Indications  

Saphris is a prescribed medication indicated for treating schizophrenia in adults and managing bipolar I disorder.  

For bipolar I disorder, this medication can be used as acute monotherapy for manic or mixed episodes in adults and pediatric patients aged 10 to 17 years, as adjunctive treatment to lithium or valproate in adults, and as maintenance monotherapy in adults. 

As an atypical antipsychotic, Saphris functions by aiding in the restoration of the balance of specific natural substances in the brain, known as neurotransmitters. 

Uses and Dosage 

Before starting treatment with Saphris and with each prescription refill, carefully review its medication guide and patient information leaflet. If you have any concerns, do not hesitate to seek advice from your doctor or pharmacist. 

The dosage of this medication may vary per individual based on medical condition, response to the treatment, and concurrent medications. 

Saphris is a sublingual tablet meant to dissolve under the tongue, typically taken twice daily as prescribed by the doctor. 

To properly take this medication, follow these steps: 

1. Keep the tablets in the package until you are prepared to take them.  
   • Ensure your hands are dry before handling the tablets. 
2. When you are ready to take the tablet, carefully follow the package instructions to remove the tablet from the case.  
   • Do not push the tablet through the pack or attempt to break it. 
3. Place the tablet under your tongue and allow it to dissolve.  
   • Refrain from swallowing, splitting, chewing, or crushing the tablet. 
4. After the tablet has dissolved, refrain from eating or drinking anything for the next 10 minutes. 

To achieve optimal results, take Saphris exactly as directed at around the same time(s) daily. Avoid increasing the dosage or taking it more frequently than prescribed, as it will not expedite improvement and may heighten the risk of side effects. 

Keep taking this medication even if you feel better. Discontinuation of intake should only be done after consulting your doctor. 

Side Effects 

Listed below are the potential adverse effects of Saphris. Tell your doctor promptly if any of them persists or worsens. 

Common Side Effects 

• Dizziness, drowsiness, or tiredness 
• Restlessness or agitation 
• Numbness or tingling around the mouth 
• Muscle stiffness or jerky movements 
• Nausea or altered taste perception 
• Increased appetite or weight gain 

Serious Side Effects 

• Uncontrolled muscle movements in the face, such as: 
  • Chewing 
  • Lip smacking 
  • Frowning 
  • Tongue movement 
  • Blinking 
  • Eye movement 
• Ulcers, blisters, swelling, or peeling in the mouth 
• Light-headed feeling, like you might pass out 
• Breast pain or swelling, along with nipple discharge 
• Low white blood cell counts, which may manifest as: 
  • Fever 
  • Chills 
  • Mouth sores 
  • Skin sores 
  • Sore throat 
  • Cough 
  • Difficulty breathing 
• Severe nervous system reaction, characterized by: 
  • Very stiff (rigid) muscles 
  • High fever 
  • Sweating 
  • Confusion 
  • Fast or irregular heartbeats 
  • Tremors 
  • Sensation of potential fainting 

Call your doctor right away if you encounter any of the serious side effects listed above. 

Allergic Reactions 

Although rare, a severe allergic reaction to Saphris may occur. Seek immediate medical attention if you encounter any signs of an allergic response, such as: 

• Hives 
• Rapid heartbeats 
• Dizziness 
• Wheezing 
• Difficulty breathing 
• Swelling of the face, lips, tongue, or throat 

Not all side effects of Saphris are included in this list. Notify your doctor if any unlisted effects occur. 

Cautions 

Before starting treatment with Saphris, inform your doctor if you have any known allergies, particularly to asenapine or other medications. 

Consult your pharmacist for additional information about Saphris, as it may contain inactive ingredients that may cause allergic reactions or other complications. 

To ensure Saphris is safe for you, disclose to your physician your medical background, especially if you have a history of: 

• Liver problems 
• Heart problems (e.g., past heart attack, angina, abnormal heart rhythm) 
• Stroke 
• Diabetes (including family history) 
• Obesity 
• Low blood pressure 
• Seizures 
• Low white blood cell count 
• Dehydration 
• Breast cancer 
• Substance use disorder (e.g., overuse of or addiction to drugs/alcohol) 
• Alzheimer’s disease 
• Dementia 
• Trouble swallowing 
• Breathing trouble during sleep (sleep apnea) 

Notify all your healthcare providers of any current or recently started or stopped medications, including prescription and over-the-counter drugs, vitamins, and herbal supplements, to lower the risk of drug interaction with Saphris. 

Saphris can inhibit the elimination of certain medications from the body, including paroxetine and others, thereby influencing their efficacy. 

Check the labels of all your medicines (e.g., allergy or cough-and-cold products) for drowsiness-causing ingredients and consult your pharmacist for safe use. Inform them if you are also taking other drowsiness-inducing products, including: 

• Opioid pain or cough relievers (e.g., codeine, hydrocodone) 
• Alcohol 
• Marijuana (cannabis) 
• Sleep or anxiety medications (e.g., alprazolam, lorazepam, zolpidem) 
• Muscle relaxants (e.g., carisoprodol, cyclobenzaprine) 
• Antihistamines (e.g., cetirizine, diphenhydramine) 

Saphris can cause drowsiness. Refrain from driving or operating machinery until you know its effects on you. 

Saphris may also induce dizziness, lightheadedness, and fainting when rising rapidly from a lying position, especially when initiating the medication. To mitigate this issue, take precautionary measures by getting out of bed gradually and resting your feet on the floor for a few minutes before standing up. 

Older adults may exhibit heightened sensitivity to Saphris side effects, particularly drowsiness, dizziness, lightheadedness, and QT prolongation. These effects can increase the risk of falling. 

The use of Saphris may impair the body’s ability to regulate temperature in extreme heat. During treatment, limit physical exertion, remain indoors whenever feasible, wear lightweight clothing in hot conditions, avoid sun exposure, and maintain proper hydration. 

Prolonged or high doses of Saphris may lead to an irreversible movement disorder, which is more likely to develop with extended usage, particularly in women or older adults. 

Notify your doctor of your pregnancy status, particularly if you are in the final trimester or intend to conceive. In case of pregnancy while on Saphris, contact your doctor, for this medication may pose risks to newborns if taken during the late stages of pregnancy. 

The transfer of asenapine into breast milk is uncertain. Seek advice from your doctor prior to breastfeeding.