milsaperidoneAntipsychoticBrands: BysantiLabel unavailableUnavailable | Schizophrenia (adults)
Acute manic/mixed episodes in bipolar I disorder (adults) Label unavailableUnavailable | Schizophrenia: titrate over 7 days from 1 mg BID to 6-12 mg BID (12-24 mg/day). Bipolar I mania: titrate over 5 days to 12 mg BID (24 mg/day). | Dopamine D2 and serotonin 5-HT2A antagonist with adrenergic α1 blockade; active metabolite of iloperidone requiring structured titration. | CYP2D6, CYP3A4 | Single-dose mean 26 h; Steady-state mean 33 h | No | | - Metabolic: weight/BMI, fasting glucose/HbA1c, and lipids (baseline and periodic).
- QTc: consider ECG monitoring when risk factors or QT-prolongers are present.
- Sedation: assess next-day impairment and fall risk, especially with other sedatives.
| No | 2026-03-10 |
|---|
| Schizophrenia (adults) View labelExact | Titrate: Day 1 1 mg BID → Day 2 2 mg BID → Day 3 4 mg BID → Day 4 6 mg BID → Day 5 8 mg BID; maintenance target 6–12 mg BID (12–24 mg/day). | Dopamine D2/D3 and serotonin 5-HT2A antagonist with high affinity for adrenergic α1 receptors, requiring slow titration. | CYP2D6, CYP3A4 | Single-dose mean 18 h; Steady-state mean 23 h | No | | - Metabolic: weight/BMI, fasting glucose/HbA1c, and lipids (baseline and periodic).
- QTc: consider ECG monitoring when risk factors or QT-prolongers are present.
- Sedation: assess next-day impairment and fall risk, especially with other sedatives.
| No | 2025-09-26 |
|---|
| Schizophrenia; acute mania or mixed episodes (bipolar I) as monotherapy or adjunct; irritability associated with autistic disorder. View labelExact | Schizophrenia (adults): start 1–2 mg/day; increase by 1–2 mg/day to 4–6 mg/day (doses >6 mg/day increase EPS). | Dopamine D2 and serotonin 5‑HT2A receptor antagonism; also alpha‑1 and H1 activity. | CYP2D6 | Single-dose mean 3 h; Steady-state mean 21 h | No | - Weight
- Sedation
- EPS
- Prolactin
| - Metabolic: weight/BMI, fasting glucose/HbA1c, and lipids (baseline and periodic).
- EPS: monitor akathisia/parkinsonism; periodic AIMS for tardive dyskinesia.
- Prolactin: monitor for symptoms (amenorrhea, galactorrhea, sexual dysfunction).
- Sedation: assess next-day impairment and fall risk, especially with other sedatives.
| q2wk; Monthly (q4wk); q4wk or q8wk (by dose) | 2025-12-28 |
|---|
| Schizophrenia (adults)
Schizophrenia (adolescents 13–17)
Bipolar I depression (adults)
Bipolar I depression (pediatrics 10–17) View labelExact | Adult schizophrenia: start 40 mg once daily with food; titrate in 40 mg increments to 40–160 mg/day based on response and tolerability. | D2 and 5‑HT2A antagonism; 5‑HT7 antagonism; partial 5‑HT1A agonism. | CYP3A4 | Steady-state mean 18 h | No | | - Metabolic: weight/BMI, fasting glucose/HbA1c, and lipids (baseline and periodic).
- EPS: monitor akathisia/parkinsonism; periodic AIMS for tardive dyskinesia.
| No | 2026-02-12 |
|---|