Drug Interaction Report

MONITOR: Coadministration with alcohol or other central nervous system (CNS) depressants may enhance the sedative effects of lasmiditan and increase the likelihood and/or severity of cognitive and/or neuropsychiatric adverse reactions. Patients treated with lasmiditan are at risk of CNS depression, including dizziness and sedation, as well as driving impairment. In clinical studies, dizziness and sedation were reported in up to 17% and 7%, respectively, of patients receiving lasmiditan, and dizziness was the most common adverse event resulting in discontinuation (greater than 2%). In a computer-based driving study, a significant, dose-dependent impairment of subjects' ability to drive was observed with single 50, 100, and 200 mg lasmiditan doses at 90 minutes after administration. Concomitant use of lasmiditan and CNS depressants has not been studied clinically.

MANAGEMENT: Caution is advised during coadministration of lasmiditan with alcohol, other CNS depressants, or other agents that cause sedation. Patients should be advised against driving and other activities that require complete mental alertness for at least 8 hours after lasmiditan is administered.

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of ganaxolone. When administered with a high-fat meal, ganaxolone peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 3- and 2-fold, respectively, compared to administration under fasted conditions. Ganaxolone was administered with food in the premarketing study population. The efficacy of ganaxolone when administered in the fasted state is unknown.

GENERALLY AVOID: Concomitant use of ganaxolone with central nervous system (CNS) depressants, including alcohol, may potentiate adverse effects such as somnolence and sedation.

MANAGEMENT: Ganaxolone must be administered with food according to the manufacturer. Patients should be advised to avoid or limit consumption of alcohol and to avoid activities requiring mental alertness such as driving or operating hazardous machinery until they know how the medication affects them.