Sovimant (SODIUM OXYBATE)

brands

Class

• Neuroscience-based Nomenclature: GABA receptor agonist
• CNS depressant; GABA-B receptor partial agonist

Sovimant commonly prescribed for

(Bold for FDA approved)

How Sovimant works

• Gamma-hydroxybutyrate (GHB) is an endogenous putative neurotransmitter synthesized from its parent compound, GABA; sodium oxybate is the sodium salt of GHB and is administered exogenously

• Has agonist actions at GHB receptors and partial agonist actions at GABA-B receptors

• Improves slow-wave sleep at night, presumably leaving patients better rested and more alert during the day

How long until Sovimant works

• Can immediately reduce daytime sleepiness

• Can take several days to optimize dosing and clinical improvement

Notable Side Effects

• Dizziness, sedation

• Nausea, vomiting

• Enuresis

• Tremor

Life Threatening Side Effects

• Respiratory depression, especially when taken in overdose

• Neuropsychiatric events (psychosis, depression, paranoia, agitation)

• Confusion and wandering at night (unclear if this is true somnambulism)

weight gain

unusual

sedation

not usual

What to do about Sovimant side effects

• Wait

• Lower the dose

• If unacceptable side effects persist, discontinue use

• Discontinue concomitant medications that might be contributing to sedation

usual dosage range

• Xyrem and Xywav, adults with narcolepsy: 6–9 g/night in 2 doses, 2.5–4 hours apart

• Xyrem and Xywav, pediatric patients with narcolepsy: based on body weight

• Xywav, adults with idiopathic hypersomnia: up to 9 g/night in 2 doses or up to 6 g/night in 1 dose

Dosage Forms

• Oral solution 500 mg/mL

long term use

• Long-term use has not been studied

• The need for continued treatment should be reevaluated periodically

habit forming

• Medical use of sodium oxybate is classified under Schedule III

• Non-medical use of sodium oxybate is classified under Schedule I

• Some patients may develop dependence and/or tolerance; risk may be greater with higher doses

• History of drug addiction may increase risk of dependence

Renal Impairment

• Dose adjustment is not necessary

• Not excreted renally

• Because sodium oxybate has sodium content, this may need to be considered in patients with renal impairment

Hepatic Impairment

• Reduce dose by one-half and monitor patients closely

Cardiac Impairment

• Not studied

• Because sodium oxybate has sodium content, this may need to be considered in patients with hypertension or heart failure

Elderly

• Safety and efficacy have not been established

• Patients should be monitored closely

Children and Adolescents

• Approved for treatment of cataplexy or excessive daytime sleepiness to pediatric patients 7 years of age and older with narcolepsy

Pregnancy

• Controlled studies have not been conducted in pregnant women

• Animal studies do not show adverse effects

• Placental transfer is rapid; GHB has been detected in newborns at delivery following intravenous administration to mothers

• Use in women of childbearing potential requires weighing potential benefits to the mother against potential risks to the fetus

• Generally, sodium oxybate should be discontinued prior to anticipated pregnancies

Breast Feeding

• Some drug is present in human breast milk

• Recommended either to discontinue drug or formula feed