• Treatment of cataplexy in patients with narcolepsy (generally with concurrent stimulant therapy).

Contraindicated in:

• Concurrent alcohol, CNS depressant or sedative/hypnotic therapy.

Use Cautiously in:

• Hepatic impairment (↓ starting dose by 50%)
• Patients with hypertension, HF or renal impairment (contains 1.6 g sodium/9 g sodium oxybate)
• History of depression or suicidal attempt
• OB: Pregnancy (use only if clearly needed)
• Lactation: Pedi: Lactation or children (safety not established).

CNS: SEIZURES, SUICIDAL THOUGHTS, dizziness, headache, somnolence, abnormal dreams, aggression, agitation, anxiety, confusion, depression, hallucinations, insomnia, nervousness, paranoia, psychosis, weakness.

Resp: RESPIRATORY DEPRESSION.

GI: nausea, abdominal pain, dyspepsia, vomiting.

GU: urinary incontinence.

MS: arthritis, myalgia.

Misc: pain, hyperhidrosis.

Drug-Drug:

• ↑CNS depression with other CNS depressants including alcohol and sedative/hypnotics (concurrent use is contraindicated).
• Valproic acid may ↑ levels; ↓ dose of sodium oxybate by at least 20% when starting valproic acid; use lower starting dose of sodium oxybate when initiating therapy in patient already receiving valproic acid,

(Generic available)

• Oral solution : 500 mg/mL;

• PO (Adults): 2.25 g at bedtime, repeated 2.5–4 hr later (total daily dose 4.5g), may be ↑ at 2–wk intervals by 1.5 g/d (0.75 g/dose) up to 9 g/day.

Xyrem, gamma hydroxybutyrate (GHB)

• Sodium oxybate is a CNS depressant. Its mechanism of action as an anticataplectic is not known.

• Decreased incidence of cataplexy episodes in patients with narcolepsy.

Therapeutic Classification: anticataplectic

Pharmacologic Classification: hydroxybutyrate

Absorption: Rapidly but incompletely absorbed (25%) following oral administration; absorption is delayed and decreased by a high fat meal.

Distribution: Unknown.

Metabolism/Excretion: Undergoes significant first-pass hepatic metabolism. Almost entirely biotransformed to carbon dioxide which is eliminated by expiration; <5% excreted unchanged in urine.

Half-life: 30–60 min.

Schedule III (C-III)

(CNS effects)

• Prescribers must document that patients have read the Sodium Oxybate REMS Program or the Xyrem REMS Program educational materials and enrolled in the program before the first prescription will be filled. Review materials with each refill in case of new information. Materials are distributed by a single centralized pharmacy.
• Instruct patient to mix and take sodium oxybate on an empty stomach exactly as directed. Medication causes sleep very quickly; advise patients to take only at bedtime while in bed. Time between food and dose should remain consistent. Instruct patient to lie down and sleep after each dose and not to take sodium oxybate at any other time than at night, immediately before bedtime and 2.5–4 hr later. Advise patient to set an alarm clock to wake and take the second dose. If the second dose is missed, skip dose and do not take again until next night. Never take 2 doses at once.
• If more than prescribed dose is taken or if taken by accident, get emergency help immediately. Keep out of reach of children.
• Caution patient to avoid driving and other activities requiring alertness for 6 hr after taking sodium oxybate. Caution should continue during the next day until response to medication is known.
• Inform patient of potential adverse reactions. May cause urinary incontinence. Notify health care professional if incontinence, snoring, trouble breathing during sleep, confusion, abnormal thinking, depression, loss of consciousness, sleepwalking, increased sleepiness during the day occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Caution patient to avoid alcohol or other CNS depressants while taking sodium oxybate.
• Advise female patients to notify health care professional if pregnancy is planned or expected or if breastfeeding.
• Emphasize the importance of frequent monitoring by prescriber. A detailed account of adverse reactions experienced by the patient will be taken.

SOE-dee-um OX-ee-bate

NDC Code^*

• 68727- Jazz Pharmaceuticals, Inc.
  • 68727-100- Xyrem
    • 68727-100-01- 180 mL in 1 BOTTLE, PLASTIC (68727-100-01)