Asenapine (Saphris).

• Common Brand Name(s): Saphris®, Secuado® (Extended-release transdermal patch)
• Common Generic Name(s): Asenapine
• Pronunciation: a-SEN-a-peen
• Drug class: Atypical antipsychotics

What is Asenapine (Saphris)?

Asenapine is administered as a sublingual tablet. Potential side effects include restlessness, oral numbness, drowsiness, and dizziness. Due to possible effects on alertness and coordination, exercise caution. To prevent overheating, ensure adequate hydration and wear breathable attire.

Side Effects of Asenapine (Saphris)

Asenapine may cause a range of side effects, including drowsiness, insomnia, restlessness, fatigue, headaches, and temporary numbness of the mouth or tongue. It can also lead to metabolic changes such as weight gain, increased glucose, and cholesterol abnormalities, and some individuals may experience movement-related side effects. If using the transdermal system, skin reactions at the application site are possible; to minimize this, it’s crucial to rotate application sites daily.

Common Side Effects:

• Drowsiness
• Insomnia
• Restlessness
• Fatigue
• Headaches
• Temporary numbness of the mouth or tongue

Serious Side Effects:

• Breathing problems or wheezing
• Racing heart
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Trouble swallowing or throat tightness
• Itching, skin rash, or pale red bumps on the skin called hives
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain

If you experience severe side effects, contact your doctor immediately.

Conditions Treated with Asenapine (Saphris)

Asenapine (Saphris) is FDA-approved for the treatment of:

Common Off-Label Uses

While Asenapine (Saphris) is not FDA-approved for these conditions, healthcare providers may sometimes prescribe it off-label based on clinical judgment and emerging research. Common off-label uses may include:

Dosage

Asenapine (Saphris) is a sublingual tablet that must be placed under the tongue and allowed to dissolve completely. Do not eat or drink for 10 minutes after taking the tablet. Dosage varies based on the condition being treated, patient age, and individual response.

Missed Dose

If you miss a dose of Asenapine (Saphris), take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. Consult your doctor or pharmacist if you are unsure.

Questions to Ask Your Doctor About Asenapine 

• Is Saphris the right medication for my condition?

• What are the potential benefits and risks of taking Saphris?

• How should I take Saphris sublingual tablets correctly?

• What should I do if I miss a dose?

• What are the common side effects I might experience, and how can I manage them?

• What are the serious side effects I need to watch out for, and when should I seek immediate medical attention?

• What medications, supplements, or herbal products should I avoid while taking Saphris?

• Will Saphris interact with any of my existing medical conditions?

• How often will I need to have follow-up appointments and blood tests while on this medication?

• Can I drink alcohol while taking Saphris?

• How will Saphris affect my ability to drive or operate machinery?

• What are the signs of overdose, and what should I do if it occurs?

• What should I know about stopping Saphris, and what are the risks of sudden discontinuation?

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If you or a loved one is struggling with a condition requiring aripiprazole, professional help is available.

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Frequently Asked Questions

Disclaimer: This content is for informational purposes only and is not intended to diagnose, treat, or substitute professional medical advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you are experiencing a mental health crisis, seek immediate medical attention or call emergency services.

Asenapine FDA Drug Fact Sheet