Risperidone

Neuroleptic, Atypical neuroleptic (second-generation), Benzisoxazole, Mood stabilizer

Risperidone

Risperdal (oral), Risperdal M-Tab (ODT), Risperdal Consta (biweekly IM LAI), Perseris (monthly SC LAI), Uzedy (monthly/bimonthly SC LAI), Rykindo (biweekly IM LAI)

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Summary

Classes

Neuroleptic, Atypical neuroleptic (second-generation), Benzisoxazole, Mood stabilizer

Common uses

Schizophrenia (FDA)▲0▼, Bipolar I mania and mixed episodes (FDA)▲0▼, Autism spectrum disorder-associated irritability (FDA, pediatric ages 5+)▲0▼, Schizoaffective disorder (off-label)▲0▼, Severe agitation in dementia (off-label; with mortality-warning caveats)▲0▼

Pharmacy

Starting dose

Schizophrenia / mania: 1 mg PO BID, titrate to 4-8 mg/day. Pediatric autism irritability: 0.25-0.5 mg/day, weight-titrated. Consta LAI: 25 mg IM every 2 weeks after oral overlap

Preparations

Tablets 0.25, 0.5, 1, 2, 3, 4 mg; M-Tab ODT 0.5, 1, 2, 3, 4 mg; oral solution 1 mg/mL; Consta LAI 12.5, 25, 37.5, 50 mg; Perseris SC LAI 90, 120 mg monthly

US FDA Max

16 mg/day (schizophrenia, adult); 6 mg/day (bipolar maintenance, autism irritability)

Pharmacology

Routes

Oral, intramuscular (LAI), subcutaneous (LAI)

Onset

Neuroleptic effect emerges over days to weeks

Duration

24 hours (oral); 2-4 weeks (LAI formulations)

Half-life

Risperidone 3-20 hours; 9-hydroxy-risperidone (paliperidone) ~20-24 hours is the major active metabolite and is separately marketed as a parent compound (Invega)

Bioavailability

~70% (oral)

Pregnancy

Signal for neonatal extrapyramidal symptoms and withdrawal with third-trimester exposure.^{[citation needed]}

Legal status

Rx-only in US. Carries the atypical-neuroleptic Boxed Warning for increased mortality in elderly patients with dementia-related psychosis

Purported mechanism

D2 dopamine receptor antagonist plus 5-HT2A serotonin receptor antagonist, the classical atypical-neuroleptic signature originally derived from clozapine but with a more dopamine-tilted occupancy profile than olanzapine or quetiapine. The high D2 occupancy at therapeutic doses produces the highest rates of hyperprolactinemia among second-generation neuroleptics (galactorrhea, amenorrhea, sexual dysfunction, and bone density loss with chronic use), along with dose-dependent extrapyramidal symptoms above ~6 mg/day.▲0▼ CYP2D6 substrate; CYP2D6 poor metabolizers have higher plasma exposure and may benefit from lower initial dosing. CPIC PGx guidance applies.