Alternative to Meds Editorial Team
Medically Reviewed by Dr John Motl MD
Table of Contents:
- Video: Facts You Need to Know About Antipsychotic Meds
- Caplyta Long-Term Effects – What is Known?
- Why is Caplyta Called a Novel Antipsychotic?
- Is Long-Term Caplyta Safe in Pregnancy?
- Caplyta and Fertility Concerns
- Caplyta and the Elderly Population
- Alternatives at ATMC to Help Caplyta Long-Term Effects
- Video: ATMC’s Founder, Lyle Murphy, Answers Viewers’ Tough Questions
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.
Caplyta Long-Term Effects — What is Known?
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Some of the above adverse effects may improve over time, and some may worsen, and persist until the drug is withdrawn.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
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.
You may also enjoy reading these articles:
for Help with the Long-Term Effects of Taking Caplyta
Sources:
1. FDA drug label Caplyta (lumateperone oral capsules) approval 2019 [cited 2025 Oct 22]
2. Durgam S, Kozauer SG, Earley WR, Chen C, Huo J, Lakkis H, Stahl S, McIntyre RS. Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features: A Randomized Placebo-Controlled Trial. J Clin Psychopharmacol. 2025 Mar-Apr 01;45(2):67-75. doi: 10.1097/JCP.0000000000001964. Epub 2025 Feb 14. PMID: 39946099; PMCID: PMC11882193. [cited 2025 Oct 22]
3. Maini K, Hollier JW, Gould H, Bollich V, John LaForge J, Cornett EM, Edinoff AN, Kaye AM, Kaye AD. Lumateperone tosylate, A Selective and Concurrent Modulator of Serotonin, Dopamine, and Glutamate, in the Treatment of Schizophrenia. Health Psychol Res. 2021 Jun 19;9(1):24932. doi: 10.52965/001c.24932. PMID: 34746489; PMCID: PMC8567771. [cited 2025 Oct 22]
4. Abou-Setta AM, Mousavi SS, Spooner C, et al. First-Generation Versus Second-Generation Antipsychotics in Adults: Comparative Effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Aug. (Comparative Effectiveness Reviews, No. 63.) Introduction. [cited 2025 Oct 22]
5. Maini K, Hollier JW, Gould H, Bollich V, John LaForge J, Cornett EM, Edinoff AN, Kaye AM, Kaye AD. Lumateperone tosylate, A Selective and Concurrent Modulator of Serotonin, Dopamine, and Glutamate, in the Treatment of Schizophrenia. Health Psychol Res. 2021 Jun 19;9(1):24932. doi: 10.52965/001c.24932. PMID: 34746489; PMCID: PMC8567771. [cited 2025 Oct 22]
6. Tarzian M, Ndrio M, Chique B, et al. (September 28, 2023) Illuminating Hope for Mental Health: A Drug Review on Lumateperone. Cureus 15(9): e46143. doi:10.7759/cureus.46143 [cited 2025 Oct 22]
7. Khalid J, Aparasu RR. Adverse effects associated with antipsychotic use in older adults. Expert Opin Drug Saf. 2024 Sep;23(9):1157-1171. doi: 10.1080/14740338.2024.2386377. Epub 2024 Aug 12. PMID: 39076106. [cited 2025 Oct 22]
8. Pergeline H, Gonnet L, Fernandez A, Solla F, Poinso F, Guivarch J. Diagnosis and Treatment of Pediatric Feeding Disorders: A Narrative Literature Review. Children (Basel). 2025 Mar 6;12(3):333. doi: 10.3390/children12030333. PMID: 40150615; PMCID: PMC11941252. [cited 2025 Oct 22]
9. Peverill S, Smith IM, Duku E, Szatmari P, Mirenda P, Vaillancourt T, Volden J, Zwaigenbaum L, Bennett T, Elsabbagh M, Georgiades S, Ungar WJ. Developmental Trajectories of Feeding Problems in Children with Autism Spectrum Disorder. J Pediatr Psychol. 2019 Sep 1;44(8):988-998. doi: 10.1093/jpepsy/jsz033. PMID: 31089730; PMCID: PMC6705712. [cited 2025 Oct 22]
10. Horowitz MA, Moncrieff J. Gradually tapering off antipsychotics: lessons for practice from case studies and neurobiological principles. Curr Opin Psychiatry. 2024 Jul 1;37(4):320-330. doi: 10.1097/YCO.0000000000000940. Epub 2024 May 9. PMID: 38726815; PMCID: PMC11139239. [cited 2025 Oct 22]
11. Leucht S, Schneider-Thoma J, Burschinski A, Peter N, Wang D, Dong S, Huhn M, Nikolakopoulou A, Salanti G, Davis JM. Long-term efficacy of antipsychotic drugs in initially acutely ill adults with schizophrenia: systematic review and network meta-analysis. World Psychiatry. 2023 Jun;22(2):315-324. doi: 10.1002/wps.21089. PMID: 37159349; PMCID: PMC10168166. [cited 2025 Oct 22]
Originally Published October 22, 2025 by Diane Ridaeus
Dr. John Motl, M.D.
Dr. Motl is currently certified by the American Board of Psychiatry and Neurology in Psychiatry, and Board eligible in Neurology and licensed in the state of Arizona. He holds a Bachelor of Science degree with a major in biology and minors in chemistry and philosophy. He graduated from Creighton University School of Medicine with a Doctor of Medicine. Dr. Motl has studied Medical Acupuncture at the Colorado School of Traditional Chinese Medicine and at U.C.L.A.
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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.