Patients should avoid taking the muscle weakness and narcolepsy drug sodium oxybate (Xyrem, Jazz Pharmaceuticals) with alcohol or central nervous system (CNS) depressant drugs, according to the FDA.
This combination puts patients at risk for “markedly” impaired consciousness and respiratory depression, which can lead to loss of consciousness, coma and death, the agency said in a statement.
Sodium oxybate is indicted to treat cataplexy and daytime sleepiness in patients with narcolepsy.
Patients taking the medication should not drink alcohol or take opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, muscle relaxants or insomnia drugs.
The main ingredient in sodium oxybate is gamma-hydroxybuytrate (GHB), which can cause adverse events related to central nervous system damage, including death, if abused, the agency noted. Sodium oxybate also can cause confusion, depression and other neuropsychiatric events even if used as prescribed.
In addition to these contraindications, sodium oxybate contains a boxed warning that stipulates it can only be dispensed to patients enrolled in the Xyrem Success Program, an initiative designed to inform pharmacists and patients about correct drug use, as well as drug risks and benefits.