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sodium oxybate (Rx)Brand and Other Names:Xyrem, oxybate sodium

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral solution

  • 500mg/mL
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Narcolepsy

Indicated for treatment of cataplexy in narcolepsy; also indicated for excessive daytime sleepiness in narcolepsy

Initial: 4.5 g/day, divided HS and 2.5-4 hr later

Increase dose by 1.5 g per night at weekly intervals (additional 0.75 g at bedtime and 0.75 g taken 2.5 to 4 hr later) to the effective dose range of 6-9 g/night PO; not to exceed 9 g/night

Dosage Modifications

Hepatic impairment: Decrease initial dose by 50% and titrate slowly to response; elimination half-life is significantly increased

Renal impairment: No dose adjustment necessary

Coadministration with divalproex sodium

  • Patients already stabilized on sodium oxybate: Decrease night dose of sodium oxybate by at least 20% when starting divalproex sodium
  • Patients already taking divalproex sodium: Use a lower starting sodium oxybate dose; monitor dose and adjust dose accordingly

Dosing Considerations

Contains high sodium content

3 g/night: 550 mg sodium

4.5 g/night: 820 mg sodium

6 g/night: 1100 mg sodium

7.5 g/night: 1400 mg sodium

9 g/night: 1640 mg sodium

Administration

Dilute each dose in 2 oz (60 mL) water

Avoid food for at least 2 hr before dose

Take both doses of sodium oxybate while in bed and lie down immediately after dosing

Sodium oxybate may cause patients to fall asleep abruptly without first feeling drowsy

Patients will often fall asleep within 5 minutes of dose, and will usually fall asleep within 15 minutes

Patients should remain in bed following ingestion of the first and second doses, and should not take the second dose until 2.5-4 hr after the first dose

Patients may need to set an alarm to awaken for the second dose

Dosage Forms & Strengths

oral solution

  • 500mg/mL
more...

Narcolepsy

Indicated for treatment of cataplexy in narcolepsy; also indicated for excessive daytime sleepiness in narcolepsy

<16 years: Safety and efficacy not established

≥16 years

  • Initial: 4.5 g/day, divided HS and 2.5-4 hr later
  • Increase dose by 1.5 g per night at weekly intervals (additional 0.75 g at bedtime and 0.75 g taken 2.5 to 4 hr later) to the effective dose range of 6-9 g/night PO; not to exceed 9 g/night

Dosage Modifications

Hepatic impairment: Decrease initial dose by 50% and titrate slowly to response; elimination half-life is significantly increased

Renal impairment: No dose adjustment necessary

Coadministration with divalproex sodium

  • Patients already stabilized on sodium oxybate: Decrease night dose of sodium oxybate by at least 20% when starting divalproex sodium
  • Patients already taking divalproex sodium: Use a lower starting sodium oxybate dose; monitor dose and adjust dose accordingly

Dosing Considerations

Contains high sodium content

3 g/night: 550 mg sodium

4.5 g/night: 820 mg sodium

6 g/night: 1100 mg sodium

7.5 g/night: 1400 mg sodium

9 g/night: 1640 mg sodium

Administration

Dilute each dose in 2 oz (60 mL) water

Avoid food for at least 2 hr before dose

Take both doses of sodium oxybate while in bed and lie down immediately after dosing

Sodium oxybate may cause patients to fall asleep abruptly without first feeling drowsy

Patients will often fall asleep within 5 minutes of dose, and will usually fall asleep within 15 minutes

Patients should remain in bed following ingestion of the first and second doses, and should not take the second dose until 2.5-4 hr after the first dose

Patients may need to set an alarm to awaken for the second dose

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Interactions

Interaction Checker

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    Contraindicated

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        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Headache (20-25%)

            Nausea (20-25%)

            Dizziness (10-19%)

            Pain (10-19%)

            Somnolence (10-19%)

            Pharyngitis (10-19%)

            Infection (10-19%)

            1-10%

            Flu syndrome (5-9%)

            Accidental injury (5-9%)

            Diarrhea (5-9%)

            Sporadic urinary incontinence (5-9%)

            Vomiting (5-9%)

            Rhinitis (5-9%)

            Asthenia (5-9%)

            Sinusitis (5-9%)

            Nervousness (5-9%)

            Back pain (5-9%)

            Confusion (5-9%)

            Sleepwalking (5-9%)

            Depression (5-9%)

            Dyspepsia (5-9%)

            Abd pain (5-9%)

            Abnormal dreams (5-9%)

            Insomnia (5-9%)

            <1%

            Psychosis

            Paranoia

            Hallucinations

            Agitation

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            Warnings

            Black Box Warnings

            Sodium oxybate (GHB) is a known drug of abuse; abuse has been associated with CNS adverse events, including seizures, respiratory depression, profound decreases in level of consciousness, coma, and death

            Even at recommended doses, use has been associated with confusion, depression, and other neuropsychiatric events

            Reports of respiratory depression occurred in clinical trials' almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants

            Only available through the Xyrem Success Program, which uses a centralized pharmacy at the phone number 1- 866-XYREM88 (1-866-997-3688); the Success Program provides educational materials to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form

            Once documented that the patient has read and/or understood the materials, the drug will be shipped to the patient; the program also recommends patient follow-up every 3 months

            Physicians are expected to report all serious adverse events to the manufacturer

            Contraindications

            Hypersensitivity

            Concomitant sedative-hypnotic drugs or other drugs used for insomnia

            Coadministration with alcohol

            Succinic semialdehyde dehydrogenase deficiency

            Cautions

            Schedule III agent; available only through the Xyrem Success Program, 1-866-997-3688

            Abuse can be fatal

            Risks of: depression, respiratory depression, confusion, neuropsychiatric events

            Only take at bedtime; do not operate machinery for at least 6 hr after dose

            Use with caution in patients with sleep apnea

            Do not drink alcoholic beverages (see Contraindications)

            Product has high salt content; caution in patients who are sensitive to salt intake (eg, heart failure, hypertension, renal impairment)

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown if distributed in human breast milk; caution advised

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            CNS depressant; sodium oxybate is the sodium salt of gamma hydroxybutyrate, an endogenous compound and metabolite of the neurotransmitter GABA

            It is hypothesized that the therapeutic effects on cataplexy and excessive daytime sleepiness are mediated through GABAB actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons

            Absorption

            Bioavailability: 88% (fasting)

            Peak plasma time: 0.5-1.25 hr (fasting); 0.75-2 hr (high fat meal)

            Food delays absorption and a reduction in peak plasma concentration by a mean of 59% and of systemic exposure (AUC) by 37%

            Distribution

            Protein bound: <1%

            Vd: 190-384 mL/kg

            Metabolism

            The major elimination pathway is by producing carbon dioxide and water via the tricarboxylic acid (Krebs) cycle and secondarily by beta-oxidation

            Primary pathway involves a cytosolic NADP+-linked enzyme, GHB dehydrogenase that catalyzes the conversion of sodium oxybate to succinic semialdehyde, which is then biotransformed to succinic acid by the enzyme succinic semialdehyde dehydrogenase

            Succinic acid enters the Krebs cycle where it is metabolized to carbon dioxide and water

            Elimination

            Half-life: 0.5-1 hr

            Clearance is almost entirely by biotransformation to CO2, which is then eliminated by expiration

            Excretion: Mostly lung (expiration of CO2); <5% urine

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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