LUMRYZ Dosage & Rx Info | Uses, Side Effects

Lumryz Generic Name & Formulations

Legal Class

CIII

General Description

Sodium oxybate 4.5g, 6g, 7.5g, 9g; pkts for ext-rel oral susp.

Pharmacological Class

Antinarcoleptic (CNS depressant).

How Supplied

Pkts—7, 30

Manufacturer

Avadel Pharmaceuticals

Generic Availability

Mechanism of Action

Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that its therapeutic effects on cataplexy and excessive daytime sleepiness are mediated through GABA_B actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.

Lumryz Indications

Indications

Cataplexy or excessive daytime sleepiness in adults with narcolepsy.

Lumryz Dosage and Administration

Adult

Take ≥2hrs after eating. Mix each dose with ~80mL of water. Initially 4.5g/night as a single dose. May increase by 1.5g/night at weekly intervals; usual range: 6–9g/night; max 9g/night. Switch from immediate-release sodium oxybate: use nearest equivalent dose in g/night. Allow 6hrs before becoming active after last dose.

Children

Not established.

Lumryz Contraindications

Contraindications

Concomitant sedative hypnotics or alcohol. Succinic semialdehyde dehydrogenase deficiency.

Lumryz Boxed Warnings

Boxed Warning

CNS depression. Abuse and misuse.

Lumryz Warnings/Precautions

Warnings/Precautions

Risk of CNS depression. Abuse potential (monitor). Respiratory dysfunction. Sleep-related breathing disorders (esp. in men, postmenopausal women not on HRT, obese, or narcolepsy patients). History of depression or suicidal ideation (monitor). Monitor for new or increased behavioral or psychiatric events. Consider sodium intake with heart failure, hypertension, renal insufficiency (see full labeling). Parasomnias. Hepatic impairment: not recommended. Drug abusers. Elderly. Labor & delivery. Pregnancy. Nursing mothers.

REMS

Only available through the Lumryz REMS Program. For more information call (877) 453-1029.

Lumryz Pharmacokinetics

Absorption

Peak plasma concentrations after one 6g dose: 66 mcg/mL.
Time to peak plasma concentration after one 6g dose: 1.5 hours.

Distribution

Apparent volume of distribution: 190–384 mL/kg.

Elimination

Renal (<5%). Half-life: 0.5–1 hour.

Lumryz Interactions

Interactions

See Contraindications. CNS depression potentiated by concomitant other CNS depressants (eg, opioids, benzodiazepines, sedating antidepressants, antipsychotics, general anesthetics, muscle relaxants, sedating antiepileptics, illicit CNS depresants). May be potentiated by divalproex sodium.

Lumryz Adverse Reactions

Adverse Reactions

Nausea, dizziness, enuresis, headache, vomiting; CNS and respiratory depression, sleep-disordered breathing, sleepwalking, depressive symptoms, confusion, anxiety, other behavioral/psychiatric reactions.

Lumryz Clinical Trials

See Literature

Lumryz Note

Notes