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asenapine

Sycrest · ATC code N05AH05

Also known as: Asenapin

Key facts
Active substance
asenapine
Drug class
Antipsychotics
ATC code
N05AH05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Sycrest 5 mg sublingual tablets · Sycrest 10 mg sublingual tablets
Marketing authorisation holder
Organon N.V.
Information as of
2026-10-27

Key facts

Asenapine (Sycrest) is an antipsychotic given as sublingual tablets. It is used in adults for moderate to severe manic episodes associated with bipolar I disorder.

What it is used for

  • Moderate to severe manic episodes associated with bipolar I disorder in adults
  • Not indicated in children and adolescents below 18 years

Dosing

  • Monotherapy and combination therapy: start 5 mg twice daily (morning and evening); may increase to 10 mg twice daily based on response and tolerability
  • Place the tablet under the tongue and let it dissolve completely; avoid eating and drinking for 10 minutes afterwards
  • No dose adjustment in renal impairment; no experience with creatinine clearance less than 15 mL/min
  • Moderate hepatic impairment: caution; severe hepatic impairment: not recommended
  • Elderly patients: use with care

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Elderly patients with dementia-related psychosis: increased risk of death with antipsychotics; not recommended
  • Neuroleptic malignant syndrome: discontinue if signs develop
  • Seizures; caution with a history of seizure disorder
  • Orthostatic hypotension, hyperglycaemia; caution with cardiovascular disease or family history of QT prolongation
  • Serious hypersensitivity reactions (anaphylaxis, angioedema, swollen tongue and throat)

Side effects

  • Most frequent: somnolence and anxiety
  • Weight increased, increased appetite, dystonia, akathisia, parkinsonism, sedation, dizziness, dysgeusia
  • Oral hypoaesthesia and paraesthesia directly after administration, usually resolving within 1 hour
  • Rarely neuroleptic malignant syndrome, seizures

Interactions

  • Caution with other centrally acting medicines; avoid alcohol
  • Fluvoxamine (CYP1A2 inhibitor) causes clinically relevant changes in asenapine pharmacokinetics
  • Caution with medicines thought to prolong the QT interval

Pregnancy and breastfeeding

  • No adequate data in pregnant women
  • Newborns exposed in the third trimester are at risk of extrapyramidal and/or withdrawal symptoms; monitor carefully

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • SycrestOrganon N.V. · EMEA/H/C/001177

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Sycrest
Liechtenstein
Sycrest
Norway
Sycrest

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Sycrest – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/sycrest-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC N05AH.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.