Atypical antipsychotic – dopamine and serotonin receptor antagonist
Updated · Methodology
First line
First-line in acute mania as monotherapy or with lithium/valproate per CANMAT 2018. Dose 2–6 mg once daily. Long-acting injectable is preferred for maintenance of bipolar disorder.
Sources
ICD-10: F31 · ICD-11: 6A60
First line
First-line for schizophrenia per 2020 and NG178 (2020). Starting dose 2 mg once daily, titrated to 4–6 mg. Long-acting injectable Risperdal Consta 25–50 mg every 2 weeks for patients with adherence issues. The Huhn 2019 network meta-analysis showed one of the highest efficacies among atypical antipsychotics, but a worse side-effect profile than aripiprazole – more prolactinemia, metabolic disturbance, and extrapyramidal effects at high doses.
Sources
ICD-10: F20 · ICD-11: 6A20
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Risperidone is an antipsychotic, not a sleep medication. It is prescribed for schizophrenia, bipolar disorder, and behavioral problems in children with autism spectrum disorder ( 2020 and NG178 guidelines). For common insomnia, risperidone does not work: its effect on sleep is a side effect, not therapeutic. The drug carries serious risks: extrapyramidal symptoms (tremor, muscle stiffness), metabolic syndrome, hyperprolactinemia. In elderly patients with dementia, it increases mortality ( boxed warning). If risperidone was prescribed for insomnia, consider seeking a second opinion.
Sources
ICD-10: G47.0 · ICD-11: 7A00
Not recommended
Risperidone is an antipsychotic, not an anxiolytic. It is prescribed for schizophrenia, bipolar disorder, and behavioral problems in children with autism spectrum disorder ( 2020 and NG178 guidelines). For acute stress, risperidone does not work: no clinical studies of such use exist. The drug has serious side effects: extrapyramidal symptoms (tremor, muscle stiffness), metabolic syndrome, hyperprolactinemia. In elderly patients with dementia, it increases mortality ( boxed warning). If risperidone was prescribed for stress, consider seeking a second opinion.
Sources
ICD-10: F41.9 · ICD-11: 6B0Z
A dopamine D2 and serotonin 5-HT2A receptor antagonist. Suppresses positive schizophrenia symptoms via mesolimbic D2 blockade and negative symptoms via prefrontal 5-HT2A. Compared with typical antipsychotics (haloperidol), less extrapyramidal disorder but more prolactin elevation than other atypicals. Active metabolite 9-hydroxyrisperidone (paliperidone) is itself registered as a separate drug. Half-life 20 hours.
Boxed warning
FDA boxed warning: increased mortality in elderly patients with dementia treated with atypical antipsychotics. Not for dementia-related psychosis.
T3 use carries neonatal extrapyramidal and withdrawal risk. In pregnant psychotic patients, decisions are made with the psychiatrist.
Moderate milk concentrations. Use during lactation under monitoring of infant sedation, weight gain, and extrapyramidal symptoms.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
1 pair found. Sorted from critical to minor.
Mechanism
Paroxetine is a strong CYP2D6 inhibitor. Risperidone rises 4-fold – enhanced hyperprolactinaemia and sedation.
Symptoms
Sedation, extrapyramidal symptoms, hyperprolactinaemia.
Management
Reduce risperidone by 50%. Alternative SSRI – sertraline or escitalopram (no CYP2D6 inhibition).
Sources
Verbatim lines from the interaction sections, in the language of the label
«Pharmacokinetic-related Interactions: The dose of risperidone should be adjusted when used in combination with CYP2D6 enzyme inhibitors (e.g., fluoxetine, and paroxetine) and enzyme inducers (e.g…»FDA, section 7 · Open on DailyMed
«Paliperidona: No se recomienda la administración concomitante de risperidona oral con paliperidona ya que paliperidona es el metabolito activo de risperidona y la combinación de los dos puede suponer…»AEMPS, section 4.5 · Open on CIMA
«Pharmacokinetic-related Interactions: The dose of risperidone should be adjusted when used in combination with CYP2D6 enzyme inhibitors (e.g., fluoxetine, and paroxetine) and enzyme inducers (e.g…»FDA, section 7 · Open on DailyMed
«Fármacos que prolongan el intervalo QT: Como ocurre con otros antipsicóticos, se recomienda precaución cuando se recete risperidona con medicamentos que se sabe que prolongan el intervalo QT, tales…»AEMPS, section 4.5 · Open on CIMA
«Fármacos que prolongan el intervalo QT: Como ocurre con otros antipsicóticos, se recomienda precaución cuando se recete risperidona con medicamentos que se sabe que prolongan el intervalo QT, tales…»AEMPS, section 4.5 · Open on CIMA
«Fármacos que prolongan el intervalo QT: Como ocurre con otros antipsicóticos, se recomienda precaución cuando se recete risperidona con medicamentos que se sabe que prolongan el intervalo QT, tales…»AEMPS, section 4.5 · Open on CIMA
«Fármacos que prolongan el intervalo QT: Como ocurre con otros antipsicóticos, se recomienda precaución cuando se recete risperidona con medicamentos que se sabe que prolongan el intervalo QT, tales…»AEMPS, section 4.5 · Open on CIMA
«Fármacos que prolongan el intervalo QT: Como ocurre con otros antipsicóticos, se recomienda precaución cuando se recete risperidona con medicamentos que se sabe que prolongan el intervalo QT, tales…»AEMPS, section 4.5 · Open on CIMA
«Fármacos de acción central y alcohol: Se debe usar risperidona con precaución en combinación con otras sustancias de acción central incluyendo notablemente el alcohol, opiáceos, antihistamínicos y…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: • Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone. Increase the risperidone dose up to double the patient’s usual dose. Titrate slowly. ( 7.1 )»FDA, section 7 · Open on DailyMed
«Fármacos que prolongan el intervalo QT: Como ocurre con otros antipsicóticos, se recomienda precaución cuando se recete risperidona con medicamentos que se sabe que prolongan el intervalo QT, tales…»AEMPS, section 4.5 · Open on CIMA
«Uso concomitante con furosemida: No se ha encontrado ningún mecanismo fisiopatológico que explique este hallazgo, ni se ha observado una causa uniforme de las muertes. No obstante, hay que tener…»AEMPS, section 4.4 · Open on CIMA
«Uso concomitante con furosemida: No se ha encontrado ningún mecanismo fisiopatológico que explique este hallazgo, ni se ha observado una causa uniforme de las muertes. No obstante, hay que tener…»AEMPS, section 4.4 · Open on CIMA
«Fármacos que prolongan el intervalo QT: Como ocurre con otros antipsicóticos, se recomienda precaución cuando se recete risperidona con medicamentos que se sabe que prolongan el intervalo QT, tales…»AEMPS, section 4.5 · Open on CIMA
«Discinesia tardía/AEMPS, section 4.4 · Open on CIMA
«Pharmacodynamic-related Interactions: Concomitant use with methylphenidate, when there is change in dosage of either medication, may increase the risk of extrapyramidal symptoms (EPS). Monitor for…»FDA, section 7 · Open on DailyMed
«Fármacos de acción central y alcohol: Se debe usar risperidona con precaución en combinación con otras sustancias de acción central incluyendo notablemente el alcohol, opiáceos, antihistamínicos y…»AEMPS, section 4.5 · Open on CIMA
«Fármacos que prolongan el intervalo QT: Como ocurre con otros antipsicóticos, se recomienda precaución cuando se recete risperidona con medicamentos que se sabe que prolongan el intervalo QT, tales…»AEMPS, section 4.5 · Open on CIMA
«Fármacos que prolongan el intervalo QT: Como ocurre con otros antipsicóticos, se recomienda precaución cuando se recete risperidona con medicamentos que se sabe que prolongan el intervalo QT, tales…»AEMPS, section 4.5 · Open on CIMA
«Fármacos que prolongan el intervalo QT: Como ocurre con otros antipsicóticos, se recomienda precaución cuando se recete risperidona con medicamentos que se sabe que prolongan el intervalo QT, tales…»AEMPS, section 4.5 · Open on CIMA
«Bloqueantes de los canales de calcio:»AEMPS, section 4.5 · Open on CIMA
«Antiepilépticos:»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: • CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based…»FDA, section 7 · Open on DailyMed
«Metoprolol: Se recomienda precaución cuando se administra citalopram con medicamentos que son metabolizados por esta enzima, y que tienen un estrecho margen terapéutico, p.ej., flecainida…»AEMPS, section 4.5 · Open on CIMA
«Established and Other Potentially Significant Drug Interactions: Antipsychotics : lurasidone pimozide quetiapine e.g. perphenazine, risperidone, thioridazine lurasidone pimozide …»FDA, section 7 · Open on DailyMed
«Otros medicamentos metabolizados por CYP2D6 : Fluoxetina es un potente inhibidor de la enzima CYP2D6, por lo que los tratamientos concomitantes con medicamentos que sean también metabolizados por…»AEMPS, section 4.5 · Open on CIMA
«Uso c onc omitante de paliperidona y r i sper i dona: No se recomienda el uso de paliperidona con risperidona oral dado que paliperidona es el m eta bol it o activo de risperidona y que la…»AEMPS, section 4.5 · Open on CIMA
«Inhibición del isoenzima CYP2D6: Como con otros antidepresivos, entre los que se encuentran otros inhibidores selectivos de la recaptación de serotonina (ISRS), paroxetina inhibe el isoenzima CYP2D6…»AEMPS, section 4.5 · Open on CIMA
«Posibilidad de que afecte a la exposición de otros medicamentos: Se recomienda precaución cuando se administre conjuntamente con medicamentos activados o metabolizados por el CYP2D6, en especial…»AEMPS, section 4.5 · Open on CIMA
«El tratamiento concomitante con medicamentos con índices terapéuticos estrechos metabolizados predominantemente por la CYP2D6 se debe iniciar en el extremo inferior del intervalo de dosis del…»AEMPS, section 4.5 · Open on CIMA
«Established and Other Potentially Significant Interactions: Other antipsychotics: e.g., perphenazine risperidone thioridazine ↑ antipsychotic A decrease in the dose of antipsychotics that are…»FDA, section 7 · Open on DailyMed
«ANTIPSICÓTICOS/AEMPS, section 4.5 · Open on CIMA
«Se recomienda precaución si se administra duloxetina con medicamentos metabolizados predominantemente por el CYP2D6 (risperidona, antidepresivos tricíclicos (ADTs) como nortriptilina, amitriptilina e…»AEMPS, section 4.5 · Open on CIMA
«Escitalopram es un inhibidor de la enzima CYP2D6. Se recomienda precaución cuando escitalopram se administre conjuntamente con otros medicamentos que son metabolizados principalmente por esta enzima…»AEMPS, section 4.5 · Open on CIMA
«Risperidona: Se debe tener precaución y antes de tomar la decisión de uso se deben considerar los riesgos y beneficios de la combinación con furosemida o tratamiento concomitante con otros diuréticos…»AEMPS, section 4.5 · Open on CIMA
«Sustratos de CYP2D6: antipsicóticos (aripiprazol, haloperidol, risperidona, tioridazina),»AEMPS, section 4.5 · Open on CIMA
«Interacciones que disminuyen los niveles de litio: Antipsicóticos típicos y atípicos : se han reportado casos de reacciones neurotóxicas en pacientes tratados tanto con litio como con un…»AEMPS, section 4.5 · Open on CIMA
«Risperidone: Combined use of methylphenidate with risperidone when there is a change in dosage, whether an increase or decrease, of either or both medications, may increase the risk of extrapyramidal…»FDA, section 7 · Open on DailyMed
«Antipsicóticos/AEMPS, section 4.5 · Open on CIMA
«Established and Other Potentially Significant Drug Interactions: Antipsychotics: perphenazine, risperidone, thioridazine ↑ antipsychotics A dose decrease may be needed for these drugs when…»FDA, section 7 · Open on DailyMed
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Risperidone is evaluated for the following indications with varying evidence strength: Bipolar disorder maintenance (evidence tier A), Schizophrenia (evidence tier A), Insomnia and sleep disorders (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Risperidone (≥ 1 in 100): Drowsiness, Weight gain (moderate), Hyperprolactinemia (galactorrhea, amenorrhea, sexual dysfunction), Extrapyramidal effects at doses over 6 mg, Orthostatic hypotension, Constipation. See the Safety section for uncommon and serious reactions.
T3 use carries neonatal extrapyramidal and withdrawal risk. In pregnant psychotic patients, decisions are made with the psychiatrist.
Moderate milk concentrations. Use during lactation under monitoring of infant sedation, weight gain, and extrapyramidal symptoms.
Risperidone is contraindicated in: Risperidone hypersensitivity; Dementia in older adults (raised stroke and mortality risk); Parkinson's disease, Lewy body dementia (worsening risk); QT prolongation; Pregnancy – with caution. Full list in the Safety section.
FDA boxed warning: increased mortality in elderly patients with dementia treated with atypical antipsychotics. Not for dementia-related psychosis.
Direct links to regulator labels. Open in a new tab.
Selank (Thr-Lys-Pro-Arg-Pro-Gly-Pro), Valeriana officinalis (root extract), Ziprasidone, Zolpidem, Amisulpride, Clobazam, Melissa officinalis (leaf extract), Paliperidone