Asenapine
Asenapine is an atypical antipsychotic medication used to treat adults with bipolar I disorder (for acute manic or mixed episodes) and schizophrenia. It is administered as a sublingual tablet and works by modulating dopamine and serotonin activity in the brain.
Asenapine is an atypical antipsychotic used to treat bipolar I disorder and schizophrenia by affecting dopamine and serotonin activity.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- N05AH05
- RxNorm
- 784649
- Generic
- Asenapine
- Class
- atc-n05
- Brands
- Secuado, Saphris
- Availability
- rx
- Lactation
- unknown
- Routes
- sublingual
- Forms
- tablet
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 5mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 5mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 5mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
general pregnancyavoid if possible
avoid use during pregnancy unless benefits outweigh risks to fetus
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use near delivery due to risk of neonatal extrapyramidal symptoms
monitor newborn for withdrawal symptoms and EPS
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
asenapine is excreted in breast milk - do not breastfeed during treatment
monitor infant for sedation, feeding problems, and developmental delays
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly with dementiaavoid use
contraindicated in elderly with dementia-related psychosis due to increased mortality risk
monitor for cerebrovascular events and mortality
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
general geriatricstart at lower dose
use lower starting dose and slower titration due to increased sensitivity
monitor blood pressure, orthostatic hypotension, and sedation
Use with caution and monitor for adverse effects.
pediatric_age
adolescents 12 17approved for use
approved for schizophrenia in ages 12-17 and bipolar I disorder in ages 10-17
monitor weight, metabolic parameters, and prolactin levels
Use with caution and monitor for adverse effects.
pediatric_age
children under 10not approved
not approved for children under 10 years of age
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
severe renal impairmentno dose adjustment needed
no significant adjustment needed but use with caution
monitor for adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate hepatic impairmentconsider dose reduction
use lower dose due to reduced metabolism
monitor liver function and drug levels
Use with caution and monitor for adverse effects.
hepatic_impairment
severe hepatic impairmentuse lowest effective dose
use with extreme caution in severe hepatic impairment
close monitoring of liver function and adverse effects
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval for Asenapine (Saphris)
Drug class
Pharmacological classification
Common uses
Therapeutic indications
Primary formulations
Available dosage forms
Asenapine is FDA-approved for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and for treatment of schizophrenia in adults.
Asenapine is an atypical antipsychotic with antagonist activity at dopamine D2 and serotonin 5-HT2A receptors. The exact mechanism of action in bipolar I disorder is not fully understood.
Asenapine is taken sublingually and should not be crushed or swallowed. Common side effects include somnolence, dizziness, and weight gain. Metabolic monitoring is recommended due to potential effects on blood glucose and lipids. It may cause orthostatic hypotension, especially during initial dose titration.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy