Caplyta, known by its generic name lumateperone, is an atypical antipsychotic medication approved to treat schizophrenia and depressive episodes associated with bipolar I or II disorder in adults. Like all medications, it can cause a range of side effects, from mild and temporary discomfort to more serious complications. The potential for side effects requires a thorough discussion with a healthcare provider before and during treatment to ensure safe and effective use.
Common side effects of Caplyta
Many patients experience mild and manageable side effects, particularly when first starting the medication. Some of these effects may subside over time as the body adjusts to the treatment.
- Somnolence or sedation: One of the most frequently reported side effects, especially in patients with schizophrenia, is sleepiness or drowsiness. Taking Caplyta at night may help reduce daytime grogginess.
- Dry mouth: Also known as xerostomia, dry mouth is a common symptom for both schizophrenia and bipolar depression patients.
- Nausea and vomiting: These gastrointestinal effects are reported by some patients taking Caplyta.
- Dizziness: This can occur, sometimes leading to lightheadedness or feeling unsteady. It is advisable to stand up slowly from a sitting or lying position to prevent orthostatic hypotension.
- Headache: This is a notable side effect, particularly in patients being treated for bipolar depression.
- Fatigue: Some patients report feeling unusually tired or having low energy.
- Weight gain: While less common and generally milder than with some other antipsychotics, weight gain can still occur.
Serious and notable side effects
While less frequent, more serious adverse reactions can occur and require immediate medical attention if suspected.
Metabolic changes
Antipsychotic drugs are known to cause metabolic issues. While Caplyta is considered to have a lower metabolic risk profile compared to some older medications, it can still cause:
- High blood sugar and diabetes: In some cases, blood sugar levels can become dangerously high. Symptoms include increased thirst and hunger, frequent urination, and confusion.
- High cholesterol and triglycerides: Regular monitoring of fasting lipid profiles is recommended.
- Weight gain: Though studies have shown lower rates compared to placebo in some cases, monitoring weight is still advised.
Neuroleptic malignant syndrome (NMS)
NMS is a rare but potentially fatal condition associated with antipsychotic drugs. Symptoms include high fever, muscle stiffness, confusion, and changes in heart rate, breathing, and blood pressure.
Tardive dyskinesia (TD)
TD is a syndrome of potentially irreversible, involuntary movements, particularly affecting the face, tongue, and body. The risk increases with the duration of treatment and is higher in older adults.
Orthostatic hypotension and falls
Caplyta can cause a sudden drop in blood pressure when changing position, which can lead to dizziness, lightheadedness, fainting, and an increased risk of falls and injuries. This risk is highest at the beginning of treatment.
Blood cell problems
Rare but serious blood problems, including leukopenia (low white blood cell count) and neutropenia, have been reported. Your healthcare provider may monitor your complete blood count, especially in the first few months of therapy.
Boxed warnings from the FDA
Caplyta carries two specific boxed warnings, the most serious type of warning from the Food and Drug Administration (FDA).
- Elderly patients with dementia-related psychosis: There is an increased risk of death when antipsychotic drugs are used to treat elderly patients with psychosis related to dementia. Caplyta is not approved for this use.
- Suicidal thoughts and behaviors: Antidepressant medications, including Caplyta, may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. This risk is highest in the initial months of treatment or following dose adjustments. Caplyta is not approved for use in pediatric patients.
Comparison of common side effects across indications
While many side effects are similar for Caplyta when used for schizophrenia and bipolar depression, the incidence can vary slightly. The following table highlights some common side effects reported in short-term clinical trials.
| Side Effect | Schizophrenia (Caplyta 42 mg) | Bipolar Depression (Caplyta 42 mg) |
|---|---|---|
| Somnolence/Sedation | 24% | 13% |
| Nausea | 9% | 8% |
| Dry Mouth | 6% | 5% |
| Dizziness | 5% | 8% |
| Headache | Not commonly reported | 14% |
Managing Caplyta side effects
Your healthcare provider is the best source for managing side effects, but some general strategies can help.
- For sleepiness: If drowsiness is bothersome, discuss taking the medication in the evening with your doctor. Do not operate heavy machinery or drive until you know how Caplyta affects you.
- For orthostatic hypotension: Stand up slowly from sitting or lying down to reduce the risk of dizziness or fainting. Staying adequately hydrated can also help.
- For metabolic risks: Maintain a healthy diet and exercise routine. Your doctor will monitor your weight, blood sugar, and lipid levels regularly.
- For dry mouth: Sucking on sugar-free candies or chewing sugar-free gum can help.
- For temperature regulation: Avoid overheating and dehydration by drinking plenty of water, especially during exercise or in hot weather. Your body's ability to regulate its temperature can be disrupted by the medication.
Other considerations
It is important to remember that this article provides general information. Individual experiences with medication can vary, and serious side effects, while rare, do occur. Always discuss any concerns with your healthcare provider.
Conclusion
What side effects does Caplyta have? The answer includes a spectrum from common and manageable side effects like somnolence, nausea, and dry mouth to rare but serious risks such as NMS and tardive dyskinesia. The medication also carries important boxed warnings concerning elderly patients with dementia-related psychosis and the risk of suicidal thoughts and behaviors in young adults. While Caplyta is associated with a lower metabolic risk profile compared to some other antipsychotics, vigilant monitoring of weight, blood sugar, and lipids remains essential. Ultimately, understanding these potential side effects and working closely with your healthcare provider is key to safely and effectively managing your treatment with Caplyta.
Warning: This information is not a substitute for professional medical advice. Always consult with a healthcare provider regarding your specific medical condition and treatment plan.
For more detailed prescribing information, you can visit the FDA website: Access Data FDA Caplyta Label.
