Zuranolone
زورانولون
🧠 Nervous SystemGABA-A receptor modulator (postpartum depression)
Market / country: 🇺🇸 USA
Zurzuvae (US)
🧮 Dose calculator
Postpartum depression · Regimen source: FDA Zurzuvae · 2.1
- • If CNS depressant effects: 40 mg. Severe hepatic impairment (Child-Pugh C) or eGFR <60: 30 mg. Not studied beyond 14 days. FDA Zurzuvae · 2.1FDA Zurzuvae · 2.3FDA Zurzuvae · 2.4
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Warnings
- • Boxed warning: impaired driving — no driving or hazardous activity until at least 12 h after each dose during the 14 days. FDA Zurzuvae · Boxed Warning
Formulations
- 20 mg capsule — capsule 🇺🇸 USA FDA Zurzuvae · 3
- 25 mg capsule — capsule 🇺🇸 USA FDA Zurzuvae · 3
- 30 mg capsule — capsule 🇺🇸 USA FDA Zurzuvae · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Zurzuvae · 8.1
“… ntalhealth.org/research/pregnancyregistry/antidepressants/ Risk Summary Based on findings from animal studies, ZURZUVAE may cause fetal harm.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Zurzuvae · 8.2
“Risk Summary Available data from a clinical lactation study in 14 women indicate that zuranolone is present in low levels in human milk (see Data ).”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Zurzuvae · 8.4
“The safety and effectiveness of ZURZUVAE in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Zurzuvae · 8.5
“PPD is a condition associated with pregnancy; there is no geriatric experience with ZURZUVAE in patients with PPD.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Zurzuvae · 8.3
“Contraception Advise female patients of reproductive potential to use effective contraception during treatment with ZURZUVAE and for 1 week after the final dose.”
🔗 Reference links
- FDA (approval record)NDA217369
- DailyMed (FDA label)FDA Zurzuvae
- MedlinePlus (NIH)Zuranolone
- WHO ATC/DDDN06AX31
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Zurzuvae · 3FDA Zurzuvae · 2.1FDA Zurzuvae · 2.3FDA Zurzuvae · 2.4FDA Zurzuvae · Boxed WarningFDA Zurzuvae · 8.1FDA Zurzuvae · 8.2FDA Zurzuvae · 8.4FDA Zurzuvae · 8.5FDA Zurzuvae · 8.3FDA Zurzuvae · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · search
- Clinical review⚠ Unverified