Adult Dosing
Narcolepsy-associated cataplexy/excessive daytime sleepiness
- Start 4.5 g/night PO in two equally divided doses
- Dose should be taken at bedtime while in bed and again 2.5-4 hours later
- Dose may be increased by 1.5 g/night q1-2 wks, if required
- Max: 9 g/night
- Dose range: 6-9 g/night PO divided bid
Notes- Dilute each dose with two ounces (60 mL) of water
- Dose should be given at least 2 hours after meal
- After ingesting each dose, patients should lie down and remain in bed
Pediatric Dosing
Narcolepsy-associated cataplexy/excessive daytime sleepiness
- Safety and effectiveness in patients <16 yrs of age have not been established
- Children >16 yrs
- Start 2.25 g PO bid, may increase by 0.75 g/dose q1-2 wks, if required
- Dose should be taken at bedtime while in bed and again 2.5-4 hours later
- Max: 9 g/night
- Dose range: 6-9 g/night PO divided bid
Notes- Dilute each dose with two ounces (60 mL) of water
- Dose should be given at least 2 hours after meal
- After ingesting each dose, patients should lie down and remain in bed
[Outline]
See Supplemental Patient Information
- Sodium oxybate should only be ingested at bedtime, and while in bed, due to the rapid onset of its CNS depressant effects. Advise patients not to engage in hazardous tasks requiring complete mental alertness or motor coordination for at least 6 hrs after taking the drug
- Do not use sodium oxybate in combination with sedative hypnotics or other CNS depressants. Strongly warn the patients against the use of any alcoholic beverages in conjunction with therapy as the combination of alcohol (ethanol) with sodium oxybate may result in potentiation of the CNS-depressant effects of sodium oxybate and alcohol
- Therapy may impair respiratory drive, especially in patients with already-compromised respiratory function. Life-threatening respiratory depression has been reported if taken more than recommended. High incidence of sleep apnea (even 50%) has been reported in some narcoleptic patients
- Confusion has been reported at all recommended doses from 6-9 g/night. Other neuropsychiatric events such as psychosis, paranoia, hallucinations, and agitation have been associated with this drug. Careful and immediate evaluation is required in patients receiving sodium oxybate
- Depressive symptoms have been reported in majority of patients treated with sodium oxybate. Closely monitor patients with a previous history of a depressive illness and/or suicide attempt for the emergence of depressive symptoms while on sodium oxybate
- Closely monitor elderly patients for impaired motor and/or cognitive function when taking sodium oxybate
- Therapy may cause fecal and/or urinary incontinence. If fecal or urinary incontinence occurs, consider methods to rule out underlying etiologies (e.g., worsening sleep apnea, nocturnal seizures)
- Confused behavior at night and, at times associated with wandering, has been reported that has been associated with significant injury. Evaluate the episodes of sleepwalking and consider appropriate interventions
- Consider daily sodium intake in patients with heart failure, hypertension, or compromised renal function while receiving sodium oxybate
Cautions: Use cautiously in
- Hepatic impairment
- Renal impairment
- Pulmonary impairment
- Cardiac disorder
- Compromised respiratory function
- CHF
- Hypertension
- Hx of drug abuse
- Psychiatric disorder
- Hx of depression
- Seizure disorder
- Sodium restriction
- Hx of incontinence
- Geriatric patients
Supplemental Patient Information
- Advise patients to take the first dose of medicine severe hours after a meal
- Inform patients that they should be seen by the prescriber frequently during the course of their treatment to review dose titration, symptom response and adverse reactions
- Caution patients against the use of alcohol or other sedative hypnotics with sodium oxybate
- Advise patients not to engage in hazardous activities requiring complete mental alertness or motor coordination for at least 6 hrs after taking the drug
Pregnancy Category:B
Breastfeeding: Safety unknown. Manufacturer advises caution.
