What is the Origin of Addyi Alcohol Interaction?

This safety concern was established during the rigorous clinical development program for flibanserin, where co-administration studies clearly demonstrated a high incidence of severe adverse events. The findings led to the necessary post-approval risk evaluation and mitigation strategy (REMS) to ensure patient awareness and safety compliance.

What is the Mechanism of Addyi Alcohol Interaction?

The interaction is twofold: alcohol acts as a central nervous system depressant, and flibanserin also contributes to sedation and hypotension, leading to a synergistic depressant effect. Critically, alcohol can inhibit the CYP3A4 enzyme in the liver, which is responsible for metabolizing flibanserin, resulting in significantly elevated plasma concentrations of the drug and thus exacerbating the risk of severe orthostatic hypotension and syncope.

Addyi Alcohol Interaction ∞ Area

Addyi Alcohol Interaction

Meaning

The Addyi Alcohol Interaction refers to the clinically significant and potentially dangerous adverse reaction that occurs when the medication flibanserin (marketed as Addyi) is consumed concurrently with ethanol. This combination carries a serious risk of profound central nervous system depression and cardiovascular compromise. Due to this risk, regulatory bodies have mandated a Boxed Warning emphasizing the contraindication of this co-administration.