals |
| Legal Classification |
|
CIII |
| Pharmacological Class |
|
Antinarcoleptic (CNS depressant). |
| Generic Name |
|
Sodium oxybate 500mg/mL; soln; contains sodium 91mg/mL. |
| Indications |
|
Excessive daytime sleepiness and cataplexy associated with narcolepsy. |
| Children |
|
<16yrs: not recommended. |
| Adults |
|
≥16yrs: Take on empty stomach. Dilute each dose with 2 oz of water. Initially 4.5g/night in two equally divided doses, at bedtime then again 2.5–4 hours later. May increase by 1.5g/night (0.75g/dose) at 1–2 week intervals; usual range: 6–9g/night; max 9g/night. Allow 6 hours before becoming active after last dose. Consider concomitant CNS stimulant use (see literature). Hepatic impairment: reduce dose by ½, titrate and monitor closely. |
| Contraindications |
|
Concomitant sedative hypnotics. Succinic semialdehyde dehydrogenase deficiency. |
| Precautions |
|
History of depression or suicidal ideation (monitor). Respiratory dysfunction. Consider sodium intake with heart failure, hypertension, renal insufficiency (see literature). Hepatic impairment. Drug abusers. Reevaluate every 3 months. Elderly. Labor & delivery. Pregnancy (Cat.B). Nursing mothers. |
| Interactions |
|
See Contraindications. CNS depression potentiated by alcohol, other CNS depressants. |
| Adverse Reactions |
|
Headache, GI upset, dizziness, nasopharyngitis, somnolence, urinary incontinence, respiratory depression, confusion, sleepwalking, depressive symptoms, thought disorders, behavior abnormalities. |
| Extra Text |
|
Note: Only available through the Xyrem Success Program. For more information call (866) 997-3688. |
| How Supplied |
|
Soln—180mL (w. oral dispensing syringe) |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
