Zulresso

Zulresso is the brand name for brexanolone, a neuroactive steroid approved for the treatment of postpartum depression (PPD) in adult women. It was developed by Sage Therapeutics and is delivered as a continuous intravenous infusion. Zulresso is notable for being the first medication specifically indicated for PPD.

Brexanolone is a formulation of allopregnanolone, an endogenous neurosteroid. It acts as a positive allosteric modulator of GABA-A receptors, increasing inhibitory neurotransmission in the brain. This mechanism is associated with rapid antidepressant effects in PPD.

Indication and administration: Zulresso is indicated for moderate to severe postpartum depression in adults within four weeks after childbirth. The drug is administered as a continuous IV infusion over about 60 hours in a certified healthcare facility, with ongoing monitoring due to the risk of excessive sedation and loss of consciousness. Patients are observed during the infusion and for a period after completion.

Efficacy and safety: In clinical trials, brexanolone produced a statistically significant improvement in depressive symptoms versus placebo, with onset during the infusion period. Common adverse effects include somnolence, dizziness, dry mouth, and flushing. Serious safety concerns include the potential for deep sedation or loss of consciousness, particularly with concurrent CNS depressants. Safety monitoring and avoidance or cautious use with other sedatives are emphasized in treatment settings.

Regulatory status: FDA approved Zulresso in 2019 for the treatment of postpartum depression. Its use requires administration in a healthcare setting under professional supervision, reflecting its specialized safety precautions.