Version July 2025
Sodium oxybate is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in patients treated with sodium oxybate. Many patients who received sodium oxybate during clinical trials in narcolepsy were receiving CNS stimulants.
Sodium oxybate is the sodium salt of gamma hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.
Because of the risks of CNS depression, abuse, and misuse, sodium oxybate is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Lumryz REMS or Xywav and Xyrem REMS.
Dosage guidance:
Safety: Dosing is presented as weight-directed (mg/kg) and fixed doses in grams (g); use caution.
Dosage form information: Immediate-release formulation is available as an oral solution and may be used for initiation and maintenance therapy in all weights. Extended-release formulation is available in fixed dose packets for oral suspension that require mixing at the time of administration; due to available packet strengths, extended-release formulation is not appropriate for therapy initiation in patients weighing <45 kg.
Narcolepsy (excessive daytime sleepiness/cataplexy):
Children ≥7 years and Adolescents:
Immediate-release oral solution (Xyrem):
Note: Two doses are administered each night; some patients may require unequal doses to achieve optimal response.
<20 kg: Limited data available: Oral: Initial: 60 to 90 mg/kg/night (total dose) in 2 divided doses; the first dose administered at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer the second dose; titrate every 1 to 2 weeks until efficacy or development of intolerable side effects. Reported maximum daily dose: 180 mg/kg/night (Ref).
20 to <30 kg: Oral: Initial: ≤1 g at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer second dose of ≤1 g. After 1 week, titrate dose based on efficacy and tolerability at weekly intervals; increase dose in ≤0.5 g/dose (≤1 g/night) increments per week; maximum single dose: 3 g/dose; maximum daily dose: 6 g/night.
30 to <45 kg: Oral: Initial: ≤1.5 g at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer second dose of ≤1.5 g. After 1 week, titrate dose based on efficacy and tolerability at weekly intervals; increase dose in ≤0.5 g/dose (≤1 g/night) increments per week; maximum single dose: 3.75 g/dose; maximum daily dose: 7.5 g/night.
≥45 kg: Oral: Initial: ≤2.25 g at bedtime after the patient is in bed, then 2.5 to 4 hours later, administer second dose of ≤2.25 g. After 1 week, titrate dose based on efficacy and tolerability at weekly intervals; increase dose in ≤0.75 g/dose (1.5 g/night) increments per week; maximum single dose: 4.5 g/dose; maximum daily dose: 9 g/night.
Extended-release oral suspension (Lumryz ):
20 to <45 kg: Oral: Initial: Appropriate strengths of extended-release oral suspension dosage form are not available for therapy initiation in this weight group. Initiate sodium oxybate therapy with the immediate-release formulation (Xyrem); once patient has titrated to a stable, effective dose convert the total nightly dose (g/night) to the nearest equivalent extended-release oral suspension (Lumryz) dose to be administered once at night. Do not exceed the following weight-directed maximum daily doses: 20 to <30 kg: 6 g/night; 30 to <45 kg: 7.5 g/night.
≥45 kg: Oral: Initial: 4.5 g at bedtime as a single dose after the patient is in bed; may titrate dose in 1.5 g increments at weekly intervals based on efficacy and tolerability; maximum daily dose: 9 g/night. In adults, the recommended dosage range is 6 to 9 g/night.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Sodium oxybate has high sodium content; use caution in patients with kidney impairment.
Children ≥7 years and Adolescents:
Immediate-release oral solution (Xyrem): Oral: Initial: Reduce total nightly dose by 50% and administer in 2 divided doses.
Extended-release oral suspension (Lumryz): Oral: Do not use to initiate therapy in patients with any degree of liver impairment because necessary dosage reductions may not be feasible with available product strengths. Patients who have been titrated to a maintenance dose on immediate-release solution may be switched to the extended-release suspension if the appropriate dosage strength is available.
(For additional information see "Sodium oxybate (gamma hydroxybutyrate): Drug information")
Narcolepsy: Oral:
ER suspension (Lumryz): 4.5 g as a single dose at bedtime. May increase nightly dose by 1.5 g at weekly intervals based on efficacy and tolerability; recommended dosage range: 6 to 9 g once daily at night. Maximum dose: 9 g/night.
IR solution (Xyrem): Initial: 2.25 g at bedtime after the patient is in bed, and 2.25 g administered 2.5 to 4 hours later (4.5 g/night). May increase nightly dose by 1.5 g (0.75 g at bedtime and 0.75 g administered 2.5 to 4 hours later) at weekly intervals based on efficacy and tolerability; usual effective dosage range: 6 to 9 g per night. Maximum dose: 9 g/night.
Missed second dose: Skip dose and resume usual dosing schedule the next day. Do not administer 2 doses at the same time.
Switching from IR solution (Xyrem) to ER suspension (Lumryz): Administer the nearest total equivalent dose in grams once per night.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
ER suspension (Lumryz): Do not use as initial therapy in patients with hepatic impairment; patients who have been titrated to a maintenance dose on IR solution may be switched to the ER suspension if the appropriate dosage strength is available.
IR solution (Xyrem): Reduce initial dose(s) by 50%.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults unless otherwise indicated.
>10%:
Endocrine & metabolic: Weight loss (children, adolescents: 13%; adults: 1% to 4%)
Gastrointestinal: Nausea (children, adolescents, adults: 6% to 20%), vomiting (children, adolescents, adults: 2% to 18%)
Genitourinary: Urinary incontinence (children, adolescents: 19%; adults: 2% to 9%)
Nervous system: Confusion (2% to 17%), dizziness (children, adolescents, adults: 4% to 15%), headache (children, adolescents: 17%; adults: 7%)
1% to 10%:
Cardiovascular: Peripheral edema (3%)
Dermatologic: Hyperhidrosis (1% to 3%)
Gastrointestinal: Decreased appetite (children, adolescents: 9%; adults: 3% to 4%), diarrhea (3% to 4%), upper abdominal pain (3%)
Nervous system: Anxiety (2% to 8%), central nervous system depression (2%), depression (children, adolescents, adults: 1% to 7%), disorientation (2% to 3%), disturbance in attention (1% to 4%), drowsiness (2% to 8%), intoxicated feeling (3%), irritability (3%), pain (3%), paresthesia (2% to 3%), somnambulism (children, adolescents, adults: 1% to 6%), tremor (2% to 5%)
Neuromuscular & skeletal: Limb pain (3%)
<1%: Nervous system: Suicidal ideation (children, adolescents, adults), suicidal tendencies
Frequency not defined (all populations):
Hematologic & oncologic: Oxygen desaturation
Nervous system: Delirium, emotional disturbance (including emotional lability, obsessive thoughts, outbursts of anger), obtundation
Respiratory: Respiratory depression
Postmarketing (any population):
Cardiovascular: Hypertension
Endocrine & metabolic: Fluid retention
Genitourinary: Nocturia
Hypersensitivity: Hypersensitivity reaction
Nervous system: Aggressive behavior, agitation, drug abuse, falling, hallucination, hangover effect, memory impairment, panic attack, paranoid ideation, parasomnias (sleep driving, sleep eating) (Wallace 2011), psychosis (including acute psychosis) (Langford 2011)
Neuromuscular & skeletal: Arthralgia
Ophthalmic: Blurred vision
Respiratory: Sleep apnea (Hartley 2011)
Concomitant use with alcohol or sedative-hypnotic agents; succinic semialdehyde dehydrogenase deficiency
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to sodium oxybate or any component of the formulation
Concerns related to adverse effects:
• Behavioral and psychiatric effects: Use has been associated with aggression, agitation, anxiety, confusion, depression, paranoia, psychosis, suicidality, and hallucinations; use caution in patients with history of depression and/or suicide attempt.
• CNS depression: Sodium oxybate may impair physical or mental abilities. Patients must be instructed not to engage in hazardous activities requiring mental alertness or motor coordination for at least 6 hours after taking sodium oxybate.
• Parasomnias: Parasomnias, including sleepwalking, may occur with use. Evaluate episodes of sleepwalking and implement appropriate interventions.
• Respiratory depression: Use with caution in patients with compromised respiratory function.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with heart failure or hypertension; contains significant amounts of sodium.
• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment is recommended.
• Renal impairment: Use with caution in patients with renal impairment due to significant amounts of sodium in the product.
• Sleep-related breathing disorders: Sleep-related breathing disorders (eg, sleep apnea) may occur during therapy; may be more common in patients that are obese, male, postmenopausal (not on hormone-replacement therapy), or narcoleptic. Central sleep apnea and oxygen desaturation has been reported in adult and pediatric patients.
Special populations:
• Older adult: Although limited data exists, headache was observed at a higher incidence in older adults ≥65 years of age compared to younger adults. Older adults may also be at increased risk for other CNS effects; use with caution and monitor cognitive/motor function closely.
Other warnings/precautions:
• Abuse/misuse/diversion: Health care providers should be alert to problems of abuse, misuse, and diversion. Patients should be evaluated for a history of drug abuse and should be monitored for signs of misuse, abuse, and substance use disorder.
• Sodium: Contains high sodium content: Use with caution in patients sensitive to high sodium intake (eg, renal impairment, heart failure, hypertension).
• Tolerance/withdrawal: Tolerance to sodium oxybate, or withdrawal following its discontinuation, has not been clearly defined in controlled clinical trials, but has been reported at larger doses used for illicit purposes.
Sodium content for various doses:
|
Total nightly sodium oxybate dose |
Sodium content |
|---|---|
|
3 g |
550 mg |
|
4.5 g |
820 mg |
|
6 g |
1,100 mg |
|
7.5 g |
1,400 mg |
|
9 g |
1,640 mg |
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Packet, Oral:
Lumryz: 4.5 g (7 ea, 30 ea); 6 g (7 ea, 30 ea); 7.5 g (7 ea, 30 ea); 9 g (7 ea, 30 ea) [contains carrageenan]
Solution, Oral:
Xyrem: 500 mg/mL (180 mL)
Generic: 500 mg/mL (180 mL)
Therapy Pack, Oral:
Lumryz Starter Pack: 4.5 g, 6 g, 7.5 g, and 9 g (7 ea, 30 ea) (28 ea) [contains carrageenan]
May be product dependent
Pack (Lumryz Oral)
4.5 g (per each): $395.99
6 g (per each): $527.99
7.5 g (per each): $659.99
9 g (per each): $791.99
Solution (Sodium Oxybate Oral)
500 mg/mL (per mL): $40.13 - $42.82
Solution (Xyrem Oral)
500 mg/mL (per mL): $46.47
Therapy Pack (Lumryz Starter Pack Oral)
4.5 & 6 & 7.5 g (per each): $527.99
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Oral:
Xyrem: 500 mg/mL (180 mL)
C-I (illicit use); C-III (medical use)
Access to sodium oxybate is restricted under the Lumryz REMS or the Xywav and Xyrem REMS. The programs are intended to ensure health care providers are specially certified and is dispensed only by specially certified pharmacies. Patients must also enroll in the program and have documentation of safe use conditions. Further information regarding the Lumryz REMS program may be obtained at 1-877-453-1029 or http://www.lumryzrems.com or for the Xywav and Xyrem REMS at 1-866-997-3688 or http://www.xywavxyremrems.com.
In Canada, access to sodium oxybate is only available through a controlled distribution program due to risks of CNS depression, abuse, and misuse. Health care professionals who prescribe sodium oxybate should be educated and enrolled in the program. Patients must also enroll in the program and have documentation of safe use conditions; enrollment ensures patients have been educated on sodium oxybate preparation, dosing, and scheduling. Only enrolled pharmacies may dispense sodium oxybate. Further information regarding the program may be obtained by calling 1-866-599-7365 or emailing [email protected].
Oral: Administer on an empty stomach at least 2 hours after eating. Each nightly dose should be administered while patient is sitting up in bed; then patient should lie down and remain in bed; sleep generally occurs within 5 to 15 minutes (possibly abruptly without patient feeling drowsy).
Immediate-release oral solution (Xyrem): Prepare both doses prior to bedtime and store out of reach of children; consider storage in a locked place if needed. Using the provided dosing syringe, withdraw the prescribed dose from the bottle; empty the syringe contents into one of the provided empty pharmacy containers; dilute dose by adding 60 mL (~1/4 cup) of water to the dose in the pharmacy container; place the child-resistant cap on the filled pharmacy container and turn clockwise until it clicks into the locked child-resistant position. Repeat process for second dose. Use within 24 hours of dilution. In the morning, rinse containers with water.
Administration of doses: The first dose is administered at bedtime and the second dose 2.5 to 4 hours later; an alarm clock may need to be set for the second dose. For patients who sleep >8 hours per night, the first dose may be administered at bedtime or after an initial period of sleep.
Missed dose: If the second dose is missed, skip that dose and resume therapy the next night. Do not administer both doses at the same time. Diluted doses that are not used should be properly and promptly disposed of.
Extended-release oral suspension (Lumryz): Fill provided mixing cup to line A with cool/cold water (~80 mL [1/3 cup]), empty single dose packet into water, close mixing cup lid, and shake for at least 60 seconds to suspend drug; solution will appear milky and may have some lumps. Do not use hot water. Administer within 30 minutes of mixing. After dose consumed, fill mixing cup to line B with cool/cold water, replace lid, and shake for 10 seconds to mix any remaining medication; patient should consume immediately. In the morning, rinse mixing cup with water.
Oral: Administer on an empty stomach, ≥2 hours after eating. Administer while patient is in bed; patient should lie down immediately after dose and remain in bed.
ER suspension (Lumryz): Administer at bedtime. Prepare dose prior to bedtime. Prior to ingestion, suspend dose in ~1/3 cup (~80 mL) of water in provided mixing cup; do not use hot water. Administer within 30 minutes of mixing.
IR solution (Xyrem): Administer first dose at bedtime. Administer second nightly dose 2.5 to 4 hours after the first dose; an alarm clock may need to be set for the second dose. Prepare both doses prior to bedtime. Prior to ingestion, dilute each dose with ~1/4 cup (60 mL) water in provided empty pharmacy containers.
ER suspension (Lumryz): Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Diluted suspension should be consumed within 30 minutes.
IR solution (Xyrem): Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86 °F). Store in the original bottle. Dispense in tight containers. Diluted solution should be consumed within 24 hours.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021196s042lbl.pdf#page=26, must be dispensed with this medication.
Treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy (Immediate-release oral solution [Xyrem]: FDA approved in ages ≥7 years and adults; extended-release oral suspension [Lumryz]: FDA approved in ages ≥7 years and adults).
Sodium oxybate may be confused with oxybate salts (calcium, magnesium, potassium, and sodium).
Xyrem may be confused with Xywav.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Alcohol (Ethyl): May increase CNS depressant effects of Oxybate Salt Products. Alcohol (Ethyl) may increase serum concentration of Oxybate Salt Products. Specifically, alcohol may increase concentrations of the sodium oxybate extended release suspension. Risk X: Avoid
Alizapride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Amisulpride (Oral): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Articaine: May increase CNS depressant effects of CNS Depressants. Management: Consider reducing the dose of articaine if possible when used in patients who are also receiving CNS depressants. Monitor for excessive CNS depressant effects with any combined use. Risk D: Consider Therapy Modification
Azelastine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Barbiturates: May increase CNS depressant effects of Oxybate Salt Products. Risk X: Avoid
Benperidol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Benzodiazepines: May increase CNS depressant effects of Oxybate Salt Products. Risk X: Avoid
Blonanserin: CNS Depressants may increase CNS depressant effects of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider Therapy Modification
Brimonidine (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Bromopride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Bromperidol: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Buclizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Buprenorphine: CNS Depressants may increase CNS depressant effects of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider Therapy Modification
BusPIRone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Cannabinoid-Containing Products: CNS Depressants may increase CNS depressant effects of Cannabinoid-Containing Products. Risk C: Monitor
Cetirizine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk D: Consider Therapy Modification
Chlormethiazole: May increase CNS depressant effects of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider Therapy Modification
Chlorphenesin Carbamate: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor
CNS Depressants: May increase CNS depressant effects of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider Therapy Modification
DexmedeTOMIDine: CNS Depressants may increase CNS depressant effects of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider Therapy Modification
Difelikefalin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Dihydralazine: CNS Depressants may increase hypotensive effects of Dihydralazine. Risk C: Monitor
Dimethindene (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Dothiepin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
DroPERidol: May increase CNS depressant effects of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider Therapy Modification
Emedastine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk C: Monitor
Entacapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Flunarizine: CNS Depressants may increase CNS depressant effects of Flunarizine. Risk X: Avoid
HydrOXYzine: May increase CNS depressant effects of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider Therapy Modification
Hypnotics (Nonbenzodiazepine): May increase CNS depressant effects of Oxybate Salt Products. Risk X: Avoid
Ixabepilone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Kava Kava: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Ketotifen (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Kratom: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Levocetirizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Lisuride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Lofexidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Loxapine: CNS Depressants may increase CNS depressant effects of Loxapine. Management: Consider reducing the dose of CNS depressants administered concomitantly with loxapine due to an increased risk of respiratory depression, sedation, hypotension, and syncope. Risk D: Consider Therapy Modification
Magnesium Sulfate: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Mequitazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Metergoline: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Methotrimeprazine: CNS Depressants may increase CNS depressant effects of Methotrimeprazine. Methotrimeprazine may increase CNS depressant effects of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider Therapy Modification
Metoclopramide: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
MetyroSINE: CNS Depressants may increase sedative effects of MetyroSINE. Risk C: Monitor
Minocycline (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Moxonidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Nabilone: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Noscapine: CNS Depressants may increase adverse/toxic effects of Noscapine. Risk X: Avoid
Olopatadine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Opicapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Opioid Agonists: CNS Depressants may increase CNS depressant effects of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification
Opipramol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Orphenadrine: CNS Depressants may increase CNS depressant effects of Orphenadrine. Risk X: Avoid
Oxomemazine: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Oxybate Salt Products: CNS Depressants may increase CNS depressant effects of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider Therapy Modification
OxyCODONE: CNS Depressants may increase CNS depressant effects of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification
Paraldehyde: CNS Depressants may increase CNS depressant effects of Paraldehyde. Risk X: Avoid
Periciazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Pipamperone: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor
Piribedil: CNS Depressants may increase CNS depressant effects of Piribedil. Risk C: Monitor
Pramipexole: CNS Depressants may increase sedative effects of Pramipexole. Risk C: Monitor
Procarbazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Rilmenidine: Oxybate Salt Products may increase CNS depressant effects of Rilmenidine. Risk X: Avoid
Ropeginterferon Alfa-2b: CNS Depressants may increase adverse/toxic effects of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider Therapy Modification
ROPINIRole: CNS Depressants may increase sedative effects of ROPINIRole. Risk C: Monitor
Rotigotine: CNS Depressants may increase sedative effects of Rotigotine. Risk C: Monitor
Thalidomide: CNS Depressants may increase CNS depressant effects of Thalidomide. Risk X: Avoid
Valerian: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Valproic Acid and Derivatives: May increase serum concentration of Sodium Oxybate. Management: Decrease the dose of sodium oxybate immediate release oral solution by at least 20% when initiating therapy with valproate products. No dose adjustment recommended when sodium oxybate extended release suspension is combined with valproate products. Risk D: Consider Therapy Modification
Zuranolone: May increase CNS depressant effects of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider Therapy Modification
Administration immediately after a high-fat meal delays absorption and decreases peak serum gamma-hydroxybutyrate level. Management: Administer on an empty stomach ≥2 hours after eating.
Contains a high sodium content; limit dietary intake of sodium.
The injection formulation, when used as an anesthetic during labor and delivery, was shown to cross the placenta; a slight decrease in Apgar scores due to sleepiness in the neonate was observed.
Signs and symptoms of depression or suicidality; emergence of anxiety, confusion, thought disorders, or behavior abnormalities; drug abuse, misuse, and substance use disorder; parasomnias.
The active moiety of sodium oxybate is gamma-hydroxybutyrate (GHB). The therapeutic effects of GHB, a metabolite of gamma aminobutyric acid (GABA), are hypothesized to be mediated by GABAB receptor activity at noradrenergic, dopaminergic, and thalamocortical neurons.
Note: Pharmacokinetic parameters in pediatric patients 7 to 17 years were reported as being similar to adult patients.
Onset: Rapid (≤5 to 15 minutes).
Absorption: Rapid; high-fat meals delay absorption (average Tmax increased 1 hour [extended release] and 1.25 hours [immediate release]) and reduce the Cmax by a mean 33% (extended release), 59% (immediate release) and AUC by 14% (extended release), 37% (immediate release).
Distribution: 190 to 384 mL/kg.
Protein binding: <1%.
Metabolism: Primarily via the Krebs cycle to form water and carbon dioxide; secondarily via beta oxidation; significant first-pass effect; no active metabolites; metabolic pathways are saturable.
Bioavailability: ~88%.
Half-life elimination: 30 to 60 minutes.
Time to peak: Extended release: 90 minutes; Immediate release: 30 to 75 minutes.
Excretion: Primarily pulmonary (as carbon dioxide); urine (<5% as unchanged drug); feces (negligible).
Altered liver function: In patients with cirrhosis (Child's classification A and C), AUC is doubled, elimination half-life is significantly longer, and oral clearance is reduced.
