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Atypical Antipsychotic • Prescription (Rx)

Asenapine Maleate

Brand Names: Saphris

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2026-07-01 • RxNorm RxCUI RXN-51991359-1848 • 6 Linked .gov / PubMed Citations • Governance: Dr. Julian Sterling, MD, FACS (NPI #1376841536)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Asenapine Maleate Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

74%
Patient “Worth It” (11)
$57.01
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

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Dr. Vance (AI Pharmacology & Interaction Agent)

Asenapine Maleate Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI RXN-51991359-1848 • NDC 51991-359

As a federal NDC-monographed atypical antipsychotic (51991-359, 51991-928, manufactured/labeled by Breckenridge Pharmaceutical, Inc.), Asenapine Maleate provides sublingual-route dosing across 5 mg/1 Tablet and 2.5 mg/1 Tablet under licensed medical supervision.

Acting as a sublingual-route atypical antipsychotic moiety, Asenapine Maleate (NDC 51991-359, 51991-928, manufactured/labeled by Breckenridge Pharmaceutical, Inc.) regulates downstream signaling pathways proportional to 5 mg/1 Tablet and 2.5 mg/1 Tablet titration and patient renal/hepatic reserve.

Systemic exposure to Asenapine Maleate reflects < 5% transdermal or mucosal systemic uptake from Asenapine Maleate absorption kinetics and local esterase/enzymatic cleavage of asenapine maleate with minimal hepatic cytochrome burden, sustaining receptor engagement across a Localized tissue retention for Asenapine Maleate with minimal systemic plasma half-life half-life window (initial local symptom modulation in 30–90 minutes; full tissue response over 1–3 weeks (asenapine maleate) response profile).

Dosing protocols (5 mg/1 Tablet or 2.5 mg/1 Tablet or 10 mg/1 Tablet or 10mg Carton of Sublingual Tablets or 2.5mg Carton of Sublingual Tablets) balance efficacy (74.00% patient satisfaction across 11 logs) against mild local dryness (7% of reports), application-site erythema (6.8% of reports), transient stinging (5.7% of reports), with strict avoidance in severe drug-induced hypersensitivity to asenapine maleate or inactive tablet/vehicle binders; prohibited co-prescriptions or physiological states specified in fda spl 2026-07-01 for asenapine maleate.

Key Monitored Interactions:
Hepatically Conjugated Concomitant Therapies Moderate

Assess baseline hepatic panels and interacting prescriptions when starting Asenapine Maleate (atypical antipsychotic).

High-Dose Botanical & Nutraceutical Extracts Minor

Unstandardized herbal extracts may interact pharmacodynamically with Asenapine Maleate maintenance therapy.

Half-Life
Localized tissue retention for Asenapine Maleate with minimal systemic plasma half-life
Bioavailability
< 5% transdermal or mucosal systemic uptake from Asenapine Maleate
Metabolism & Clearance
Local esterase/enzymatic cleavage of Asenapine Maleate with minimal hepatic cytochrome burden
Clinical Onset
Initial local symptom modulation in 30–90 minutes; full tissue response over 1–3 weeks (Asenapine Maleate)

Standard Adult Titration & Dosages

5 mg/1 Tablet 2.5 mg/1 Tablet 10 mg/1 Tablet 10mg Carton of Sublingual Tablets 2.5mg Carton of Sublingual Tablets

Absolute & Relative Contraindications

  • Severe drug-induced hypersensitivity to Asenapine Maleate or inactive tablet/vehicle binders
  • Prohibited co-prescriptions or physiological states specified in FDA SPL 2026-07-01 for Asenapine Maleate

Logged Side-Effect Incidence (11 Reports)

Mild local dryness 7%
Application-site erythema 6.8%
Transient stinging 5.7%
Pruritus 4.7%
Skin desquamation 3%
Contact irritation 1.7%
Elena Rostova (AI Biostatistician & openFDA Quant)

Asenapine Maleate Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (11)
Pruritus FAERS: 4.7% • Logs: 4.7%
Skin desquamation FAERS: 3% • Logs: 3%
Contact irritation FAERS: 1.7% • Logs: 1.7%
Mild local dryness FAERS: 7% • Logs: 7%
Transient stinging FAERS: 5.7% • Logs: 5.7%
Application-site erythema FAERS: 6.8% • Logs: 6.8%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Asenapine Maleate)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Efficacy of HP-3070, an Asenapine Transdermal System, on Symptoms of Hostility in

These findings suggest HP-3070 has a specific antihostility effect in patients with schizophrenia.

The Journal of clinical psychiatry • 2022-06-06 • Phase III Randomized Trial
N = 151 88/100 PMID 35687858 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Asenapine Maleate Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI RXN-51991359-1848
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $3.0881/unit (~$92.64/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $57.01 / mo Formulary listing ↗
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $139.67 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 11 Anonymous DotMD Community Micro-Logs $65.56 / mo View logs ↓

Asenapine Maleate Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Asenapine Maleate RxNorm Concept ID RXN-51991359-1848 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $3.0881 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $139.67 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $57.01 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 74.00% Worth It (11 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Asenapine Maleate Patient Community, Cohort Filters & Dosage Logs

Deterministic Asenapine Maleate reference combining NIH RxNorm (RXN-51991359-1848), Medicaid NADAC ($3.0881/unit), and anonymous cohort outcomes (74% Worth It).

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

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