Asenapine is an antipsychotic medication primarily used in the treatment of schizophrenia and bipolar disorder. It is important to inform your doctor of any medication you use (prescribed and over the counter) before starting asenapine treatment, as adverse effects can occur.
Asenapine brand names
- Saphris
- Secuado
What is asenapine prescribed for?
Asenapine is FDA-approved to treat [1]:
- Schizophrenia in adults: to manage acute symptoms or as a maintenance treatment
- Bipolar disorder in ages 10 and above: to treat manic or mixed episodes
- Bipolar disorder in adults: either as the only medication or alongside a mood stabilizer such as lithium or valproate
Additionally, asenapine can be used off-label to treat symptoms such as agitation [2].
In 2019, a transdermal patch was approved for use by the FDA only for the treatment of schizophrenia in adults. It is applied to the skin, and the medication is absorbed. This is intended to help with medication compliance and allow for ease of administration [3][4].
How does asenapine work?
Asenapine is an atypical or second-generation antipsychotic medication. It works by blocking receptors in the brain, preventing the reuptake of dopamine, serotonin, and norepinephrine. This helps to regulate the levels and activity of these neurotransmitters [5].
Regulating dopamine activity is believed to help reduce the positive symptoms of schizophrenia, such as hallucinations and delusions, and reduce symptoms of mania in bipolar disorder. By impacting serotonin levels, asenapine has an antidepressant effect, helping to reduce negative symptoms of schizophrenia and depressive episodes in bipolar disorder [2][6].
It is believed that the regulation of norepinephrine also contributes to improvements in negative and cognitive symptoms of schizophrenia [5].
Although similar to other atypical antipsychotic drugs, asenapine may be less likely to cause weight gain, anticholinergic effects, and metabolic syndrome [4][5].
How is asenapine usually taken?
Asenapine is available as a sublingual tablet in 2.5mg, 5mg, and 10mg strengths, and as a transdermal patch, in 3.8mg, 5.7mg, and 7.6mg strengths.
For individuals taking the tablet: The sublingual tablet must be removed from the packaging with dry hands and only immediately prior to use. It should not be removed from the packaging and stored in another container [7].
The tablet should be placed under the tongue and left to dissolve, which takes several seconds. Following this, wait 10 minutes before eating or drinking anything.
For the treatment of schizophrenia and bipolar disorder in adults, individuals are typically started with a dose of 5mg twice per day, which can be increased after one week to 10mg twice per day if necessary.
For the treatment of bipolar disorder in pediatric individuals, the starting dose is typically lower, at 2.5mg twice per day. This is intended to help prevent adverse effects. The dose can be increased if required to 5mg twice daily after three days and 10mg twice daily after another three days [1].
For individuals using the patch: The transdermal patch should be removed from the packaging and, without cutting or tearing, placed directly onto the skin on the upper arm, upper back, hip, or stomach area. The patch should remain in place for 24 hours, after which a new patch should be applied. Each patch should be applied to a different location from the previous one to help prevent skin irritation [8].
For the treatment of schizophrenia in adults, individuals are initially prescribed one 3.8mg patch per 24 hours. This can be increased if required to 5.7mg or 7.6mg per day after one week [3].
This medication should be taken exactly as prescribed, as taking too much or missing doses can increase the risk of adverse reactions and may cause a worsening of your condition. If a dose is missed, do not take double the following dose. Skip the missed dose and take the next one at the specified time.
How long does asenapine stay in your system?
When beginning asenapine treatment, it may take up to three months before the medication takes full effect. Changes in mental state may be noticed within the first few weeks. It is important to continue taking your medication consistently, to ensure it reaches its full therapeutic effect [7].
If and when asenapine treatment is stopped, it may take several days or weeks after the final dose before the medication is out of your system entirely [1][3].
Asenapine should not be suddenly stopped, as this can cause withdrawal symptoms. If it is safe to come off this medication, your doctor will gradually reduce your prescription to prevent these effects.
Many patients with schizophrenia or bipolar disorder require life-long treatment to manage their symptoms, so it may be necessary to use this medication long-term [7].
Asenapine side effects
When beginning a new treatment, side effects may occur. These effects often emerge within the first few weeks and then reduce without professional intervention. However, you should contact your doctor if side effects persist or become concerning, as you may need a change of medication or dosage.
Common side effects of asenapine can include [7][8]:
- Drowsiness
- Dizziness
- Agitation
- Restlessness
- Fatigue
- Headache
- Insomnia
- Dry mouth
- Stomach pain
- Nausea and vomiting
- Aches in the joints or limbs
- Increased saliva
- Anxiety
- Depression
- Irregular or stopped menstruation
- Milk production in males and females
- Sexual dysfunction, such as decreased libido
- Unpleasant or unusual taste in the mouth (tablet)
- Numbness in the mouth (tablet)
- Skin irritation (patch)
In some cases, serious side effects may occur. If you experience any of the following side effects when taking asenapine, contact your doctor immediately [7][8]:
- Fever
- Confusion
- Increased blood sugar
- Irregular or rapid heart rate
- Uncontrollable or jerky movements in the muscles or face
- Persistent muscle stiffness, pain, or tremors
- Excessive sweating
- Excessive thirst and urination
- Blurred vision
- Breathing difficulties
- Seizures
Asenapine precautions
Older adults
Antipsychotic medications, including asenapine, can cause an increased risk of stroke and sudden death in older adults and elderly patients. Because of this risk, asenapine is not approved to treat dementia psychosis [1][3].
Neuroleptic malignant syndrome
Neuroleptic malignant syndrome (NMS) is a rare condition that can be caused by antipsychotic medications, such as asenapine. NMS can be fatal, so contact your doctor immediately for appropriate medical attention if symptoms emerge. Symptoms of NMS can include [7]:
- Extremely high body temperature
- Change in mental state
- Extreme muscle rigidity
- Significant changes in heart rate or blood pressure
- Confusion
Tardive dyskinesia
Tardive dyskinesia (TD) is a movement condition that can be caused by antipsychotic use. The risk of TD increases with higher doses and longer durations of use, although it can occur early in treatment or with low doses.
TD can cause irreversible effects. In some cases, symptoms can be stopped by discontinuing medication; in others, they may continue even after medication has been stopped [1].
If symptoms of TD emerge, contact your doctor. They may suggest discontinuing your medication, although it may be necessary to continue treatment in some cases. Symptoms of TD include uncontrollable movements of the limbs or in the face, such as lip smacking and grimacing [7].
Metabolic syndrome
Antipsychotic medications can cause metabolic syndrome. Asenapine is found to be less likely to cause this, although it can still occur. Metabolic changes caused by asenapine can include excessive weight gain, increased blood sugar, and diabetes. Your prescribing doctor will likely monitor your weight and blood sugar throughout your treatment to manage this risk [2][8].
Health history
Due to the potential side effects, asenapine may be unsafe for individuals with a history or high risk of heart conditions, liver disease, seizures, low white blood cell count, stroke, or breast cancer. If this medication is required, you may be prescribed a reduced dose, and your doctor or healthcare provider will likely ensure careful monitoring of your physical health throughout treatment [8].
Pregnancy and breastfeeding
Inform your doctor if you are pregnant or planning to become pregnant before starting asenapine treatment. There may be some risk of withdrawal symptoms and side effects in newborns when asenapine is used during pregnancy, particularly in the third trimester. Although, it is important to be aware of these risks, it also important to discuss the potential harm to mother and baby of untreated schizophrenia [7].
It is currently unclear if asenapine is excreted in breast milk, so it is advised not to use this medication while breastfeeding to prevent harm to the infant. Again, you should discuss this with your doctor so you can make an informed decision about your treatment [1].
Body temperature
Asenapine can impair body temperature regulation. As such, it is advised to be careful of prolonged exposure to sunlight or when exercising, as it may take longer for body temperature to return to normal [3].
Drowsiness and dizziness
Asenapine can cause drowsiness, so you should not drive until you know how the medication impacts you.
Additionally, asenapine can cause a risk of dizziness and fainting, particularly when standing from a seated or lying position, so it is advised to be cautious when rising [8].
Tablet use
After taking asenapine sublingual tablets, you must ensure that you do not eat or drink anything for 10 minutes, as this can impact the effectiveness of the medication [1].
Asenapine interactions
Asenapine can interact with other substances and medications, which may cause an increased risk of side effects or a reduction in the effectiveness of your medication.
This includes other antipsychotics, heart medications, antidepressants, antibiotics, antihistamines, medication for Parkinson’s disease, glaucoma, or urinary conditions, anticonvulsants, sedatives, and tranquilizers [1][8].
Always discuss your medications with your doctor before starting a new treatment.
It is advised to avoid or limit alcohol consumption when taking asenapine, as alcohol can increase the sedating effects of the medication and the risk of side effects [7].
Asenapine storage
Always store medications in a safe place and out of reach of children.
Asenapine sublingual tablets and transdermal patches must be kept in their original packaging, at room temperature, and away from dampness or humidity.
If medications are no longer needed or are out of date, contact a pharmacist or medical professional for safe disposal. Do not put tablets in the bin or toilet, as this creates unnecessary risks. After removing the transdermal patch, fold it so the adhesive side is stuck together. Immediately put it in the trash and wash your hands [3].
What to do if you overdose on asenapine
If you overdose on asenapine, call Poison Control or a medical professional. In case of an emergency, call 911. Symptoms of an asenapine overdose can include agitation and confusion [1][3].
- Allergan USA, Inc. (Revised 2017). Saphris (Asenapine) Sublingual Tablets. FDA. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022117s020s021lbl.pdf
- Musselman, M., Faden, J., & Citrome, L. (2021). Asenapine: An Atypical Antipsychotic with Atypical Formulations. Therapeutic Advances in Psychopharmacology, 11. Retrieved from https://doi.org/10.1177/20451253211035269
- Noven Therapeutics, LLC. (2019). Secuado (Asenapine) Transdermal System. FDA. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212268s000lbl.pdf
- Zhou, M., Derakhshanian, S., Rath, A., Bertrand, S., DeGraw, C., Barlow, R., Menard, A., Kaye, A.M., Hasoon, J., Cornett, E.M., Kaye, A.D., Viswanath, O., & Urits, I. (2020). Asenapine Transdermal Patch for the Management of Schizophrenia. Psychopharmacology Bulletin, 50(4), 60–82. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7511145/
- Balaraman, R., & Gandhi, H. (2010). Asenapine, A New Sublingual Atypical Antipsychotic. Journal of Pharmacology & Pharmacotherapeutics, 1(1), 60–61. Retrieved from https://doi.org/10.4103/0976-500X.64538
- O’Connor, F.L. (1998). The Role of Serotonin and Dopamine in Schizophrenia. Journal of the American Psychiatric Nurses Association, 4(4), S30-S34. Retrieved from https://doi.org/10.1016/S1078-3903(98)90006-4
- The American Association of Psychiatric Pharmacists (AAPP) and the National Alliance on Mental Illness (NAMI). (2023). Asenapine (Saphris).NAMI. Retrieved from https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Types-of-Medication/Asenapine-(Saphris)
- National Library of Medicine. (Revised 2017). Asenapine. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a610015.html
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