VRAYLAR
What it isD3-preferring D2/D3 partial agonist with serotonergic activity; schizophrenia, bipolar disorder, and adjunctive depression.
Why this oneIts unusually broad mood labeling spans bipolar mania, bipolar depression, and adjunctive unipolar depression.
What limits itAkathisia is dose-limiting; long-lived active metabolites delay steady response and make adverse effects linger after stopping.
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Schizophrenia | Adults | 1.5 mg QD | 1.5–6 mg QD | 6 mg/day |
| Schizophrenia | Adolescents 13–17 yr | 0.5 mg QD | 1.5–4.5 mg QD | 4.5 mg/day |
| Bipolar I mania/mixed | Adults | 1.5 mg QD | 3–6 mg QD | 6 mg/day |
| Bipolar I mania/mixed | Children 10–17 yr | 0.5 mg QD | 3 or 4.5 mg QD | 4.5 mg/day |
| Bipolar depression | Adults | 1.5 mg QD | 1.5 or 3 mg QD | 3 mg/day |
| MDD, adjunct to antidepressant | Adults | 1.5 mg QD | 1.5 or 3 mg QD | 3 mg/day |
Titration Bipolar depression & adjunctive MDD: wait ≥14 days before increasing to 3 mg (titration <14 days raises adverse reactions)
Renal CrCl ≥30 mL/min: no adjustment; CrCl <30 mL/min: not evaluated
Hepatic Mild–moderate (Child-Pugh 5–9): no adjustment; severe (10–15): not recommended
Long half-life — dose changes not fully reflected in plasma for several weeks
Pregnancy May cause fetal harm (animal data); pregnancy registry available; third-trimester exposure risks EPS/withdrawal in neonate
Lactation No human data; present in rat milk — weigh benefits vs. risk
⚠ BOXED WARNING
Cost, est. cash$200–$1,200/month
Generic entry2029 est.
Legacy pregnancy categoryUnknown / historical label unavailable
Defining liabilityMetabolic effects, extrapyramidal symptoms/tardive dyskinesia and agent-specific QT or orthostatic risk.

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