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Sodium Oxybate (Monograph)

Brand name: Xyrem
Drug class: Central Nervous System Agents, Miscellaneous
VA class: CN900
Chemical name: 4-hydroxy-butanoic acid sodium salt
Molecular formula: C4H7NaO3
CAS number: 502-85-2

Medically reviewed by on Mar 27, 2024. Written by ASHP.


Risk Evaluation and Mitigation Strategy (REMS):

FDA approved a REMS for sodium oxybate to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of sodium oxybate and consists of the following: medication guide, elements to assure safe use, and implementation system. See


    Abuse Potential
  • A known drug of abuse. (See Misuse and Abuse Potential under Cautions.)

  • Abuse of illicit forms of sodium oxybate (γ-hydroxybutyrate [GHB]), alone or in combination with other CNS depressants, associated with serious adverse CNS effects, including seizures, respiratory depression, decreases in level of consciousness, coma, and death.

    Adverse CNS and Respiratory Effects
  • CNS depressant. Obtundation and respiratory depression reported in clinical trials at recommended dosages. Most patients with narcolepsy were receiving a CNS stimulant concomitantly. (See CNS Depression and also see Respiratory Effects under Cautions.)

    Restricted Distribution Program
  • Because of risks of CNS depression, abuse, and misuse, available only through the Xyrem Success Program from a centralized pharmacy.

  • Prescribers and patients must enroll in the program (866-997-3688 or [Web]).


CNS depressant that exhibits anticataplectic and potent hypnotic activity.

Uses for Sodium Oxybate


Management of excessive daytime sleepiness and/or cataplexy in patients with narcolepsy.

Sodium Oxybate Dosage and Administration



Oral Administration

Administer orally in 2 equally divided doses daily. Administer at least 2 hours after eating.

Dilute each dose with approximately 60 mL of water in the child-resistant vial provided by pharmacy. Prepare both doses before bedtime.

Take first dose at bedtime and second dose 2.5–4 hours later (while sitting in bed).

May need to set alarm clock to awaken for second dose; place second dose in close proximity to bed.

Lie down and remain in bed after each dose.




Initially, 4.5 g nightly in 2 doses of 2.25 g each. Increase dosage in increments of 1.5 g daily (0.75 g per dose) at 1-week intervals to a maximum dosage of 9 g daily.

Prescribing Limits



Maximum 9 g daily.

Special Populations

Hepatic Impairment

Initially, 2.25 g nightly in 2 doses of approximately 1.13 g each.

Renal Impairment

Specific dosage recommendation not available.

Geriatric Patients

Select dosage with caution, usually starting at lower end of dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Cautions for Sodium Oxybate




CNS Depression

Obtundation and respiratory depression reported at recommended dosages in clinical trials. (See Respiratory Effects under Cautions and see Advice to Patients.)

Concomitant use with other CNS depressants may increase risk of respiratory depression, hypotension, profound sedation, syncope, and death. (See Specific Drugs under Interactions.)

Deaths reported, although cause of death sometimes indeterminable. Confounding factors have included underlying conditions that may predispose to CNS and respiratory depression (e.g., sleep apnea, COPD), preexisting psychiatric disorders (e.g., depression, substance abuse), use for off-label indications, use of excessive or rapidly titrated dosages, and concomitant use of alcohol or other CNS depressant(s).

Monitor patients for events related to CNS depression upon initiation of therapy and periodically thereafter.

Respiratory Effects

Respiratory drive may be impaired, especially in patients with preexisting respiratory impairment. Life-threatening respiratory depression reported with overdosage. Respiratory depression and an increase in obstructive sleep apnea reported in clinical trials. Increased central sleep apnea and oxygen desaturation reported in patients with obstructive sleep apnea.

Use with caution, if at all, in patients with respiratory impairment (e.g., sleep apnea, COPD). Be aware that sleep-related breathing disorders tend to be more prevalent in obese patients and in postmenopausal women not receiving hormone replacement therapy as well as in patients with narcolepsy.

Misuse and Abuse Potential

Severe dependence and craving reported following illicit use at dosages similar to those used in clinical trials. Potential for misuse and abuse. (See Boxed Warning and see Preparations.)

Carefully evaluate patients with history of drug abuse and closely monitor for signs of misuse or abuse (e.g., dosage escalation, drug-seeking behavior, feigned cataplexy).

Other Warnings/Precautions

Behavioral and Psychiatric Effects

Confusion (dose related), depression, and other neuropsychiatric events (e.g., psychosis, paranoia, hallucinations, agitation, anxiety) reported at recommended dosages. Suicide or attempted suicide reported in narcolepsy clinical trials in 4 patients; 3 had history of depressive disorder.

Immediately and carefully evaluate patients who become confused or depressed or who experience thought disorders and/or behavioral abnormalities. Carefully monitor patients with history of mental depression or suicide attempt for emergence of depressive symptoms. Carefully monitor patients with new or worsening anxiety.


Confused behavior at night, sometimes associated with wandering (sleepwalking), has occurred. Substantial injury or potential injury associated with sleepwalking reported rarely. Evaluate these episodes and consider appropriate interventions.

Sodium Content

Each gram of sodium oxybate contains approximately 7.9 mEq (182 mg) of sodium. Consider sodium content in patients with heart failure, hypertension, or renal impairment.

Specific Populations


Category C.


Not known whether distributed into milk; caution advised.

Pediatric Use

Safety and efficacy not established in pediatric patients.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution. Higher incidence of headaches reported in geriatric patients compared with younger adults in clinical studies in patients with disorders other than narcolepsy.

Monitor geriatric patients for impaired motor and cognitive function.

Hepatic Impairment

Elimination half-life and systemic exposure increased; dosage adjustment recommended. (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Not studied in patients with renal impairment.

Consider sodium content. (See Sodium Content under Cautions.)

Common Adverse Effects

Nausea, dizziness, vomiting, somnolence, enuresis, tremor.

Drug Interactions

Does not inhibit CYP1A2, 2C9, 2C19, 2D6, 2E1, or 3A.

Specific Drugs




CNS depressants

Possible respiratory depression and marked impairment of consciousness

Concomitant use with sedative-hypnotic agents or alcohol contraindicated

Concomitant use with other CNS depressants not recommended; if required, consider dosage reduction or discontinuance of one or more CNS depressants (including sodium oxybate)

Consider interrupting sodium oxybate therapy during short-term (e.g., perioperative, postoperative) opiate use


Pharmacokinetic or pharmacodynamic interaction unlikely


Pharmacokinetic interaction unlikely

Pharmacodynamic interaction cannot be ruled out


Pharmacokinetic interaction unlikely

Pharmacodynamic interaction cannot be ruled out


Change in sodium oxybate pharmacokinetics due to alterations in gastric pH unlikely


Pharmacokinetic interaction unlikely

Pharmacodynamic interaction cannot be ruled out


Pharmacokinetic interaction unlikely

Pharmacodynamic interaction cannot be ruled out

Sodium Oxybate Pharmacokinetics



Rapidly absorbed; peak plasma concentrations attained within 0.5–1.25 hours.

Absolute bioavailability is approximately 88%.

Nonlinear pharmacokinetics; plasma concentrations increase 3.7-fold as dose is doubled from 4.5 to 9 g.


High-fat meal delays time to peak plasma concentrations (to 2 hours) and reduces peak plasma concentrations by 59% and AUC by 37%.

Special Populations

AUC values increased 100% in patients with cirrhosis.


Plasma Protein Binding




Metabolized to carbon dioxide and water.

Elimination Route

Carbon dioxide eliminated by expiration. Fecal excretion negligible; <5% excreted in urine as unchanged drug.


0.5–1 hour.

Special Populations

Half-life increased in patients with cirrhosis; dosage adjustment recommended in patients with hepatic impairment. (See Hepatic Impairment under Dosage and Administration.)

Not studied in patients with renal impairment.

Pharmacokinetic profile in individuals 65–75 years of age similar to that in younger adults (48–64 years of age).




Oral Solution

25°C (may be exposed to 15–30°C).


Advice to Patients


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Commercially available sodium oxybate oral solution is subject to control under the Federal Controlled Substances Act of 1970 as a schedule III (C-III) drug. The active ingredient, sodium oxybate (also called GHB) is subject to control as a schedule I (C-I) drug. Nonmedical uses of the commercially available preparation also are subject to control as a schedule I (C-I) drug.

Distribution is restricted. (See Boxed Warning.)

Sodium Oxybate


Dosage Forms


Brand Names



For solution, concentrate

500 mg/mL

Xyrem (C-III; available with press-in bottle adapter, 10-mL measuring syringe, and two 90-mL pharmacy vials)

Jazz Pharmaceuticals

AHFS DI Essentials™. © Copyright 2024, Selected Revisions April 6, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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