Asenapine: uses, dosing, side effects & brands
Asenapine is an atypical antipsychotic sold in the U.S. under 3 brand and generic names, for bipolar disorder and schizophrenia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Atypical Antipsychotic
- Treats (across its forms)
- Bipolar Disorder and Schizophrenia
- Available as
- Tablet · Film, extended release
- Sold as
- 3 products — Asenapine Maleate, Saphris and Secuado
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 24 hours (terminal/elimination half-life)
- What the pharmacy pays
- about $74 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
How Asenapine Maleate is dosed
From the FDA label for Asenapine Maleate (application ANDA205960). Other asenapine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Starting Dose Recommended Dose Maximum Dose Schizophrenia – acute treatment in adults ( 2.2 ) 5 mg sublingually twice daily 5 mg sublingually twice daily 10 mg sublingually twice daily Schizophrenia – maintenance treatment in adults ( 2.2 ) 5 mg sublingually twice daily 5-10 mg sublingually twice daily 10 mg sublingually twice daily Bipolar mania-adults: acute and maintenance monotherapy ( 2.3 ) 5-10 mg sublingually twice daily 5-10 mg sublingually twice daily 10 mg sublingually twice daily Bipolar mania – pediatric patients (10 to 17 years): monotherapy ( 2.3 ) 2.5 mg sublingually twice daily 2.5-10 mg sublingually twice daily 10 mg sublingually twice daily Bipolar mania – adults: as an adjunct to lithium or valproate ( 2.3 ) 5 mg sublingually twice daily 5-10 mg sublingually twice daily 10 mg sublingually twice daily Do not swallow tablet. Asenapine sublingual tablets should be placed under the tongue and left to dissolve completely. The tablet will dissolve in saliva within seconds. Eating and drinking should be avoided for 10 minutes after administration. ( 2.1 , 17 ) 2.1 Administration Instructions Asenapine is a sublingual tablet. To ensure optimal absorption, patients should be instructed to place the tablet under the tongue and allow it to dissolve completely. The tablet will dissolve in saliva within seconds. Asenapine sublingual tablets should not be split, crushed,…
Everything below is the FDA label for Asenapine Maleate (tablet). Asenapine is also sold as film, extended release, and those are different medicines to take — follow the label for the one you were prescribed.
Asenapine Maleate side effects
The following adverse reactions are discussed in more detail in other sections of the labeling: Use in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1 and 5.2 )] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.3)] Tardive Dyskinesia [see Warnings and Precautions (5.4 )] Metabolic Changes [see Warnings and Precautions (5.5 )] Hypersensitivity Reactions [see Contraindications , Warnings and Precautions (5.6 )] Orthostatic Hypotension, Syncope, and other Hemodynamic Effects [see Warnings and Precautions (5.7 )] Falls [see Warnings and Precautions (5.8 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.9 )] QT Interval Prolongation [see Warnings and Precautions (5.10 )] Hyperprolactinemia [see Warnings and Precautions (5.11 )] Seizures [see Warnings and Precautions (5.12 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.13 )] Body Temperature Regulation [see Warnings and Precautions (5.14 )] Dysphagia [see Warnings and Precautions (5.15 )] The most common adverse reactions (≥5% and at least twice the rate of placebo) reported with acute treatment in adults with schizophrenia were akathisia, oral hypoesthesia, and somnolence. The safety profile of asenapine sublingual tablets in the maintenance treatment of schizophrenia in adults was similar to that…
Who shouldn’t take Asenapine Maleate
Asenapine sublingual tablets are contraindicated in patients with: Severe hepatic impairment (Child-Pugh C) [see Specific Populations (8.7) , Clinical Pharmacology (12.3 )]. A history of hypersensitivity reactions to asenapine. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash [see Warnings and Precautions (5.6) , Adverse Reactions (6) ]. Severe hepatic impairment (Child-Pugh C). ( 8.7 , 12.3 ) Known hypersensitivity to asenapine sublingual tablets, or to any components in the formulation. ( 4 , 5.6 , 17 )
Asenapine Maleate drug interactions
Antihypertensive Drugs: Asenapine sublingual tablets may cause hypotension. ( 5.7 , 7.1 , 12.3 ) Paroxetine (CYP2D6 substrate and inhibitor): Reduce paroxetine by half when used in combination with asenapine sublingual tablets. ( 7.1 , 12.3 ) 7.1 Drugs Having Clinically Important Drug Interactions with Asenapine Sublingual Tablets Table 12: Clinically Important Drug Interactions with Asenapine Sublingual Tablets Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Antihypertensive Drugs Because of its α 1 -adrenergic antagonism with potential for inducing hypotension, asenapine sublingual tablets may enhance the effects of certain antihypertensive agents [see Warnings and Precautions (5.7) ]. Monitor blood pressure and adjust dosage of antihypertensive drug accordingly. Strong CYP1A2 Inhibitors (e.g., Fluvoxamine) Asenapine sublingual tablets are metabolized by CYP1A2. Marginal increase of asenapine exposure was observed when asenapine sublingual tablets are used with fluvoxamine at 25 mg administered twice daily [see Clinical Pharmacology (12.3) ] . However, the tested fluvoxamine dose was suboptimal. Full therapeutic dose of fluvoxamine is expected to cause a greater increase in asenapine exposure. Dosage reduction for asenapine sublingual tablets based on clinical response may be necessary. CYP2D6 substrates and inhibitors (e.g., paroxetine) Asenapine sublingual tablets may enhance the inhibitory effects of paroxetine on its own metabolism. Concomitant use of paroxetine with asenapine sublingual tablets increased the paroxetine exposure by 2-fold as compared to use paroxetine alone [see Clinical Pharmacology (12.3) ]. Reduce paroxetine dose by half when paroxetine is used in combination with asenapine sublingual tablets. 7.2 Drugs Having No Clinically Important Interactions with Asenapine Sublingual Tablets No dosage adjustment of asenapine sublingual tablets are necessary when administered concomitantly with paroxetine (see Table 12 in Drug Interactions (7.1) for paroxetine dosage adjustment), imipramine, cimetidine, valproate, lithium, or a CYP3A4 inducer (e.g., carbamazepine, phenytoin, rifampin). In addition, valproic acid and lithium pre-dose serum concentrations collected from an adjunctive therapy study were comparable between asenapine-treated patients and placebo-treated patients indicating a lack of effect of asenapine on valproic and lithium plasma levels.
Every asenapine product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $74 | View → | |
| 2 | 70/100 | Prescription | Tablet | Generic | $74 | View → | |
| 3 | Not yet rated | Prescription | Film | Generic | $74 | View → |
What asenapine pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 10 | 10 mg | white | round | — |
| B;1 | 5 mg | white | round | — |
| B;2 | 10 mg | white | round | — |
| B;3 | 5 mg | white | round | — |
| B;4 | 10 mg | white | round | — |
| B;5 | 2.5 mg | white | round | — |
| B;4 | 10 mg | white | round | — |
| 5 | 5 mg | white | round | — |
| B;3 | 5 mg | white | round | — |
| B;5 | 2.5 mg | white | round | — |
| B;1 | 5 mg | white | round | — |
| B;2 | 10 mg | white | round | — |
Can you crush or split asenapine?
At least one asenapineproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each asenapine label says about crushing, splitting and chewingHow long asenapine keeps
No asenapine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does asenapine expire? The in-use limits and storage rules from its labelsAsenapine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for asenapine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the use of asenapine during breastfeeding. If asenapine is required by the mother, it is not a reason to discontinue breastfeeding. However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised March 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about asenapine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,043 reports naming asenapine, and the FDA flagged 81% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- weight increased135 reports
- akathisia125 reports
- schizophrenia106 reports
- sedation91 reports
- therapeutic product effect incomplete90 reports
- depression86 reports
- leukopenia82 reports
- hallucination, auditory80 reports
Read these as a signal, not a rate. A report does not mean asenapine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
How long asenapine stays in your system
The elimination half-life of asenapine is about 24 hours (terminal/elimination half-life). This is the terminal (elimination) half-life, reported "following an initial more rapid distribution phase" — so it is the beta/terminal value, not the faster distribution phase. No active metabolite outlasts the parent: the label states "asenapine activity is primarily due to the parent drug," and the main circulating metabolites (predominantly asenapine N+-glucuronide, plus N-desmethylasenapine) are not active drivers of effect. Population effects the label names: exposure in elderly patients is 30–40% higher (though no dosage adjustment is recommended on age alone); severe hepatic impairment (Child-Pugh C) raises asenapine exposure ~7-fold and the drug is contraindicated there, while mild-to-moderate hepatic impairment (Child-Pugh A/B) needs no adjustment; renal impairment had no clinically meaningful effect on exposure and needs no dosage adjustment (effect of dialysis not studied). This is a sublingual product — swallowing it drops bioavailability below 2%.
Asenapine sublingual tablets — DailyMed label, §12.3 Pharmacokinetics ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is Asenapine Maleate?
Asenapine sublingual tablets contain asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is(3a RS ,12b RS )-5-Chloro-2-methyl-2,3,3a,12b-tetrahydro-1 H dibenzo[2,3:6,7]oxepino[4,5- c ]pyrrole(2 Z )-2-butenedioate (1:1).
What kind of drug is asenapine?
The FDA classifies asenapine as an atypical antipsychotic. Atypical antipsychotics block dopamine D2 receptors and serotonin 5-HT2A receptors in the brain, rebalancing these signaling chemicals to reduce hallucinations, delusions, and mood symptoms in conditions like schizophrenia and bipolar disorder. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does asenapine stay in your system?
The elimination half-life of asenapine is about 24 hours (terminal/elimination half-life) — that is how long the body takes to clear half of a dose. This is the terminal (elimination) half-life, reported "following an initial more rapid distribution phase" — so it is the beta/terminal value, not the faster distribution phase. No active metabolite outlasts the parent: the label states "asenapine activity is primarily due to the parent drug," and the main circulating metabolites (predominantly asenapine N+-glucuronide, plus N-desmethylasenapine) are not active drivers of effect. Population effects the label names: exposure in elderly patients is 30–40% higher (though no dosage adjustment is recommended on age alone); severe hepatic impairment (Child-Pugh C) raises asenapine exposure ~7-fold and the drug is contraindicated there, while mild-to-moderate hepatic impairment (Child-Pugh A/B) needs no adjustment; renal impairment had no clinically meaningful effect on exposure and needs no dosage adjustment (effect of dialysis not studied). This is a sublingual product — swallowing it drops bioavailability below 2%. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take asenapine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run asenapine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is asenapine sold under?
We track 3 asenapine-containing products in the U.S.: Asenapine Maleate, Saphris and Secuado. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does asenapine come in?
Across the brands we track, asenapine is currently marketed as tablet and film, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic asenapine?
Yes. Our catalog lists 1 generic asenapine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Asenapine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/asenapine
- MLA
- “Asenapine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/asenapine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for asenapine on DailyMed (NIH) ↗ — including its boxed warning in full.