Sodium Oxybate(soe’ dee um)
Xyrem
PREGNANCY CATEGORY B
CONTROLLED SUBSTANCE C-III
Drug Classes
Anticataplectic
CNS depressant
Therapeutic Actions
CNS depressant, its mechanism of action in affecting cataplexy is not understood.
Indications
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Treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy
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Unlabeled uses: Fibromyalgia pain, fatigue
Contraindications and Cautions
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Contraindicated with hypersensitivity to any component of the drug, succinic semialdehyde dehydrogenase deficiency, concomitant treatment with sedative-hypnotics.
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Use cautiously with respiratory dysfunction, depression, pregnancy, lactation.
Available Forms
Solution—500 mg/mL
Dosages
Adults
4.5 g/day PO divided into two equal doses of 2.25 g. Administer drug at bedtime and again 2.5–4 hr later. Doses may be increased no more than every 1–2 wk to a maximum of 9 g/day in increments of 1.5 g/day (0.75 g dose). Usual range, 6–9 g night.
Pediatric patients younger than 16 yr
Safety and efficacy not established.
Patients with hepatic impairment
Reduce initial dose by half, and adjust dosage to effect while watching closely for adverse reactions.
Pharmacokinetics
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