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Asenapine

Asenapine is an atypical antipsychotic medication used to treat schizophrenia and bipolar I disorder in adults, with some formulations also approved for bipolar I disorder in children and adolescents.

Brand names SaphrisSecuado
Drug class Atypical Antipsychotic
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 6 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Other forms & routes:
Transdermal
Asenapine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Asenapine (Saphris, Secuado) is an atypical antipsychotic for schizophrenia and bipolar I disorder that blocks dopamine and serotonin receptors; on the market since about 2010 and available generically, it is a less commonly prescribed option, given as a tablet dissolved under the tongue or a daily skin patch. It is generally reasonably well tolerated, and sleepiness, a numb or tingly mouth, and restlessness are what people notice most. Its boxed warning is a higher risk of death in older adults with dementia-related psychosis, and any new, repetitive involuntary movements (possible tardive dyskinesia) need prompt reporting. Expect blood sugar, cholesterol and weight checks before and during treatment.

Clinical pearls

  • Let the tablet melt completely under the tongue without chewing or swallowing, then skip food and drink for 10 minutes.
  • Mention paroxetine or fluvoxamine to every prescriber, since asenapine can double paroxetine levels and fluvoxamine raises asenapine levels.
  • Stand up slowly, especially early on or alongside blood pressure medicines, because asenapine can make you dizzy or faint.
  • Apply each Secuado patch to clean, dry skin, rotating between upper arm, upper back, abdomen and hip.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Elderly people with dementia-related psychosis who take antipsychotic drugs, including asenapine, have a significantly higher risk of death compared to those taking a placebo. The deaths were most often related to heart problems or infections like pneumonia. Asenapine sublingual tablets are not approved to treat dementia-related psychosis, and this use should be avoided. If you have a loved one with dementia, discuss safer options with their doctor.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asSublingual tablet, Skin patch, Tablet
Earliest FDA record2009
Companies listing it with the FDA7
FDA label last updatedFeb 25, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Asenapine, written from its FDA label.

What Asenapine is used for

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Asenapine is an atypical antipsychotic with FDA-approved uses across two product types — sublingual tablets and a transdermal patch.

  • Schizophrenia in adults (sublingual tablets: Saphris, asenapine generic; skin patch: Secuado)
  • Bipolar I disorder — acute manic or mixed episodes as monotherapy in adults (sublingual tablets only)
  • Bipolar I disorder — acute manic or mixed episodes as monotherapy in patients ages 10 to 17 (sublingual tablets only)
  • Bipolar I disorder — used alongside lithium or valproate in adults (sublingual tablets only)
  • Bipolar I disorder — maintenance monotherapy in adults (sublingual tablets only)

How Asenapine works

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Asenapine blocks several types of receptors in the brain, particularly dopamine D2 receptors and serotonin 5-HT2A receptors. Too much activity at these receptors is linked to symptoms of psychosis and mania. By blocking them, asenapine helps reduce those symptoms. It also acts on a wide range of other serotonin, dopamine, adrenaline, and histamine receptors, which contributes to both its effects and its side effect profile.

The exact mechanism by which asenapine improves symptoms in schizophrenia and bipolar I disorder is not fully known, but the combination of dopamine and serotonin receptor blockade is thought to be central to how it works.

Asenapine dosage

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Asenapine sublingual tablets are taken twice daily, placed under the tongue to dissolve — never swallowed. Avoid eating or drinking for 10 minutes after each dose to ensure proper absorption. Secuado (the skin patch) is applied once daily, worn for 24 hours, and rotated to a different skin site each time.

  • Sublingual tablets: taken twice daily; dissolves in seconds under the tongue
  • Secuado patch: one patch per day, applied to the upper arm, upper back, abdomen, or hip
  • Do not apply heat over a Secuado patch — it raises drug levels
  • Follow your prescriber's instructions closely; do not adjust your dose on your own

Dosing details from the FDA-approved label

From the Asenapine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Schizophrenia – acute treatment in adults (sublingual tablet)
    • 5 mg sublingually twice daily
    • If tolerated, daily dosage can be increased to 10 mg twice daily after one week
    • Maximum: 10 mg sublingually twice daily
    • Do not swallow tablet; avoid eating and drinking for 10 minutes after administration
  • Schizophrenia – maintenance treatment in adults (sublingual tablet)
    • Starting 5 mg sublingually twice daily
    • Recommended 5-10 mg sublingually twice daily
    • Maximum: 10 mg sublingually twice daily
    • Do not swallow tablet; avoid eating and drinking for 10 minutes after administration
  • Bipolar mania – adults: acute and maintenance monotherapy (sublingual tablet)
    • 5-10 mg sublingually twice daily
    • For maintenance, continue the dose received during stabilization (5 mg to 10 mg twice daily), and 10 mg twice daily can be decreased to 5 mg twice daily
    • Maximum: 10 mg sublingually twice daily
    • Do not swallow tablet; avoid eating and drinking for 10 minutes after administration
  • Bipolar mania – pediatric patients (10 to 17 years): monotherapy (sublingual tablet)
    • Start 2.5 mg sublingually twice daily
    • After 3 days increase to 5 mg twice daily, and from 5 mg to 10 mg twice daily after 3 additional days
    • Recommended 2.5-10 mg twice daily
    • Maximum: 10 mg sublingually twice daily
    • Patients aged 10 to 17 years appear to be more sensitive to dystonia with initial dosing when the recommended escalation schedule is not followed
  • Bipolar mania – adults: as an adjunct to lithium or valproate (sublingual tablet)
    • Start 5 mg sublingually twice daily
    • Depending on response and tolerability, can be increased to 10 mg twice daily
    • Recommended 5-10 mg twice daily
    • Maximum: 10 mg sublingually twice daily
    • Do not swallow tablet; avoid eating and drinking for 10 minutes after administration
  • Schizophrenia (Secuado transdermal system)
    • Apply one transdermal system every 24 hours
    • Start at 3.8 mg/24 hours
    • May increase to 5.7 mg/24 hours or 7.6 mg/24 hours, as needed, after one week
    • Maximum: The safety of doses above 7.6 mg/24 hours has not been evaluated in clinical studies
    • Apply to hip, abdomen, upper arm, or upper back; wear one system at a time for 24 hours only
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 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, chewed, or swallowed [see Clinical Pharmacology (12.3) ] . Patients should be instructed to not eat or drink for 10 minutes after administration [see Clinical Pharmacology (12.3) ] . 2.2 Schizophrenia The recommended dose of asenapine sublingual tablets is 5 mg given twice daily. In short-term controlled trials, there was no suggestion of added benefit with a 10 mg twice daily dose, but there was a clear increase in certain adverse reactions. If tolerated, daily dosage can be increased to 10 mg twice daily after one week. The safety of doses above 10 mg twice daily has not been evaluated in clinical studies [see Clinical Studies (14.1) ]. 2.3 Bipolar I Disorder Acute Treatment of Manic or Mixed Episodes: Monotherapy in Adults : The recommended starting and treatment dose of asenapine sublingual tablets is 5 mg to 10 mg twice daily. The safety of doses above 10 mg twice daily has not been evaluated in clinical trials [see Clinical Studies (14.2) ].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Asenapine side effects

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The most commonly reported side effects from asenapine clinical trials include:

Common side effects

  • Sleepiness or sedation
  • Numbness or tingling in the mouth (oral hypoesthesia)
  • Restlessness or urge to move (akathisia)
  • Dizziness
  • Uncontrolled muscle movements (extrapyramidal symptoms)
  • Nausea
  • Increased appetite or weight gain
  • Dry mouth
  • Numbness or tingling in the mouth (oral hypoesthesia) — especially with sublingual forms
  • Altered taste (dysgeusia) — reported in pediatric patients

When to get medical help

  • Call your doctor right away if you notice uncontrolled, repetitive muscle movements (could be tardive dyskinesia)
  • Seek emergency help for high fever, severe muscle stiffness, confusion, or rapid heart rate (signs of neuroleptic malignant syndrome)
  • Tell your doctor about significant weight gain, increased thirst, or frequent urination (signs of high blood sugar or diabetes)
  • Get help immediately for severe allergic reactions: swollen tongue, trouble breathing, rash, or sudden drop in blood pressure
  • Contact your doctor if you feel faint when standing up (orthostatic hypotension)
  • Report any new or worsening irregular heartbeat (QT prolongation risk)
  • Tell your doctor if you develop signs of low white blood cell count: fever, chills, or frequent infections
  • Seek care immediately for a seizure

More serious reactions — including tardive dyskinesia (potentially permanent involuntary movements), neuroleptic malignant syndrome (high fever, muscle rigidity, confusion), and significant blood sugar or cholesterol changes — require prompt medical attention. Contact your doctor right away if any of these occur.

Asenapine warnings and precautions

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  • Elderly patients with dementia-related psychosis: Asenapine is NOT approved for this use. Antipsychotics significantly increase the risk of death in this population. This is the most critical safety concern.
  • Tardive dyskinesia: Long-term use can cause potentially irreversible, involuntary muscle movements. Risk increases with dose and duration. Use the lowest effective dose for the shortest time needed.
  • Neuroleptic malignant syndrome (NMS): A rare but life-threatening reaction — high fever, severe muscle stiffness, confusion, and unstable heart rate and blood pressure. Stop the drug immediately and get emergency help.
  • Metabolic changes: Can raise blood sugar (sometimes severely), worsen cholesterol, and cause weight gain. Blood sugar and cholesterol should be monitored regularly.
  • Heart rhythm (QT prolongation): Asenapine can affect heart rhythm. Avoid other drugs that do the same, and tell your doctor about any heart conditions.
  • Low blood pressure when standing (orthostatic hypotension): Can cause dizziness or fainting, especially early in treatment or in older adults.
  • Low white blood cell count: May occur — your doctor may check blood counts if you have a history of this problem.
  • Seizures: Use with caution if you have a history of seizures.

Asenapine interactions

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Asenapine interacts with several medications that are worth knowing about before you start:

  • Blood pressure medications: Asenapine can add to blood-pressure-lowering effects — monitor carefully and adjust doses as needed.
  • Fluvoxamine (and other strong CYP1A2 inhibitors): Can raise asenapine levels in the blood, increasing the risk of side effects — a dose reduction may be needed.
  • Paroxetine: Asenapine can double paroxetine blood levels, so the paroxetine dose may need to be cut in half when both are used together.
  • QT-prolonging drugs: Combining asenapine with other medications that affect heart rhythm increases the risk of dangerous arrhythmias — avoid unless closely supervised.
  • Lithium and valproate: No meaningful effect on each other's blood levels — safe to use together as directed.

Interactions listed in the FDA-approved label

From the Asenapine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Antihypertensive drugs: Because of its α1-adrenergic antagonism with potential for inducing hypotension, asenapine may enhance the effects of certain antihypertensive agents. Monitor blood pressure and adjust dosage of antihypertensive drug accordingly.
  • Strong CYP1A2 inhibitors (e.g., fluvoxamine): Asenapine is metabolized by CYP1A2; a marginal increase of asenapine exposure was observed with fluvoxamine 25 mg twice daily, and a full therapeutic dose of fluvoxamine is expected to cause a greater increase. Dosage reduction for asenapine based on clinical response may be necessary.
  • CYP2D6 substrates and inhibitors (e.g., paroxetine): Asenapine may enhance the inhibitory effects of paroxetine on its own metabolism; paroxetine exposure increased by 2-fold compared to paroxetine alone. Reduce paroxetine dose by half when used in combination with asenapine.
  • Imipramine, cimetidine, valproate, lithium: No clinically important interaction; no dosage adjustment of asenapine is necessary.
  • CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin): No clinically important interaction; no dosage adjustment of asenapine is necessary.
Read the label’s full interactions text

7 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.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿122 supplements and herbs with documented Asenapine interactions, ranked by severity Check Asenapine against a supplement or herb →

Before taking Asenapine

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  • Severe liver disease (Child-Pugh C): Do not take asenapine — drug levels become dangerously high. This is a contraindication.
  • Known allergy to asenapine: Do not take — serious reactions including anaphylaxis, swollen tongue, and breathing difficulty have been reported.
  • Dementia-related psychosis: Asenapine is not approved for this use and carries a serious risk of death in elderly patients with this condition.
  • Pregnancy: Babies exposed in the third trimester may experience withdrawal symptoms or movement problems after birth. A pregnancy registry exists — ask your doctor for details.
  • Breastfeeding: It is unknown whether asenapine passes into human breast milk. Discuss the risks and benefits with your doctor.
  • Children under 10: Safety and efficacy have not been established.
  • Teens ages 10–17: Sublingual forms are approved for bipolar I disorder monotherapy in this age group, but not for schizophrenia.
  • Older adults: More sensitive to low blood pressure and other effects — monitor carefully. Not approved for dementia-related psychosis.
  • Kidney disease: No dose adjustment is needed for mild to severe kidney impairment.
  • History of seizures, heart rhythm problems, or low white blood cell counts: Tell your doctor before starting.

Asenapine overdose

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Taking too much asenapine can cause agitation and confusion, among other effects. There is no specific antidote — treatment focuses on supportive care, keeping the airway clear, and monitoring heart rhythm with an ECG (electrocardiogram). If you suspect an overdose, call Poison Control immediately at 1-800-222-1222 or seek emergency care.

What Asenapine does in the body

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Asenapine binds strongly to a wide range of receptors in the brain and body, acting as a blocker (antagonist) at dopamine D1, D2, D3, and D4 receptors, multiple serotonin receptor subtypes, alpha-adrenergic receptors (which influence blood pressure), and histamine H1 receptors (which can cause sedation). It has very little effect on muscarinic cholinergic receptors, which means it is less likely than some older antipsychotics to cause dry mouth, constipation, or urinary problems related to that pathway. This receptor profile shapes both its therapeutic effects and its side effects.

How your body processes Asenapine

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When taken as a sublingual tablet, asenapine is absorbed quickly, reaching peak blood levels within about 30 to 90 minutes. If swallowed instead of dissolved under the tongue, absorption drops dramatically — which is why it must dissolve in place. Asenapine has a half-life of roughly 24 hours, meaning the body takes about a day to clear half of each dose. It is broken down mainly by the liver (through an enzyme called CYP1A2 and a process called glucuronidation), and steady, stable blood levels are reached within about 3 days of twice-daily dosing. People with severe liver disease cannot clear it properly, making asenapine unsafe in that group.

How to store Asenapine

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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

122

Supplements & herbs that interact with Asenapine

122 supplements and herbal products have documented interactions with Asenapine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 78
  • Minor · 35
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major ARSENIC Major CESIUM Major EPHEDRA Major GRAPEFRUIT Major INDIAN SNAKEROOT Major RAUVOLFIA VOMITORIA Major +114 more
Every supplement checked against Asenapine — ranked by severity The full interaction hub: 9 major · 78 moderate · 35 minor · every one linked to its full report. Check Asenapine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Asenapine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Asenapine — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I have to let the tablet dissolve under my tongue instead of just swallowing it?

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Great question — this is actually really important. When you swallow asenapine, your body absorbs very little of it. Letting it dissolve under your tongue gets it into your bloodstream much more effectively. So skipping that step isn't just inconvenient — it means the medication won't work the way it's supposed to. Also, try not to eat or drink for 10 minutes after each dose, for the same reason.

My mouth feels numb after taking it — is that normal?

▾
Yes, numbness or tingling in the mouth is one of the most commonly reported side effects with the sublingual tablets, and it's generally harmless. It typically fades on its own. If it's really bothering you or doesn't go away, mention it to your doctor or pharmacist — they may have tips to help, or check whether your dose or timing can be adjusted.

What side effects should actually make me call my doctor right away?

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A few things are worth acting on quickly. If you notice repetitive, uncontrolled muscle movements you can't stop — especially in your face, tongue, or limbs — contact your doctor immediately. Also seek urgent help for high fever combined with severe muscle stiffness and confusion, a racing heart, difficulty breathing, or a badly swollen tongue. Those are signs of serious reactions that need prompt medical attention. Dizziness when you stand up is also worth mentioning, especially if it's making you unsteady.

I'm worried about weight gain — is that really a risk with this medication?

▾
It can be, yes. Weight gain and changes in blood sugar and cholesterol are known risks with this class of medication. Your doctor should check your blood sugar and cholesterol before you start and periodically while you're on it. Staying active and eating well can help, and your care team can work with you if changes are significant. Don't stop the medication on your own without talking to your prescriber first.

I'm pregnant — is it safe to keep taking asenapine?

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This is a conversation to have with your doctor as soon as possible. Babies born to people who took antipsychotic medications in the last three months of pregnancy can sometimes have temporary withdrawal or movement symptoms after birth. That doesn't mean you must stop — untreated mental health conditions during pregnancy also carry real risks. Your doctor can weigh both sides with you. There's also a pregnancy registry you can join to help researchers track outcomes: call 1-866-961-2388 for details.

Can I wear the Secuado patch while showering?

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Showering is fine while wearing Secuado. However, swimming and bathing haven't been studied, so those should be avoided while the patch is on. One thing that's really important: don't apply any heating pads or heat sources over the patch — heat causes the medication to be absorbed faster than intended, which can raise your blood levels to unsafe levels. If the patch starts peeling at the edges, just press it back down firmly.

Is Asenapine available over the counter?

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No. Asenapine is a prescription medicine: every Asenapine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Asenapine first available?

▾
The earliest FDA record we hold for Asenapine is from 2009: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Asenapine was first used.

Who makes Asenapine?

▾
7 companies currently list Asenapine products in the FDA's NDC Directory, including Breckenridge Pharmaceutical, Inc., Msn Laboratories Private Limited, Alembic Pharmaceuticals Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Asenapine on HelloPharmacist

📊Asenapine supplement interactions122 checked — ranked by severity 🌿Drug & Supplement CheckerAsenapine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Asenapine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Asenapine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Asenapine forms and strengths (how it comes)

Asenapine is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Sublingual tablet

Under the tongue
Brands Saphris
How this form is used
What it may be used for
  • Saphris and asenapine sublingual tablets are approved for schizophrenia in adults
  • Saphris and asenapine sublingual tablets treat bipolar I disorder (manic or mixed episodes) in adults
  • Saphris and asenapine sublingual tablets treat bipolar I disorder (acute manic or mixed episodes) as monotherapy in patients ages 10 to 17
  • Saphris and asenapine sublingual tablets are used alongside lithium or valproate for bipolar I disorder in adults
Important instructions
  • Saphris and asenapine sublingual tablets must be placed under the tongue and allowed to dissolve completely — do not swallow, chew, split, or crush
  • The tablet dissolves in saliva within seconds
  • Do not eat or drink anything for 10 minutes after taking Saphris or asenapine sublingual tablets
  • Saphris and asenapine sublingual tablets are taken twice daily — follow your prescriber's schedule
Available strengths 3 strengths
2.5 mg 5 mg 10 mg
42 FDA-listed product records ⓘ

Skin patch

Through the skin
Brands Secuado
How this form is used
What it may be used for
  • Secuado is approved for the treatment of schizophrenia in adults
Important instructions
  • Secuado is applied once daily to clean, dry, intact skin on the upper arm, upper back, abdomen, or hip
  • Wear each Secuado patch for exactly 24 hours, then replace it at a different site
  • Do not cut Secuado or apply heat sources (such as a heating pad) over the patch — heat raises drug levels in the blood
  • If Secuado causes burning or irritation, remove it and apply a new patch to a different site
Available strengths 6 strengths
3.8 mg/d ASENAPINE 3.8 mg/d 5.7 mg/d ASENAPINE 5.7 mg/d 7.6 mg/d ASENAPINE 7.6 mg/d
9 FDA-listed product records ⓘ

Tablet

By mouth
Available strengths 3 strengths
2.5 mg 5 mg 10 mg
7 FDA-listed product records ⓘ

Asenapine on the U.S. market: products, makers and brands

How Asenapine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

7 companies list 24 Asenapine product records with the FDA, mostly as sublingual tablet, skin patch, tablet; the earliest marketing or approval year on record is 2009. Brand names on the directory include Saphris, Secuado; the rest are generics.

3
Dose forms ⓘ
7
Labelers (makers, repackagers, distributors)
3
Brand names
24
FDA-listed product records ⓘ
2009
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Breckenridge Pharmaceutical, Inc.21%
Msn Laboratories Private Limited21%
Alembic Pharmaceuticals Inc.13%
Alembic Pharmaceuticals Limited13%
Allergan, Inc.13%
Noven Therapeutics, LLC13%
Other makers8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Asenapine is used (Medicaid data)

A general measure of how commonly Asenapine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Asenapine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

47,447
Medicaid prescriptions filled (Q1–Q4 2025)
$17.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Asenapine prescribed? Of the 1,601 medications we measure, Asenapine ranks #642 by Medicaid prescriptions — more than 60% of them.

Where Asenapine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #642 of 1,601
#637 Emtricitabine, Rilpivi... 48,910 Rx #638 Eplerenone 48,763 Rx #639 Sumatriptan Nasal 48,078 Rx #640 Darbepoetin Alfa Injec... 47,924 Rx #641 Sofosbuvir and Velpata... 47,731 Rx #642 Asenapine 47,447 Rx #643 Omeprazole / Sodium Bi... 47,423 Rx #644 Aprepitant 47,287 Rx #645 Neomycin, Polymyxin, a... 46,914 Rx #646 Capsaicin Topical 46,781 Rx #647 Bimatoprost 46,752 Rx

Utilization by Asenapine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg sublingual tablet is the most-dispensed Asenapine product — about 46% of these Medicaid prescriptions.

asenapine 10 MG Sublingual Tablet Most dispensed

21,860 Medicaid prescriptions (Q1–Q4 2025) 46% of Asenapine prescriptions shown $7.6M gross reimbursement (before rebates) ≈ $346 per prescription (gross)

Summed across the 5 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859975

asenapine 5 MG Sublingual Tablet

17,765 Medicaid prescriptions (Q1–Q4 2025) 37% of Asenapine prescriptions shown $6.3M gross reimbursement (before rebates) ≈ $354 per prescription (gross)

Summed across the 5 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 859981

asenapine 2.5 MG Sublingual Tablet

6,389 Medicaid prescriptions (Q1–Q4 2025) 13% of Asenapine prescriptions shown $2.1M gross reimbursement (before rebates) ≈ $321 per prescription (gross)

Summed across the 3 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1606337

24 HR asenapine 0.238 MG/HR Transdermal System

588 Medicaid prescriptions (Q1–Q4 2025) 1% of Asenapine prescriptions shown $854,858 gross reimbursement (before rebates) ≈ $1,454 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2261750

24 HR asenapine 0.158 MG/HR Transdermal System

471 Medicaid prescriptions (Q1–Q4 2025) <1% of Asenapine prescriptions shown $651,605 gross reimbursement (before rebates) ≈ $1,383 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2261741

24 HR asenapine 0.317 MG/HR Transdermal System

374 Medicaid prescriptions (Q1–Q4 2025) <1% of Asenapine prescriptions shown $545,282 gross reimbursement (before rebates) ≈ $1,458 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2261758

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Asenapine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 16 of 83 listed Asenapine NDCs with Medicaid activity.

Compare Asenapine products

A representative set of FDA-listed product records for Asenapine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 24 of 24 products — FDA National Drug Code Directory. See every product, package size and price: browse all 24 Asenapine NDCs →

Asenapine side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Asenapine — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Asenapine are sedation, suicide attempt, weight increased; about 48% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

8,667
Reports mentioning it
48%
Reported as serious
12
Distinct effects shown
Most reported effects
Sedation
706
Suicide Attempt
666
Weight Increased
565
Inappropriate Schedule Of Drug Administration
564
Dyskinesia
534
Dystonia
522
Blood Glucose Increased
485
Sexual Dysfunction
437
Anosognosia
426
Akathisia
416
Age groups
Adult · 401Elderly · 25Adolescent · 6Child · 5Neonate · 3

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Asenapine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Asenapine FDA approval history

How Asenapine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Asenapine was first approved by the FDA in 2009 (Brand: SAPHRIS · Abbvie); the first generic version was approved in 2020. It remains available in U.S. pharmacies today.

2009
Brand approved
Brand: SAPHRIS · Abbvie
2020
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Asenapine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Asenapine recalls since July 2021.

✅No Asenapine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Asenapine RxCUI 784649 2 dose forms · 6 strengths
  1. Dose form (SCDF) Sublingual Tablet RxCUI 859974 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG RxCUI 1606337 5 MG RxCUI 859981 10 MG RxCUI 859975

Look up RxCUI 784649 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Asenapine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Sublingual 5 mg $21.16 per tablet NDC details & price history
Tablet · Sublingual 10 mg $21.16 per tablet NDC details & price history
Tablet · Sublingual 2.5 mg $20.99 per tablet NDC details & price history
Film, Extended Release · Transdermal 3.8 mg/d $49.07 each NDC details & price history
Film, Extended Release · Transdermal 5.7 mg/d $49.05 each NDC details & price history
Film, Extended Release · Transdermal 7.6 mg/d $48.83 each NDC details & price history
Film, Extended Release · Transdermal ASENAPINE 3.8 mg/d $49.07 each NDC details & price history
Film, Extended Release · Transdermal ASENAPINE 5.7 mg/d $49.05 each NDC details & price history
Film, Extended Release · Transdermal ASENAPINE 7.6 mg/d $48.83 each NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Asenapine brand names

Asenapine is sold under 2 brand names in the FDA directory — Saphris, Secuado. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Saphris Secuado

Who makes Asenapine: manufacturers and labelers

7 companies list Asenapine products with the FDA. By number of product records, the largest are Breckenridge Pharmaceutical, Inc., Msn Laboratories Private Limited, Alembic Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Breckenridge Pharmaceutical, Inc. 5 Msn Laboratories Private Limited 5 Alembic Pharmaceuticals Inc. 3 Alembic Pharmaceuticals Limited 3 Allergan, Inc. 3 Noven Therapeutics, LLC 3 Sigmapharm Laboratories, LLC 2

Asenapine drug class (RxNorm)

Asenapine belongs to the Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Diazepines, oxazepines, thiazepines and oxepines

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Asenapine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 25, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Asenapine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Asenapine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
6
Finished products in the current FDA directory
24
Companies listing them (makers, repackagers, distributors)
7
FDA labeler codes behind them ⓘ
7
Linked representative label ⓘ
Alembic Pharmaceuticals Inc.
Linked label effective
Feb 25, 2025
Composite sections available
25
Linked SPL Set ID
16e1cc9f-7699-49ea-b179-acb65e162304
Linked SPL Document ID
d54a0a82-b197-46eb-9c1d-4e77960d6f60
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Alembic Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →