Section 10 · Monograph
Sodium oxybate ER
Reviewed Nov 2026FDA label
LumryzGABA-B agonist · ER
- Forms
- ER susp packets: 4.5, 6, 7.5, 9g
- Dose
- Start 4.5g once at bedtime, increase 1.5g weekly to 6-9g
- MOA
- GABA-B / GHB receptor agonism, consolidates sleep
Black Box Warning
- CNS depression: respiratory depression, coma and death can occur; do not use with sedative hypnotics or alcohol
- Abuse and misuse (GHB): available only through a restricted REMS program
Indications
- Cataplexy or excessive daytime sleepiness in patients with narcolepsy (age 7 years and older)FDA-labeled
Mechanism of Action
- Extended-release gamma-hydroxybutyrate (GHB) acting at GABA-B and GHB receptors; consolidates nighttime sleep and reduces cataplexy and daytime sleepiness
Full Dosing
Adult / usual
- Start 4.5g once nightly at bedtime while in bed, at least 2 hours after eating; increase by 1.5g weekly to a usual range of 6-9g; maximum 9g
- Mix packet contents with water as directed; keep patients in bed after dosing
Contraindications
- Concomitant sedative hypnotics or alcohol
- Succinic semialdehyde dehydrogenase deficiency
Drug Interactions
- Alcohol, opioids, benzodiazepines and other CNS depressants: profound sedation and respiratory depression
- Valproate may raise oxybate exposure
Adverse Effects
- Nausea, dizziness, enuresis, headache, vomiting
- Respiratory depression and sleepwalking
- Depression, suicidality and hallucinations
- High sodium load (hypertension, heart failure)
Monitoring Parameters
- Respiratory and CNS depression, sleepwalking
- Mood and psychiatric symptoms
- Blood pressure and sodium intake; misuse
Pregnancy & Lactation
- Limited human data; use only if benefit justifies risk
- Excreted in milk in small amounts