{
 "query": "zuranolone",
 "ingredient": "zuranolone",
 "slug": "zuranolone",
 "rxcui": "2669905",
 "brands": [
  "Zurzuvae"
 ],
 "names": [
  "zuranolone"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 1
  },
  "boxed_warning": "WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects [see Warnings and Precautions ( 5.1 , 5.2 )] . Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after ZURZUVAE administration for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence, or the degree of driving impairment caused by ZURZUVAE [see Warnings and Precautions ( 5.1 )] . WARNING: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES See full prescribing information for complete boxed warning. ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects. Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after administration. Patients may not be able to assess their own driving competence or the degree of impairment caused by ZURZUVAE ( 5.1 , 5.2 ) .",
  "indications_and_usage": "is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults. ( 1 )",
  "contraindications": "None. None. ( 4 )",
  "warnings_and_cautions": "Depressant Effects: ZURZUVAE can cause CNS depressant effects such as somnolence and confusion. If patients develop CNS depression, consider dosage reduction or discontinuation of ZURZUVAE. ( 5.2 ) Suicidal Thoughts and Behavior: Consider changing the therapeutic regimen, including discontinuing ZURZUVAE, in patients whose PPD worsens, or who experience emergent suicidal thoughts and behaviors. ( 5.3 ) Embryo-fetal Toxicity: May cause fetal harm. Advise a pregnant woman of the potential risk to an infant exposed to ZURZUVAE in utero. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during ZURZUVAE treatment and for one week after the final dose. ( 5.4 , 8.1 , 8.2 , 8.3 ) 5.1 Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects [see Warnings and Precautions ( 5.2 )] . In two driving simulation studies, the driving ability of healthy adults was impaired in a dose-dependent manner following repeat nighttime administration of 30 mg of ZURZUVAE (0.6 times the recommended dose) for 5 days as well as 50 mg of ZURZUVA...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling: Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities [see Warnings and Precautions ( 5.1 )] Central Nervous System Depressant Effects [see Warnings and Precautions ( 5.2 )] Suicidal Thoughts and Behavior [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence \u22655% and greater than placebo) were somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-844-987-9882 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ZURZUVAE for the treatment of postpartum depression (PPD) was evaluated in two placebo-controlled clinical studies in 347 women with PPD treated with 50 mg of ZURZUVAE (Study 1), or with another zuranolone capsule formulation approxi...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance ZURZUVAE contains zuranolone, a Schedule IV controlled substance. 9.2 Abuse Zuranolone has abuse potential with associated risks of misuse, abuse, and substance use disorder including addiction. Abuse is the intentional non-therapeutic use of a drug, even once, for its desired psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Individuals with a history of drug abuse or substance use disorders may be at a greater risk of these outcomes with ZURZUVAE. In a human abuse potential study, single oral doses of 30 mg, 60 mg, and 90 mg of ZURZUVAE (0.6 times, 1.2 times, and 1.8 times the recommended daily dose, respectively) were compared to single oral doses...",
  "controlled_substance": "9.1 Controlled Substance ZURZUVAE contains zuranolone, a Schedule IV controlled substance.",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities Inform patients that ZURZUVAE causes driving impairment. Advise patients to take ZURZUVAE in the evening. Advise patients not to drive a motor vehicle or engage in other potentially hazardous activities requiring complete mental alertness, such as operating machinery, until at least 12 hours after ZURZUVAE administration. Warn patients that they may not be able to assess their own ability to drive or the degree of impairment caused by ZURZUVAE [see Warnings and Precautions ( 5.1 )] . Central Nervous System Depressant Effects Inform patients that ZURZUVAE can cause somnolence, dizziness, sedation, and confusion. Advise patients to use caution if taking ZURZUVAE in combination with alcohol, other CNS depressants, or medications that increase the concentration of ZURZUVAE [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.1 ) and Drug Interactions ( 7 )] . Suicidal Thoughts and Behavior Advise patients to look for the emergence of suicidal thoughts and behaviors and instruct them to report such symptoms to the health...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 04/2026 MEDICATION GUIDE ZURZUVAE \u00ae (zur-ZOO-vay) (zuranolone) capsules, for oral use, CIV What is the most important information I should know about ZURZUVAE? ZURZUVAE can cause serious side effects, including: Decreased ability to drive or do other dangerous activities. ZURZUVAE can decrease your awareness and alertness, which can affect your ability to drive safely or safely do other dangerous activities. Do not drive , operate machinery, or do other dangerous activities until at least 12 hours after taking each dose during your 14-day treatment course of ZURZUVAE. You may not be able to tell on your own if you can drive safely or tell how much ZURZUVAE is affecting you. Decreased awareness and alertness [central nervous system (CNS) depressant effects]. ZURZUVAE can cause sleepiness, drowsiness, slow thinking, dizziness, confusion, and trouble walking. Because of these symptoms, you may be at a higher risk for falls during treatment with ZURZUVAE. Taking alcohol, other medicines that cause CNS depressant effects, or opioids while taking ZURZUVAE can make these symptoms worse and may also ...",
  "clinical_studies": "14.1 Postpartum Depression The efficacy of ZURZUVAE for the treatment of postpartum depression (PPD) in adults was demonstrated in two randomized, placebo-controlled, double-blind, multicenter studies (Study 1, NCT04442503 and Study 2, NCT02978326) in women with PPD who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode (DSM-5) with onset of symptoms in the third trimester or within 4 weeks of delivery. In these studies, concomitant use of existing oral antidepressants was allowed for patients taking a stable dose of oral antidepressant for at least 30 days before baseline. These studies included patients with HAMD-17 scores \u226526 at baseline. In Study 1, patients received 50 mg of ZURZUVAE (N=98) or placebo (N=97) once daily in the evening with fat-containing food for 14 days, with the option to reduce the dosage based on tolerability to 40 mg once daily of ZURZUVAE or placebo. The patients were followed for a minimum of 4 weeks after the 14-day treatment course. In Study 2, patients received another zuranolone capsule formulation (approximately equivalent to 40 mg of ZURZUVAE) (N=76) or placebo (N=74) once daily in the evening with...",
  "brand_name": "ZURZUVAE",
  "manufacturer": "Biogen MA Inc.",
  "application_number": "NDA217369",
  "pharm_class_epc": [
   "Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260615",
  "set_id": "f18e53b0-d0bb-422d-8de7-ab64b7292b29",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 1581,
  "serious": 214,
  "death": 7,
  "hospitalization": 71,
  "primary_suspect": 1578,
  "top_reactions": [
   [
    "Somnolence",
    519
   ],
   [
    "Dizziness",
    304
   ],
   [
    "Fatigue",
    241
   ],
   [
    "Anxiety",
    126
   ],
   [
    "Sedation",
    118
   ],
   [
    "Feeling Abnormal",
    108
   ],
   [
    "Suicidal Ideation",
    95
   ],
   [
    "Tremor",
    93
   ],
   [
    "Feeling Drunk",
    77
   ],
   [
    "Depression",
    72
   ],
   [
    "Nausea",
    69
   ],
   [
    "Drug Ineffective",
    65
   ],
   [
    "Memory Impairment",
    63
   ],
   [
    "Gait Disturbance",
    61
   ],
   [
    "Insomnia",
    57
   ]
  ],
  "by_year": {
   "2021": 2,
   "2023": 1,
   "2024": 379,
   "2025": 753,
   "2026": 446
  },
  "by_year_primary": {
   "2021": 2,
   "2023": 1,
   "2024": 378,
   "2025": 752,
   "2026": 445
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 1,
  "nda": 1,
  "anda": 0,
  "first_approval": "20230804",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 2,
  "labeling_recent": 2,
  "sponsors": [
   "BIOGEN"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/04/2023"
 },
 "trials": {
  "total": 17,
  "completed": 13,
  "terminated": 2,
  "with_results": 12,
  "industry": 16,
  "phase3": 8,
  "results_share": 0.9230769230769231,
  "terminated_share": 0.11764705882352941
 },
 "pubmed": {
  "rct": 14,
  "meta": 12,
  "recent_rct": 14,
  "cochrane": [
   {
    "pmid": "40562419",
    "title": "Brexanolone, zuranolone and related neurosteroid GABA(A) receptor positive allosteric modulators for postnatal depression",
    "year": "2025"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 708053.8,
  "records": 14779,
  "by_name": [
   [
    "Zurzuvae",
    708053.8
   ]
  ],
  "names_checked": [
   "zuranolone",
   "Zurzuvae"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 34,
  "beneficiaries": 34,
  "spend": 544445.26,
  "by_brand": [
   {
    "brand": "Zurzuvae",
    "claims": 34,
    "per_claim": 16013.095882,
    "is_generic": false
   }
  ],
  "per_claim": 16013.095882352942
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 60,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death share in reports is near or below the FAERS average (0.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 47,
   "letter": "F",
   "why": [
    "14 randomized trials and 12 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "2 label changes approved since 2021 (-4)",
    "Approved within the last 5 years: long-term safety is not yet known (-10)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $708,054 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 62,
 "grade": "D",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "The most-reported problems in FDA's adverse event data are somnolence, dizziness, fatigue, anxiety. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}