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Asenapine oromucosal

Updated 2 Feb 2023 | Asenapine


Sublingual tablets containing asenapine

Drugs List

  • asenapine 10mg sublingual tablets sugar-free
  • asenapine 5mg sublingual tablets sugar-free
  • SYCREST 10mg sublingual tablets
  • SYCREST 5mg sublingual tablets
  • Therapeutic Indications


    Treatment of manic episodes associated with bipolar disorder

    Treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.



    Initially 10 mg twice daily with one dose taken in the morning and one dose in the evening.
    The dose may be reduced to 5 mg twice daily according to clinical assessment.

    Combination therapy:
    Initially 5 mg twice daily with one dose taken in the morning and one dose in the evening.
    The dose may be increased to 10 mg twice daily depending on the clinical response and tolerability.


    Children under 18 years
    Renal impairment - creatinine clearance below 15ml/minute
    Severe hepatic impairment

    Precautions and Warnings

    Family history of long QT syndrome
    Patients over 65 years
    Predisposition to hypotension
    Cardiovascular disorder
    Cerebrovascular disorder
    Diabetes mellitus
    Epileptic disorder
    History of seizures
    Moderate hepatic impairment
    Parkinson's disease

    Patients at risk of suicide should be closely supervised
    Advise ability to drive/operate machinery may be affected by side effects
    Advise patients not eat immediately after a dose
    Monitor ECG in patients at risk of QT prolongation
    Monitor patients with existing or tendency towards diabetes mellitus
    Neonate exposed in utero: Monitor neonate for adverse effects
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Consider discontinuation if signs of tardive dyskinesia occur
    Dysphagia & aspiration:caution in patients at risk for aspiration pneumonia
    May cause postural hypotension especially in elderly
    May impair ability to reduce core body temperature
    Discontinue if patient develops neuroleptic malignant syndrome
    Advise patient to avoid alcohol during treatment

    Elderly patients with psychosis related to dementia, treated with antipsychotic substances, are at an increased risk of death.

    Patients with Parkinson's disease or dementia with Lewy Bodies are at increased risk of Neuroleptic Malignant Syndrome and increased sensitivity to antipsychotics.

    Pregnancy and Lactation


    Use asenapine with caution in pregnancy.

    Use of asenapine during pregnancy is recommended by the manufacturer only if the benefits to the mother outweigh the potential risk to the foetus. There are no adequate data from the use of asenapine in pregnant women.

    In animal studies asenapine did not impair fertility in rats and was not found to be teratogenic in rats and rabbits. Embryotoxic effects were, however, found in reproduction toxicology studies using rats and rabbits and asenapine caused mild maternal toxicity and slight retardation of foetal skeletal development.

    Neonates exposed to antipsychotics during the third trimester of pregnancy are at risk of adverse reactions. Monitor neonates carefully for extrapyramidal and/or withdrawal symptoms.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Asenapine is contraindicated while breastfeeding.

    Studies in rats have shown asenapine to be excreted in milk during lactation. It is not known if asenapine or its metabolites are excreted in human milk.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at


    The sublingual tablet should be placed under the tongue and allowed to dissolve completely. The tablet will dissolve in saliva within seconds. The sublingual tablets should not be crushed, chewed or swallowed.

    Advise the patient to avoid eating and drinking for 10 minutes after administration.

    If using in combination with other medication then asenapine should be taken last.

    Advise the patient to avoid alcohol.

    Advise patient to report unexplained fever, sore throat, bruising or bleeding.

    Advise the patient not to drive or operate machinery if affected by certain side effects of asenapine such as sleepiness.

    Side Effects

    Allergic reaction
    Anaphylactic reaction
    Bundle branch block
    Exacerbation of diabetes
    Extrapyramidal effects
    Hypersensitivity reactions
    Increased appetite
    Increases in hepatic enzymes
    Mouth inflammation
    Muscle rigidity
    Neuroleptic malignant syndrome
    Oral hypoaesthesia
    Oral mucosal blistering
    Oral paraesthesia
    Oral ulceration
    Orthostatic hypotension
    Prolongation of QT interval
    Pulmonary embolism
    Restless legs
    Sexual dysfunction
    Sinus bradycardia
    Sinus tachycardia
    Throat swelling
    Tongue swelling
    Visual disturbances
    Weight gain


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2013

    Reference Sources

    British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Sycrest 5mg sublingual tablets & Sycrest 10mg sublingual tablets. Lundbeck. Revised February 2013.

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