Drug Interactions between aspirin / carisoprodol / codeine and zuranolone

GENERALLY AVOID: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants (e.g., nonbenzodiazepine sedatives/hypnotics, anxiolytics, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol) may result in profound sedation, respiratory depression, coma, and death. The risk of hypotension may also be increased with some CNS depressants (e.g., alcohol, benzodiazepines, phenothiazines).

MANAGEMENT: The use of opioids in conjunction with benzodiazepines or other CNS depressants should generally be avoided unless alternative treatment options are inadequate. If coadministration is necessary, the dosage and duration of each drug should be limited to the minimum required to achieve desired clinical effect, with cautious titration and dosage adjustments when needed. Patients should be monitored closely for signs and symptoms of respiratory depression and sedation, and advised to avoid driving or operating hazardous machinery until they know how these medications affect them. Cough medications containing opioids (e.g., codeine, hydrocodone) should not be prescribed to patients using benzodiazepines or other CNS depressants including alcohol. For patients who have been receiving extended therapy with both an opioid and a benzodiazepine and require discontinuation of either medication, a gradual tapering of dose is advised, since abrupt withdrawal may lead to withdrawal symptoms. Severe cases of benzodiazepine withdrawal, primarily in patients who have received excessive doses over a prolonged period, may result in numbness and tingling of extremities, hypersensitivity to light and noise, hallucinations, and epileptic seizures.

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GENERALLY AVOID: Coadministration with central nervous system (CNS) depressants (e.g., alcohol, benzodiazepines, opioids) or antidepressants may enhance the sedative effect of zuranolone and increase the likelihood or severity of sedation-related adverse reactions. Zuranolone may cause CNS depressant effects such as somnolence, confusion, dizziness, and gait disturbance. In clinical trials, somnolence, dizziness, or confusion were reported at a higher percentage in patients treated with zuranolone compared to placebo which required a dosage reduction of zuranolone, treatment interruption, or cessation. One clinical study reported somnolence in 36% of patients treated with 50 mg zuranolone compared to 6% of patients treated with placebo.

MANAGEMENT: Concomitant use of zuranolone with CNS depressants should generally be avoided. Caution and close monitoring of CNS depressant effects is recommended if concomitant use of zuranolone with CNS depressants, antidepressants, or other agents that can cause sedation is required. If coadministration with another CNS depressant is considered unavoidable or if the patient experiences CNS depressant adverse effects within the 14 days treatment course, a dose reduction to 40 mg once daily for the remainder of the course is recommended. Patients should also be cautioned against driving, operating machinery, or engaging in potentially hazardous activities requiring mental alertness and motor coordination until at least 12 hours after administration of zuranolone.

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GENERALLY AVOID: Coadministration with central nervous system (CNS) depressants (e.g., alcohol, benzodiazepines, opioids) or antidepressants may enhance the sedative effect of zuranolone and increase the likelihood or severity of sedation-related adverse reactions. Zuranolone may cause CNS depressant effects such as somnolence, confusion, dizziness, and gait disturbance. In clinical trials, somnolence, dizziness, or confusion were reported at a higher percentage in patients treated with zuranolone compared to placebo which required a dosage reduction of zuranolone, treatment interruption, or cessation. One clinical study reported somnolence in 36% of patients treated with 50 mg zuranolone compared to 6% of patients treated with placebo.

MANAGEMENT: Concomitant use of zuranolone with CNS depressants should generally be avoided. Caution and close monitoring of CNS depressant effects is recommended if concomitant use of zuranolone with CNS depressants, antidepressants, or other agents that can cause sedation is required. If coadministration with another CNS depressant is considered unavoidable or if the patient experiences CNS depressant adverse effects within the 14 days treatment course, a dose reduction to 40 mg once daily for the remainder of the course is recommended. Patients should also be cautioned against driving, operating machinery, or engaging in potentially hazardous activities requiring mental alertness and motor coordination until at least 12 hours after administration of zuranolone.

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