sodium oxybate

Contraindicated in:

Concurrent alcohol, CNS depressant, or sedative/hypnotic therapy;
Succinic semialdehyde dehydrogenase deficiency;
Hepatic impairment (Lumryz only).

Use Cautiously in:

Hepatic impairment (↓ starting dose of Xyrem by 50%);
Patients with hypertension, HF, or renal impairment (contains 1.6 g sodium/9 g sodium oxybate);
History of depression or suicidal attempt;
Obstructive sleep apnea;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children <7 yr (Lumryz) or < 7 yr or <20 kg (Xyrem).

Adv. Reactions/Side Effects ⬆ ⬇

Derm: ↑sweating

GI: nausea, vomiting, abdominal pain, dyspepsia

GU: urinary incontinence

MS: arthritis, myalgia

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

Resp: RESPIRATORY DEPRESSION

Interactions ⬆ ⬇

Drug-drug:

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

Availability ⬆ ⬇

(Generic available)

Immediate-release oral solution (Xyrem): 500 mg/mL
Extended-release oral suspension (Lumryz): 4.5 g/pkt; 6 g/pkt; 7.5 g/pkt; 9 g/pkt

Route/Dosage ⬆ ⬇

Xyrem

PO (Adults and Children ≥7 yr and ≥45 kg): 2.25 g at bedtime, repeated 2.5–4 hr later (total nightly dose = 4.5 g); may ↑ at weekly intervals by 1.5 g/night (0.75 g/dose) (max dose = 9 g/night).
PO (Children ≥7 yr and 30–44.9 kg): 1.5 g at bedtime, repeated 2.5–4 hr later (total nightly dose = 3 g); may ↑ at weekly intervals by 1 g/night (0.5 g/dose) (max dose = 7.5 g/night).
PO (Children ≥7 yr and 20–29.9 kg): 1 g at bedtime, repeated 2.5–4 hr later (total nightly dose = 2 g); may ↑ at weekly intervals by 1 g/night (0.5 g/dose) (max dose = 6 g/night).

Hepatic Impairment

PO (Adults and Children ≥7 yr and ≥45 kg): ↓starting dose by 50% (1.12 g at bedtime, repeated 2.5–4 hr later) (total nightly dose = 2.25 g); dose increments should be titrated to desired effect with close monitoring.

Hepatic Impairment

PO (Children ≥7 yr and 30–44.9 kg): ↓starting dose by 50% (0.75 g at bedtime, repeated 2.5–4 hr later) (total nightly dose = 1.5 g); dose increments should be titrated to desired effect with close monitoring.

Hepatic Impairment

PO (Children ≥7 yr and 20–29.9 kg): ↓starting dose by 50% (0.5 g at bedtime, repeated 2.5–4 hr later) (total nightly dose = 1 g); dose increments should be titrated to desired effect with close monitoring.

Lumryz

PO (Adults ): 4.5 g once nightly at bedtime; may ↑ at weekly intervals by 1.5 g/night (max dose = 9 g/night).
PO (Children ≥7 yr and ≥45 kg): 4.5 g once nightly at bedtime; may ↑ at weekly intervals by 1.5 g/night (max dose = 9 g/night).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Sodium oxybate is a CNS depressant and the sodium salt of gamma hydroxybutyrate, a metabolite of GABA. Its mechanism of action as an anticataplectic is not known.

Therapeutic effects:

Decreased incidence of cataplexy episodes in patients with narcolepsy.

Classifications ⬆ ⬇

Therapeutic Classification: anticataplectic

Pharmacologic Classification: hydroxybutyrate

Pharmacokinetics ⬆ ⬇

Absorption: Rapidly but incompletely absorbed (25%) following oral administration; absorption is delayed and ↓ 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.

Contr. Subst. Schedule ⬆ ⬇

Schedule III (C-III)

Time/Action Profile ⬆ ⬇

(CNS effects)

ROUTE	ONSET	PEAK	DURATION
PO (Xyrem)	rapid	0.5–1 hr	6 hr
PO (Lumryz)	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

REMS: Prescribers must document that patients have read the Xywav and Xyrem REMS Program or Lumryz 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 (Xyrem only). Advise patient to set an alarm clock to wake and take the 2nd dose (Xyrem only). If the 2nd dose is missed, skip dose and do not take again until next night (Xyrem only). Never take two 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.
Advise patient that sodium oxybate is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed. Store in a location not accessible by others.
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, loss of consciousness, sleepwalking, or ↑ daytime sleepiness occur.
Caution patient and family that sodium oxybate may cause depression, suicidal ideation, or suicide. Notify health care professional immediately if depressive symptoms 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.
Rep: Advise women of reproductive potential 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.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Contr. Subst. Schedule ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆