Asenapine

SGA / Sublingual·Psychiatry - Oral Antipsychotics

Bipolar I disorder (acute mania/mixed episodes), Schizophrenia

Authority requiredPBSSGASaphris5 mg+2

Max Dose

20 mg/day

Half-life

24 h

Route

SUBLINGUAL ONLY

Fasting

10 MINS POST DOSE

Rapid Summary

Overview

Sublingual-only SGA. Highly effective for acute mania. Cannot be swallowed due to total destruction by liver first-pass metabolism.

Maximum Dose

Max 20 mg/day (10 mg BD).

Clinical Focus

The patient must NOT eat or drink for 10 minutes after the wafer dissolves, or the drug will wash into the stomach and be rendered useless.

Bottom Line

Asenapine is a sublingual atypical antipsychotic for schizophrenia and bipolar mania, but must be dissolved sublingually (not swallowed) and causes oral hypoaesthesia and taste disturbance.

Formulation & Access

Brand Names

Saphris

Oral Routes

Sublingual Wafers (5 mg, 10 mg). Black cherry flavor.

Prescribing & PBS

Authority Required (PBS).

Indications & Use

Primary

PBSTGA

Bipolar I disorder (acute mania/mixed episodes), Schizophrenia.

Clinical Place

Rapid acting for acute mania. Good alternative if patients struggle with swallowing tablets or require rapid absorption without an injection.

Quick reference

Class & Role

SGA / Sublingual — Sublingual-only SGA.

Route / Formulation

Sublingual Wafers (5 mg, 10 mg). Black cherry flavor. (Saphris)

Usual Dose & Max

SL 5-10 mg BD. Place under tongue and allow to dissolve completely. Max 20 mg/day (10 mg BD).

Key Indication Doses

Bipolar Mania / Schizophrenia: SL 5-10 mg BD. Place under tongue and allow to dissolve completely. Administration Rule: Do not chew, crush, or swallow. Nil By Mouth for 10 minutes post-dose.

Best Uses

Asenapine is a sublingual atypical antipsychotic for schizophrenia and bipolar mania, but must be dissolved sublingually (not swallowed) and causes oral hypoaesthesia and taste disturbance.

Avoid / Cautions

Severe hepatic impairment. Pregnancy Category C.

Key Risks

Neurological: Somnolence, sedation, akathisia, EPS. Gastrointestinal: Oral hypoesthesia (numbness of the tongue/mouth), dysgeusia (bad taste). Metabolic: Weight gain (less than Olanzapine, more than Aripiprazole).

Key Interactions

CYP1A2 inhibitors (Fluvoxamine, Ciprofloxacin) significantly increase asenapine levels. Additive sedation with CNS depressants and hypotension with antihypertensives.

Monitoring

Supervise administration. Psychiatric patients frequently swallow the wafer or immediately drink water to wash the bad taste away, which guarantees the drug will fail. They must hold it under the tongue. Baseline BSL and Lipids.

Clinical Pearl

Warn the patient that their tongue will feel numb or tingle after the wafer dissolves. This is a local anesthetic-like effect of the drug molecule itself, not an allergic reaction. It fades in 30 minutes.

Access

Authority requiredSaphris5 mg

Brand: Saphris
PBS status: Authority required
Formulation: Sublingual Wafers (5 mg, 10 mg)

Asenapine

SGA / Sublingual·Psychiatry - Oral Antipsychotics

Bipolar I disorder (acute mania/mixed episodes), Schizophrenia

Authority requiredPBSSGASaphris5 mg+2

Max Dose

20 mg/day

Half-life

24 h

Route

SUBLINGUAL ONLY

Fasting

10 MINS POST DOSE

Rapid Summary

Overview

Sublingual-only SGA. Highly effective for acute mania. Cannot be swallowed due to total destruction by liver first-pass metabolism.

Maximum Dose

Max 20 mg/day (10 mg BD).

Clinical Focus

The patient must NOT eat or drink for 10 minutes after the wafer dissolves, or the drug will wash into the stomach and be rendered useless.

Bottom Line

Asenapine is a sublingual atypical antipsychotic for schizophrenia and bipolar mania, but must be dissolved sublingually (not swallowed) and causes oral hypoaesthesia and taste disturbance.

Formulation & Access

Brand Names

Saphris

Oral Routes

Sublingual Wafers (5 mg, 10 mg). Black cherry flavor.

Prescribing & PBS

Authority Required (PBS).

Indications & Use

Primary

PBSTGA

Bipolar I disorder (acute mania/mixed episodes), Schizophrenia.

Clinical Place

Rapid acting for acute mania. Good alternative if patients struggle with swallowing tablets or require rapid absorption without an injection.

Quick reference

Class & Role

SGA / Sublingual — Sublingual-only SGA.

Route / Formulation

Sublingual Wafers (5 mg, 10 mg). Black cherry flavor. (Saphris)

Usual Dose & Max

SL 5-10 mg BD. Place under tongue and allow to dissolve completely. Max 20 mg/day (10 mg BD).

Key Indication Doses

Bipolar Mania / Schizophrenia: SL 5-10 mg BD. Place under tongue and allow to dissolve completely. Administration Rule: Do not chew, crush, or swallow. Nil By Mouth for 10 minutes post-dose.

Best Uses

Asenapine is a sublingual atypical antipsychotic for schizophrenia and bipolar mania, but must be dissolved sublingually (not swallowed) and causes oral hypoaesthesia and taste disturbance.

Avoid / Cautions

Severe hepatic impairment. Pregnancy Category C.

Key Risks

Key Interactions

CYP1A2 inhibitors (Fluvoxamine, Ciprofloxacin) significantly increase asenapine levels. Additive sedation with CNS depressants and hypotension with antihypertensives.

Monitoring

Clinical Pearl

Access

Authority requiredSaphris5 mg

Brand: Saphris
PBS status: Authority required
Formulation: Sublingual Wafers (5 mg, 10 mg)