Home Drug Guide Sodium Oxybate

Drug Guide

Generic Name

Sodium Oxybate

Brand Names Xyrem, Lumryz

Classification

Therapeutic: Central Nervous System depressant, treatment of narcolepsy and cataplexy

Pharmacological: GABA_B receptor agonist

FDA Approved Indications

Narcolepsy (with or without cataplexy)
Cataplexy (approved in specific formulations)

Mechanism of Action

Sodium oxybate is a pharmacologically active metabolite of gamma-hydroxybutyrate (GHB) which acts on GABA_B receptors and other neurotransmitter systems to promote sleep and reduce cataplexy episodes, though its precise mechanism is not fully understood.

Dosage and Administration

Adult: Xyrem: The initial dose is typically 4.5 g/night divided into two doses, titrated up to a maximum of 9 g/night. Lumryz is a once-night dose. Doses are taken on an empty stomach at bedtime.

Pediatric: Use not established for pediatric patients.

Geriatric: Use with caution; start at lower doses and monitor closely.

Renal Impairment: Dose reduction may be necessary; consult specific guidelines.

Hepatic Impairment: Use with caution; no specific dose adjustment recommended but monitor closely.

Pharmacokinetics

Absorption: Rapid absorption after oral administration.

Distribution: Widely distributed, crosses blood-brain barrier.

Metabolism: Metabolized in the liver; exact pathways not fully elucidated.

Excretion: Excreted primarily in urine.

Half Life: Approximately 30-60 minutes.

Contraindications

History of substance abuse, including GHB or alcohol dependence.
History of respiratory depression or untreated obstructive sleep apnea.

Precautions

Use with caution in patients with hepatic or renal impairment.
Monitor closely for CNS depression and respiratory issues.

Adverse Reactions - Common

Nausea (Common)
Dizziness (Common)
Somnolence (Common)
Sleep paralysis (Less common)

Adverse Reactions - Serious

Respiratory depression (Rare)
Seizures (at overdose or with abrupt withdrawal) (Rare)
Psychiatric disturbances (e.g., confusion, agitation) (Less common)

Drug-Drug Interactions

Central nervous system depressants (e.g., opioids, benzodiazepines, alcohol) increase CNS depression risk.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor sleep patterns, respiratory status, behavioral changes, and signs of overdose or withdrawal.

Diagnoses:

Risk for respiratory depression
Risk for substance dependence

Implementation: Administer dose as prescribed, typically at bedtime; monitor vital signs and mental status.

Evaluation: Assess therapeutic response in terms of reduction in narcolepsy symptoms and adverse effects.

Patient/Family Teaching

Take exactly as prescribed, on an empty stomach before sleep.
Warn about the risk of CNS depression and respiratory depression, particularly when combined with other depressants.
Inform about potential for sleep-related behaviors such as sleepwalking or sleep-driving.

Special Considerations

Black Box Warnings:

Potential for severe respiratory depression, coma, and seizures, especially if misused or combined with other CNS depressants.
Risk of abuse and dependence.
Risks associated with abrupt cessation.

Genetic Factors: Pharmacogenetic factors affecting metabolism are not well established.

Lab Test Interference: May interfere with urine drug screens and lead to false-positive results for GHB.

Overdose Management

Signs/Symptoms: Loss of consciousness, seizures, respiratory depression, coma.

Treatment: Supportive care, maintain airway, establish IV access, monitor vital signs, consider activated charcoal if ingestion is recent, and provide respiratory support as needed.

Storage and Handling

Storage: Store at room temperature, away from moisture, heat, and light.

Stability: Stable until expiration when stored properly.