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Zuranolone: Difference between revisions

From Pharmacopedia
[unchecked revision][unchecked revision]
Create Zuranolone page (Stahl-sourced detail with skepticism)
 
Sweep: "indications" -> "problems" sitewide terminology update (preserves MedTemplate param name)
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| pregnancy      = Limited data; avoid in pregnancy. Lactation: present in milk; consider risks
| pregnancy      = Limited data; avoid in pregnancy. Lactation: present in milk; consider risks
| legal          = Rx, Schedule IV (US)
| legal          = Rx, Schedule IV (US)
| intro          = '''Zuranolone''' (brand name Zurzuvae) is the first '''oral''' neuroactive steroid approved for postpartum depression, FDA-approved in August 2023. Like brexanolone, it acts as a positive allosteric modulator at GABA-A receptors, including extrasynaptic δ-containing subtypes thought to mediate antidepressant effect. Administered as a 14-day fixed-duration course rather than chronic daily dosing — an unusual paradigm in psychiatry. Initially studied for major depressive disorder (MDD) as well but the MDD application was rejected by FDA; only PPD indication approved.
| intro          = '''Zuranolone''' (brand name Zurzuvae) is the first '''oral''' neuroactive steroid approved for postpartum depression, FDA-approved in August 2023. Like brexanolone, it acts as a positive allosteric modulator at GABA-A receptors, including extrasynaptic δ-containing subtypes thought to mediate antidepressant effect. Administered as a 14-day fixed-duration course rather than chronic daily dosing — an unusual paradigm in psychiatry. Initially studied for major depressive disorder (MDD) as well but the MDD application was rejected by FDA; only PPD problem approved.
| pharmacodynamics= Positive allosteric modulator at synaptic and extrasynaptic GABA-A receptors at the neuroactive steroid binding site, with affinity for δ-containing extrasynaptic receptors. Oral bioavailability with food enables outpatient dosing, unlike brexanolone's IV infusion.
| pharmacodynamics= Positive allosteric modulator at synaptic and extrasynaptic GABA-A receptors at the neuroactive steroid binding site, with affinity for δ-containing extrasynaptic receptors. Oral bioavailability with food enables outpatient dosing, unlike brexanolone's IV infusion.
| effects        = Somnolence (most common, can affect driving — black-box warning about CNS depressant activities for ≥12 hours after dose), dizziness, sedation, headache, diarrhea, fatigue. Suicidal thoughts reported.
| effects        = Somnolence (most common, can affect driving — black-box warning about CNS depressant activities for ≥12 hours after dose), dizziness, sedation, headache, diarrhea, fatigue. Suicidal thoughts reported.