A description of Caplyta long term effects is largely missing on the package insert. Short term effects are reported in more detail.
Caplyta is sometimes called a “novel” or 3rd generation antipsychotic with the generic name of lumapeterone. Although its original approval 2019 was for treating schizophrenia, in 2021 the FDA granted additional approval for treating depression in bipolar conditions. Below we’ll look at why it’s considered a novel medication.
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There is not much in the public record specifically about long-term effects of Caplyta, since it has only been available since 2019. Drug regulators rely most heavily on historical data from studies on other antipsychotic medications.1-5
In comparing other antipsychotic medications, Caplyta is hoped to be less likely to induce movement disorders and less likely to cause weight gain.6 Weight gain and movement disorders are the 2 most cited reasons why people discontinue antipsychotic medications. Adverse reactions below are taken from the drug’s label and other sources where indicated.
Some Caplyta Long-term Effects may include:
Stroke, cerebrovascular adverse effects
Neuroleptic Malignant Syndrome
Tardive Dyskinesia
Dystonia
Dysphagia (difficulty swallowing)
Metabolic dysregulation
Immune system dysregulation
Blood pressure problems
Seizure
Impaired cognitive function
Somnolence, fatigue, potential for increased frequency of falls
Headache
Dry mouth
Body temperature dysregulation
Nausea, vomiting
Decreased appetite
Changes to liver enzymes
Dizziness
Diarrhea
Abdominal pain
Increased frequency of upper respiratory tract infection
Blurred vision
Increased prolactin levels
Some of the above adverse effects may improve over time, and some may worsen, and persist until the drug is withdrawn. Rarely, such as tardive dyskinesia, some may persist even after an antipsychotic drug is discontinued. Anecdotal reports can be found in various online sources, that are not on the above list. If you have experienced concerning side effects from Caplyta, you may want to let the FDA know by accessing the medication adverse events portal where these can be made known for the benefit of others.
Why is Caplyta called a Novel Antipsychotic?
ALL antipsychotic medication labels including Caplyta clearly state that their pharmacological mechanisms of action are not known. Theories of how they work are proposed, but are still unknown. Antipsychotics from the 1950s forward to the present have been suggested to either suppress or activate certain neurotransmitters, or to partially do so, along with perhaps affecting other neurotransmission factors. These mechanics are as yet not completely understood.
These early antipsychotic drugs were found useful in reducing unwanted symptoms of schizophrenia such as hallucinations, hearing voices, or agitation. For this reason, antipsychotics were originally licensed to use in the treatment of schizophrenia. In a crisis, antipsychotics do work to reduce schizophrenic symptoms. But their long-term effects are also incompletely understood.
And also of some concern, as more drugs come to market, the range of conditions this class of drugs is licensed to treat has expanded.
In 2019 Caplyta was approved to treat symptoms of schizophrenia in adults, followed by approval for treating depression in bipolar 1 and bipolar 2 conditions in 2021.
Although the pharmaceutical mechanisms of action are still uncertain, it has been surmised that Caplyta affects dopamine, serotonin, and glutamate transmission. This is not unlike many of the earlier antipsychotics that have come on the market since the 1950s. For patent purposes, each drug must claim a distinct molecular profile, even though they are all reportedly based on manipulating neurotransmission as a feature that is common to them all.
Certainly, the prescribing applications are new, and point to why the term novel can be correctly used to describe Caplyta.4,5
Is Long-Term Caplyta Safe in Pregnancy?
The drug’s label reports safety concerns for the child where the drug is taken during pregnancy, especially up to and including the 3rd trimester. Additionally, it has been determined that the drug does leech into the breast milk of nursing mothers — therefore breastfeeding while taking Caplyta is not recommended.1
Where the mother has taken Caplyta during pregnancy, the newborn may experience a number of withdrawal and extrapyramidal symptoms. These adverse effects may lessen in a few days after birth, or may persist much longer, requiring long-term care or in some cases, hospitalization.
Neonatal risks to the newborn can include:
Agitation
Hypertonia (muscle stiffness, difficult to move the muscles)
Hypotonia (floppiness, weak muscles)
Tremor
Somnolence
Respiratory distress
Feeding disorder
Feeding disorder is a termed used in pediatrics to denote problems in feeding such as these:
Arching or stiffening of the back during feeding
Sucking weakly
Drooling
Gagging
Spitting out, or spitting up after swallowing
Coughing
Not gaining weight as expected
The disorder itself can be misdiagnosed as a symptom of “autism” or a number of other potential diagnoses, especially by those who are over-eager to implement labeling and drugging with experimental medications at every turn, especially in children and other vulnerable populations.8,9
For new mothers, dealing with such problems can be overwhelming for both mother and child. These neonatal long-term effects may be best avoided by gently weaning the mother off Caplyta well before the third trimester.
Caplyta and Concerns about Infertility
Though no human studies were reported, animal studies on Caplyta showed that the drug can impair both female and male fertility. Regulators require prescribers to disclose these concerns to their patients before prescribing Caplyta, especially for those of child-bearing age, or who are planning a pregnancy.
Caplyta and the Elderly Population
As in all antipsychotic medications, Caplyta packaging has to contain a “black box” warning for elderly dementia patients. This is because past studies showed that elderly dementia patients compared to younger patients, experienced a significantly increased risk for death when taking antipsychotic medications.
Apart from the dementia psychosis population, no age-specific drug trials were done to determine if Caplyta had other risks specific to elderly patients compared to younger patients. However, in the Drug Safety Journal an expert opinion on the antipsychotic class of drugs generally was expressed that stated dose-dependent risks were present in the elderly who used antipsychotic medications. These included increased risk for falls and fractures, extrapyramidal effects, pneumonia, pulmonary embolism, venous thromboembolism and infections require extra vigilant monitoring to prevent such outcomes in this population. Safety concerns based on real-world data regarding risks for diabetes and kidney injury were also voiced.7
Alternatives at ATMC to Help Caplyta Long-Term Effects
It is not at all uncommon for persons who have taken antipsychotic medication for a long time, to experience unwanted side effects, and who decide to reduce or discontinue the medication.10,11
The difficulty can be in finding the correct help to do so safely. This is our specialty at Alternative to Meds Center. In a safe and friendly in-patient setting, we have helped thousands of people improve their mental wellness while at the same time reduce or eliminate medications that either stopped working, or in some cases just did not work well at all.
Each person is unique, and so their program must also be uniquely tailored to that person’s specific profile, history, and what they want to achieve and improve.
There cannot be a one-size-fits-all approach. What works best is thorough assessments, lab testing, nutrition and diet corrections, slow, slow, slow tapering managed by physicians who are familiar with tapering off antipsychotics, flanked by a wealth of comfort therapies for stress reduction, exercise for feel-good energy, cleansing for neurotransmitter rehabilitation, individual counseling, and many other well-managed holistic therapeutics used at ATMC.
Call us for more information for you or a loved one, and find out how easy it may be to enroll and start reclaiming your mental wellness. ATMC is insurance friendly and we can help determine what coverage you can expect. It is possible to recover from the long-term effects of Caplyta and other medications by learning about and using the correct tools. Find out more by calling us today.
Originally Published October 22, 2025 by Diane Ridaeus
This content has been reviewed and approved by a licensed physician.
Dr. Samuel Lee
Dr. Samuel Lee is a board-certified psychiatrist, specializing in a spiritually-based mental health discipline and integrative approaches. He graduated with an MD at Loma Linda University School of Medicine and did a residency in psychiatry at Cedars-Sinai Medical Center and University of Washington School of Medicine in Seattle. He has also been an inpatient adult psychiatrist at Kaweah Delta Mental Health Hospital and the primary attending geriatric psychiatrist at the Auerbach Inpatient Psychiatric Jewish Home Hospital. In addition, he served as the general adult outpatient psychiatrist at Kaiser Permanente. He is board-certified in psychiatry and neurology and has a B.A. Magna Cum Laude in Religion from Pacific Union College. His specialty is in natural healing techniques that promote the body’s innate ability to heal itself.
Diane is an avid supporter and researcher of natural mental health strategies. Diane received her medical writing and science communication certification through Stanford University and has published over 3 million words on the topics of holistic health, addiction, recovery, and alternative medicine. She has proudly worked with the Alternative to Meds Center since its inception and is grateful for the opportunity to help the founding members develop this world-class center that has helped so many thousands regain natural mental health.
Medical Disclaimer: Nothing on this Website is intended to be taken as medical advice. The information provided on the website is intended to encourage, not replace, direct patient-health professional relationships. Always consult with your doctor before altering your medications. Adding nutritional supplements may alter the effect of medication. Any medication changes should be done only after proper evaluation and under medical supervision.
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These early antipsychotic drugs were found useful in reducing unwanted symptoms of schizophrenia such as hallucinations, hearing voices, or agitation. For this reason, antipsychotics were originally licensed to use in the treatment of schizophrenia. In a crisis, antipsychotics do work to reduce schizophrenic symptoms. But their long-term effects are also incompletely understood.
