|SODIUM OXYBATE (GHB)
Classifications: central nervous system (cns) depressant; Therapeutic: cns depressant
Pregnancy Category: B
Controlled Substance: Schedule III
500 mg/mL solution
CNS depressant; the precise mechanism by which sodium oxybate produces anticataplexy in narcolepsy is unknown. Sodium oxybate
is GHB, a known drug of abuse.
Produces anticataplectic effects in narcolepsy and decreases the number of cataplexy events in individuals with narcolepsy.
Also has sedative and amnestic properties.
Treatment of cataplexy in patients with narcolepsy.
Alcohol or sedative-hypnotics or other CNS depressants; patients being treated with sedative-hypnotic agents; psychosis;
coma; eclampsia; patients with succinic semialdehyde dehydrogenase deficiency; compromised respiratory drive, severe depression,
or suicidal tendencies; lactation; children <16 y.
Hepatic dysfunction; compromised respiratory function; sleep disorders; history of seizures; heart failure, hypertension,
impaired renal function; previous history of depressive illness or suicide attempt; elderly; sleep-walking; pregnancy (category
Route & Dosage
Adult: PO Start with 2.25 g given at bedtime while in bed and repeated 2.54 h later. Dose may be increased by 1.5 g/d every
2 wk to a max of 9 g/d in 2 divided doses.
Reduce dose by 50% in patients with hepatic impairment.
- Give at bedtime at least 23 h after the evening meal.
- Dilute each dose with 2 oz (60 mL) of water in the dosing cups provided.
- Instruct patient to remain in bed after taking sodium oxybate.
- Discard any diluted dose that has not been used within 24 h.
- Store at 15°30° C (59°86° F).
Adverse Effects (≥1%)Body as a Whole: Pain, infection,
flu-like syndrome, asthenia, allergic reactions, chills. CNS:
, sleepwalking, headache, dizziness, somnolence,
nervousness, abnormal dreams, insomnia
, agitation, ataxia, convulsion, stupor, tremor. CV:
Hypertension. GI: Nausea,
diarrhea, vomiting, dyspepsia, abdominal pain, anorexia, constipation
Increased alkaline phosphatase, edema, hypercholesteremia, hypocalcemia, weight gain. Respiratory: Pharyngitis,
rhinitis, sinusitis Skin:
Increased sweating, acne
, alopecia, rash. Special Senses:
Amblyopia, tinnitus. Urogenital:
Urinary incontinence, dysmenorrhea, albuminuria, cystitis
, hematuria, metrorrhagia, urinary frequency.
InteractionsDrug: Alcohol, sedative-hypnotics
, other cns depressants
may increase CNS
depressant effects. Food:
High-fat meal will significantly reduce absorption.
Incompletely absorbed, 25% reaches systemic circulation. Peak:
0.051.25 h. Metabolism:
Oxidized in the Krebs' cycle to carbon dioxide and water. Elimination:
Primarily eliminated as carbon dioxide in respiration. Half-Life:
Assessment & Drug Effects
- Monitor for and report immediately any of the following: seizure, respiratory depression, or decreased level of consciousness.
- Monitor closely patients with hepatic insufficiency for adverse events.
- Monitor for and report excessive weight gain and development of edema.
- Lab tests: Perform baseline LFTs; monitor periodically serum electrolytes and lipid profile.
Patient & Family Education
- Do not take sodium oxybate at any time other than at night, immediately before bedtime.
- Be consistent with timing of the evening meal and take this drug at least 23 h after eating.
- Prepare both doses prior to bedtime. After ingesting each dose remain in bed.
- Do not consume alcohol or use other sedative hypnotic drugs with sodium oxybate.
- Do not drive or engage in potentially hazardous activities until reaction to drug is known.