Zuranolone - Revision history

MDElliottMD: Em-dash sweep: replace em-dash with comma per project rule; PendellsCorner verbatim quotes preserved.

2026-05-19T03:16:13Z

Em-dash sweep: replace em-dash with comma per project rule; PendellsCorner verbatim quotes preserved.

← Older revision		Revision as of 03:16, 19 May 2026
Line 11:		Line 11:
	\| duration = 14-day course; effect persists after discontinuation in trials		\| duration = 14-day course; effect persists after discontinuation in trials
	\| halflife = ~16-23 hours		\| halflife = ~16-23 hours
	\| bioavailability = Adequate (food-dependent — must take with fatty meal)		\| bioavailability = Adequate (food-dependent, must take with fatty meal)
	\| 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 problem 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.
	\| interactions = <pharmaInteractions/>		\| interactions = <pharmaInteractions/>
	}}		}}

MDElliottMD: Sweep: "indications" -> "problems" sitewide terminology update (preserves MedTemplate param name)

2026-05-19T01:37:45Z

Sweep: "indications" -> "problems" sitewide terminology update (preserves MedTemplate param name)

← Older revision		Revision as of 01:37, 19 May 2026
Line 14:		Line 14:
	\| 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.

Maintenance script: Create Zuranolone page (Stahl-sourced detail with skepticism)

2026-05-16T01:56:00Z

Create Zuranolone page (Stahl-sourced detail with skepticism)

New page

{{MedTemplate
| brand = Zurzuvae
| classes = Neuroactive steroid, GABA-A positive allosteric modulator (oral)
| mechanism = Synthetic neuroactive steroid (an analog of allopregnanolone), bioavailable orally unlike brexanolone. Positive allosteric modulator at GABA-A receptors including extrasynaptic δ-containing subtypes.
| uses = Postpartum depression (PPD) in adults (FDA-approved 2023)
| starting_dose = 50 mg PO once daily with fatty food in the evening × 14 days
| preparations = 20 mg, 25 mg, 30 mg capsules
| fda_max = 50 mg/d × 14 d
| routes = Oral
| onset = Day 3 of dosing in trials; sustained through day 45
| duration = 14-day course; effect persists after discontinuation in trials
| halflife = ~16-23 hours
| bioavailability = Adequate (food-dependent — must take with fatty meal)
| pregnancy = Limited data; avoid in pregnancy. Lactation: present in milk; consider risks
| 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.
| 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.
| interactions = <pharmaInteractions/>
}}

[[Category:Neuroactive Steroids]]
[[Category:GABAA Positive Allosteric Modulators (General)]]
[[Category:GABAergics]]
[[Category:Antidepressants]]