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Bipolar & Mood Disorders

Mood Stabilizers Demystified: Lithium, Lamictal, and Beyond

Navigate the complexities of Bipolar Disorder treatment with this essential guide, “Mood Stabilizers Demystified.” Drawing on the latest VA/DoD and NICE 2025 guidelines, this article provides evidence-based clarity on first-line treatments like Lithium and Lamotrigine Lamictal…

Originally published November 13, 2025

Last reviewed May 27, 2026

Clinical review: Fady Boules, PMHNP-BC

Mood stabilizers are the backbone of long-term care for bipolar disorder, schizoaffective disorder, and several other conditions where the brain’s mood-regulating systems lose their footing. They are some of the most studied medications in psychiatry. They are also some of the most misunderstood — wrapped in old stories about toxicity, weight gain, and the idea that they are somehow second-class compared to newer treatments.

This essay walks through what mood stabilizers actually are, what each of the major options does well, what the trade-offs are, and what has changed in the last few years. The goal is not to choose a medication for you — that decision belongs to you and your prescriber — but to give you the same map your clinician is working from, in plain language.

What “mood stabilizer” actually means

The term is older than the medications it now describes. Lithium was first used for mania in 1949, decades before the modern category of “mood stabilizer” existed. Today the label is used loosely for any medication that does one or more of four things in bipolar illness:

  1. Treats acute mania.
  2. Treats acute bipolar depression.
  3. Prevents the next manic episode.
  4. Prevents the next depressive episode.

A true broad-spectrum mood stabilizer does all four. Most medications in the category are stronger at some of these than at others — which is why a single bipolar diagnosis can require two or even three medications working together. Treating the depressive side of bipolar illness, in particular, requires different tools than treating mania, and a medication that quiets a manic episode may do nothing for the long depressions that often follow.

There is no test that tells your prescriber which medication to choose. The choice is shaped by which pole of the illness is more dominant for you, what other conditions you live with, what side effects you can tolerate, what has worked or failed before in your family, whether you are pregnant or planning pregnancy, and what your insurance covers. Shared decision-making is not a slogan in this category — it is how the medication actually gets chosen.

Lithium — old, unfashionable, still the strongest evidence base

Lithium is a naturally occurring mineral salt. It is also the most studied mood stabilizer in psychiatry. More than seventy years of research has produced something most newer medications cannot match: large-scale, long-term evidence that lithium reduces the risk of suicide in people with bipolar disorder.1 That is not a small finding. Bipolar disorder carries one of the highest suicide rates of any psychiatric illness, and lithium is the only mood stabilizer with this specific anti-suicidal signal across multiple high-quality reviews.

Lithium also works well for classic euphoric mania, for long-term prevention of new manic episodes, and — though less reliably — for the depressive side of the illness. It is one of the four first-line monotherapy options for bipolar I depression in the 2023 Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) guideline update.2

What lithium asks of you

Lithium is taken by mouth, usually once or twice a day. Your prescriber will check a blood level periodically because lithium has a narrow margin between the dose that helps and the dose that causes side effects. This is not a reason to avoid lithium — it is a reason to take the lab work seriously.

The medication can affect the thyroid gland and the kidneys over time, so your prescriber will order baseline labs before you start, follow up frequently in the first year, and then settle into a regular monitoring schedule once you are stable. People over sixty-five, people who take ibuprofen or naproxen regularly, people on common blood pressure medications such as ACE inhibitors or diuretics, and people whose kidney function is declining all need closer monitoring.

Side effects in the first few weeks often include mild tremor, increased thirst and urination, some weight gain, and occasional digestive complaints. Many of these settle. Long-term users sometimes develop hypothyroidism, which is straightforward to treat with thyroid replacement and does not usually mean stopping lithium.

The toxicity rules that matter

Lithium toxicity is not a mystery — it has predictable triggers, and most cases are preventable.

The biggest one is dehydration. Lithium is filtered out of the body by the kidneys, and when you become dehydrated — whether from a stomach bug, a heatwave, hard exercise, or the kind of summer afternoon the Inland Empire is known for — the kidneys hold onto lithium harder, and the level in your blood rises. Vomiting and diarrhea are especially dangerous. So is the casual use of common anti-inflammatory pain relievers (ibuprofen, naproxen), which can push lithium levels up by reducing kidney clearance.

There is also a newer concern: starting a GLP-1 medication such as semaglutide (Ozempic, Wegovy) or tirzepatide (Mounjaro, Zepbound) while on lithium has caused several documented cases of lithium toxicity, mostly during the first few weeks of GLP-1 dose increases.3 The mechanism is the GI side effects — the nausea, vomiting, and reduced fluid intake — pulling lithium up the way any other dehydration event would. If you are on lithium and starting a GLP-1, your prescriber should plan more frequent lithium level checks during titration. This is one of the topics covered in more detail in the essay on antidepressant and mood-stabilizer drug interactions.

Lithium in pregnancy — what’s actually true

For decades, women with bipolar disorder were told that lithium causes a four-hundred-fold increase in the risk of a rare heart defect called Ebstein’s anomaly. That number came from a registry of lithium-exposed babies built in the 1970s, with no controls and no way to account for confounding factors. It is now known to be a gross overestimate.

The largest and best-designed study to look at this question — Patorno and colleagues, published in the New England Journal of Medicine in 2017 — found a risk that is real but dose-dependent and much smaller than the old number.4 At lower daily doses, the study found no statistically significant increase in the risk of cardiac malformations. At moderate daily doses, the increase was modest and not statistically significant. At higher daily doses, the risk was approximately three times that of unexposed pregnancies — still much lower than the old “four-hundred-fold” figure but high enough to warrant careful planning. The right dose for any individual pregnancy is a decision for you and a clinician familiar with both bipolar disorder and perinatal psychiatry, not a number to take from an essay.

The 2023 American College of Obstetricians and Gynecologists (ACOG) Clinical Practice Guideline reflects this updated evidence.5 Lithium is now considered acceptable in pregnancy for bipolar I disorder when the alternative is destabilization of mood, with the additional steps of fetal echocardiography around 18–20 weeks and close monitoring of lithium levels through pregnancy and the postpartum period. Lithium clearance changes dramatically during pregnancy — levels often drop in the second and third trimesters as the body’s fluid volume expands, then rebound sharply after delivery, which is when toxicity risk is highest.

The decision is individual. But it is no longer a binary “stop lithium because pregnancy.” It is a shared decision made with a clinician familiar with both bipolar disorder and perinatal psychiatry.

Important context. A 2024 review of lithium pregnancy data was published by authors with a direct financial relationship to a commercial lithium manufacturer. The Patorno 2017 study remains the methodologically strongest evidence and is the basis for current clinical guidelines.

Lamotrigine — the depression-side specialist

Lamotrigine (Lamictal) does something lithium does less reliably: it protects against the depressive side of bipolar illness. It is approved by the FDA for the maintenance treatment of bipolar I disorder — meaning prevention of new episodes after acute treatment — and the evidence is strongest for preventing depressive recurrences specifically.6 It is not an antimanic medication. It is not the first medication to reach for in an acute episode of any kind. It is a long-game medication, used for people whose bipolar illness has more depression than mania, or for whom lithium alone has not held the depressive side stable.

The slow titration is not optional

Lamotrigine carries a rare but serious risk: a severe skin reaction called Stevens-Johnson syndrome (SJS) or, in its most dangerous form, toxic epidermal necrolysis. The risk is highest in the first few weeks of treatment, and it is dramatically reduced by titrating the dose up slowly — over weeks — rather than starting at the target dose. This is why lamotrigine prescriptions come with a starter pack and a calendar, and why a single missed handful of doses can mean restarting the whole titration. If you stop lamotrigine for more than a few days, you cannot restart at your old dose. You restart at the beginning.

Any new rash in the first eight weeks of lamotrigine — especially with fever, mouth sores, swollen lymph nodes, or eye involvement — is a reason to stop the medication and seek medical attention the same day. After the first few months, the SJS risk drops sharply.

The hormonal contraception interaction every reproductive-age patient should know

Estrogen-containing oral contraceptives — the combined birth control pill, the patch, and the vaginal ring — lower lamotrigine blood levels by roughly half. The mechanism is induction of glucuronidation, the liver enzyme system that breaks lamotrigine down.7 In practice, this means a woman stabilized on lamotrigine for bipolar disorder who starts a combined birth control pill may experience a return of depressive symptoms, sometimes within weeks, because her lamotrigine level has quietly fallen.

The interaction also runs the other direction. During the pill-free week of cyclic oral contraceptives, lamotrigine levels rebound — sometimes nearly doubling — which can cause dizziness, double vision, or unsteadiness.

This is a Class I drug interaction that the FDA has listed in the lamotrigine label for years. It does not affect progesterone-only methods: the hormonal IUD, the implant (Nexplanon), the progesterone-only pill, and the contraceptive injection (Depo-Provera) do not change lamotrigine levels. For women on lamotrigine for bipolar disorder, progesterone-only contraception is generally the simpler and safer choice.

If you are on lamotrigine and starting any form of hormonal contraception, tell your psychiatric prescriber before you start it, not after. Dose adjustments may be needed. If you are switching off a combined pill, the same is true in reverse — your lamotrigine dose will likely need to come down.

Valproate — effective for mania, with reproductive restrictions that have tightened

Valproate (Depakote, divalproex) is one of the most effective antimanic medications available, especially for mixed episodes and rapid-cycling forms of bipolar disorder. It is also a medication with reproductive safety concerns severe enough that prescribing standards have changed substantially in the last several years.

What valproate does well

For an acute manic or mixed episode, valproate works quickly — often within a week. It is used both as monotherapy and in combination with antipsychotics. It can also be used for long-term prevention, although lithium has the stronger long-term evidence in that role. Valproate is taken by mouth, comes in immediate-release, delayed-release, and extended-release forms, and requires baseline and periodic monitoring of liver enzymes, blood counts, and drug levels.

Common side effects include weight gain, sedation, tremor, hair thinning, and digestive upset. Less common but more serious effects include pancreatitis, liver injury (rare in adults but historically devastating in young children on multiple anticonvulsants), and low platelet counts.

Reproductive risk is the headline story

Valproate carries one of the strongest reproductive warnings in psychiatry. The FDA placed a black box warning on the medication for major congenital malformations — about 11 percent of valproate-exposed pregnancies, compared with a background rate of two to three percent in the general population. Neural tube defects, including spina bifida, occur in about one to two percent of exposed pregnancies. Beyond the structural malformations, valproate exposure in pregnancy carries a substantial risk of neurodevelopmental disorders in the child, including autism (adjusted hazard ratio approximately 3.1) and lower IQ scores compared to siblings not exposed in utero. This pattern is named in the literature as Fetal Valproate Syndrome.8

The regulatory response has tightened over time. In November 2023, the UK’s MHRA issued new restrictions that valproate must not be initiated in any patient under fifty-five — regardless of sex — unless two specialists independently document that no alternative is acceptable.9 The MHRA followed up in September 2024 with precautionary guidance that valproate use by men around the time of conception may increase neurodevelopmental risk in offspring. The data behind the male-conception advisory are preliminary and incompletely characterized, but the precautionary framing has been adopted by regulators internationally.

In US practice, valproate remains available without the formal regulatory restrictions seen in the UK, but the clinical standard is the same: a documented benefit-risk discussion, effective contraception (preferably user-independent, such as an IUD or implant), and a written plan if pregnancy is a future possibility. For women of reproductive age, lamotrigine, lithium, or a second-generation antipsychotic is almost always the better mood-stabilizer choice.

Carbamazepine and oxcarbazepine — useful, but interaction-heavy

Carbamazepine (Tegretol, Equetro) is FDA-approved for acute mania and is used in bipolar disorder, particularly for patients who have not responded to lithium or valproate. Oxcarbazepine (Trileptal) is a structurally related medication used off-label for mood stabilization.

Both medications are usable but come with two persistent issues. The first is the breadth of their drug interactions: carbamazepine is one of the most potent inducers of the liver enzyme CYP3A4 in clinical psychiatry. It lowers the blood levels of many medications, including most oral contraceptives (a critical pregnancy-prevention failure point), several antipsychotics, many anticoagulants such as apixaban and warfarin, and even other anticonvulsants — including lamotrigine, whose levels drop by roughly forty percent in the presence of carbamazepine. Carbamazepine also induces its own metabolism, which means that the dose that produces a therapeutic level at week one may be subtherapeutic by week four as the liver ramps up.

The second issue is the rare risk of severe skin reactions and a rare but dangerous drop in white blood cell counts (agranulocytosis). These risks are why carbamazepine prescriptions include periodic complete blood counts. Carbamazepine can also cause low sodium levels in the blood, which can present as confusion, weakness, or fatigue and which is more common in older adults.

For people of Asian ancestry, carbamazepine carries an additional consideration: a genetic variant called HLA-B*1502, more common in populations of Han Chinese, Thai, and several other Southeast and South Asian backgrounds, sharply increases the risk of severe skin reactions. Testing for this variant before starting carbamazepine is the standard of care for patients in these groups.

Second-generation antipsychotics in bipolar disorder

The category of “mood stabilizers” has quietly expanded to include several second-generation antipsychotics, which are now used for acute mania, acute bipolar depression, and maintenance prevention. Some of these are first-line; others are second-line. None of them are perfect.

Quetiapine (Seroquel) has FDA approvals across both poles of bipolar illness — mania, depression, and maintenance. It is one of the four first-line monotherapy options for bipolar I depression in the 2023 CANMAT update. Quetiapine causes sedation (sometimes useful, sometimes limiting), weight gain, and metabolic effects on cholesterol and blood sugar. The metabolic load is the main trade-off and the main reason patients switch off it.

Lurasidone (Latuda) is FDA-approved for bipolar I depression as both monotherapy and as add-on therapy with lithium or valproate. It is one of the four first-line CANMAT options. Compared with quetiapine, lurasidone is much more metabolically neutral — minimal weight gain, little effect on glucose or lipids — which makes it attractive for patients already carrying metabolic risk. The catch is that lurasidone must be taken with a meal of at least 350 calories to be absorbed adequately; without food, its blood levels can fall to about a third of what they would be with food.

Lumateperone (Caplyta) was approved by the FDA in December 2021 for depressive episodes in bipolar I and bipolar II disorder, both as monotherapy and as an add-on to lithium or valproate.10 In November 2025, it gained an additional FDA approval as add-on treatment for major depressive disorder, becoming one of the few antipsychotics with approvals spanning schizophrenia, bipolar depression, and unipolar depression. CANMAT 2023 places it as second-line for bipolar I and bipolar II depression — strong evidence, but with less long-term clinical experience than the first-line options. Its main differentiator is the metabolic profile: trial data show essentially no weight gain, no meaningful changes in cholesterol or blood sugar, and a low rate of extrapyramidal side effects. It is taken once daily, requires no titration, and can be taken with or without food. For patients who have struggled with weight gain on quetiapine or olanzapine, lumateperone is one of the most clinically meaningful options to discuss.

Olanzapine-fluoxetine combination (Symbyax) is FDA-approved for bipolar depression. It is highly effective but among the worst medications for weight gain and metabolic side effects in this class, and it is usually reserved for patients who have not responded to better-tolerated options.

Cariprazine (Vraylar) is FDA-approved for both bipolar mania and bipolar I depression. Compared with quetiapine and olanzapine, cariprazine is more metabolically neutral, but it has a higher rate of akathisia — the inner restlessness that can drive patients off antipsychotics entirely. Patients on cariprazine should be asked specifically about akathisia at every visit, because it is often described as something other than a medication side effect (“I just can’t sit still anymore”) and dismissed.

Aripiprazole (Abilify) is FDA-approved for bipolar mania, both as monotherapy and as add-on therapy. It is more metabolically neutral than quetiapine or olanzapine and is one of several options for acute mania.

And beyond — what’s actually new

For thirty years, every medication marketed for schizophrenia and the psychotic dimensions of bipolar disorder worked, broadly, by blocking dopamine D2 receptors. Older antipsychotics and newer ones differed in how cleanly they did it and what else they touched, but the dopamine block was the engine. In September 2024, that changed.

Cobenfy (xanomeline-trospium) received FDA approval on September 26, 2024, for the treatment of schizophrenia in adults — the first antipsychotic in over thirty years to work through a mechanism that does not block dopamine D2 receptors at all.11 The medication combines xanomeline, which acts on muscarinic acetylcholine receptors in the brain (specifically the M1 and M4 subtypes), with trospium, a peripherally restricted muscarinic blocker that prevents the unwanted body-wide cholinergic effects xanomeline would otherwise cause. In the pivotal EMERGENT-2 and EMERGENT-3 phase 3 trials, Cobenfy reduced symptoms of schizophrenia by clinically meaningful amounts compared with placebo, with very low rates of the movement side effects, weight gain, and sedation that have made traditional antipsychotics hard to live with.

Cobenfy is not currently FDA-approved for bipolar disorder. Whether the muscarinic mechanism will eventually find a place in bipolar treatment is being studied. The reason to mention it in a mood-stabilizer essay is the mechanism itself: the field has been waiting decades for a non-dopaminergic option, and its arrival is the most significant pharmacological development in psychiatry in a generation. If you have schizoaffective disorder or a bipolar illness with prominent psychotic features, Cobenfy may come up in a conversation with your prescriber. It must not be combined with other anticholinergic medications, and it must be taken on an empty stomach. It does not yet have an indication for mood disorders.

How the choices actually get made

The 2023 CANMAT and ISBD update — the most widely used international guideline for bipolar disorder pharmacotherapy — places four medications as first-line monotherapy for bipolar I depression: quetiapine, lithium, lamotrigine, and lurasidone. For acute mania, the first-line monotherapy options are lithium, quetiapine, valproate, and aripiprazole, with several other antipsychotics available. For long-term maintenance, lithium, quetiapine, and lamotrigine carry the strongest evidence, with lamotrigine biased toward depressive prevention and lithium biased toward both manic prevention and the suicide-risk reduction discussed earlier.

The right starting place depends on you. A patient with classic euphoric mania and a family history of lithium response is on a very different path than a patient with bipolar II disorder, a long history of depressions, and reproductive-age contraception needs. A patient with significant metabolic risk should not be started on olanzapine when lurasidone or lumateperone is on the table. A patient who drinks alcohol heavily should not be on valproate. A patient who works in a job with random drug screens should be told that several mood stabilizers can produce false-positive results on certain immunoassays.

A medication that is “right” on a guideline can still be the wrong medication for a particular life. This is the part of psychiatry that does not yet have an algorithm.

Common myths, briefly

“Mood stabilizers turn you into a zombie.” Some do cause sedation, especially in the first weeks. Most do not. Sedation is a side effect, not a feature of the category — and if it persists, it is a reason to change medications, not a reason to stop treatment altogether.

“Lithium is old, so it must be inferior.” Lithium remains the medication with the strongest evidence for suicide-risk reduction in bipolar disorder. It is also one of four first-line monotherapy options for bipolar I depression in the most current international guideline. Old does not mean weak.

“All mood stabilizers are unsafe in pregnancy.” This is not accurate. Valproate carries the strongest warnings — FDA black box, MHRA restrictions, well-documented developmental risks. Lithium carries a real but dose-dependent risk that is much smaller than once believed. Lamotrigine has relatively favorable reproductive safety data. Treatment in pregnancy is a benefit-risk conversation, not a default discontinuation.

“If I feel fine, I can stop.” The maintenance medications work by keeping you in a state you might describe as “fine.” Stopping is the most common reason for relapse in bipolar disorder. If you want to come off a medication, do it with your prescriber, not on your own — and not all at once.

“Mood stabilizers are addictive.” They are not. Lithium, lamotrigine, valproate, and the antipsychotics used as mood stabilizers do not produce craving, tolerance, or withdrawal in the addictive sense. Some of them — particularly lamotrigine — have to be tapered slowly, but the reason is rebound mood symptoms, not physiological dependence.

What to expect from monitoring

For lithium: baseline labs before starting, including kidney function, thyroid, calcium, and a pregnancy test where applicable. Lithium levels checked frequently in the first few months and then on a regular maintenance schedule once stable. Monitoring increases with age, with the start of any medication that affects kidney clearance, during illness, and during pregnancy.

For valproate: baseline and periodic liver enzymes, complete blood counts, and drug levels. Pregnancy testing where applicable.

For lamotrigine: no routine blood monitoring. The clinical monitoring is for rash in the first weeks and for the hormonal contraception interaction described above.

For carbamazepine: baseline and periodic complete blood counts, liver enzymes, sodium, and drug levels. HLA-B*1502 testing in patients of relevant ancestry before starting.

For second-generation antipsychotics used as mood stabilizers: baseline and periodic weight, waist circumference, blood pressure, fasting glucose or hemoglobin A1c, and lipid panel. Some require additional monitoring depending on the agent.

This sounds like a lot. In practice, most of these labs run together on a single panel a few times a year once you are stable.

When to call your prescriber sooner rather than later

Any new rash in the first weeks of lamotrigine or carbamazepine. Any persistent vomiting, diarrhea, or signs of dehydration while on lithium. Confusion, severe tremor, or unsteady gait on lithium — these can be signs of toxicity. Sudden mood changes — either a new depressive episode or signs of mania such as decreased need for sleep, racing thoughts, or unusually elevated mood. Suicidal thoughts. Pregnancy, planned pregnancy, or a missed period if pregnancy was not planned. Starting any new prescription medication, over-the-counter medication, or supplement — particularly GLP-1 medications, common pain relievers, or hormonal contraception.

These are not reasons to stop the medication on your own. They are reasons to make a call.


If you or someone you know is in crisis

Call or text 988 — Suicide & Crisis Lifeline, available 24/7 En español: 988 y oprima 2 Veterans: 988 y oprima 1 — or text 838255 LGBTQ+ youth: The Trevor Project — call 1-866-488-7386 or text START to 678-678 Crisis Text Line: Text HOME to 741741

San Bernardino County residents: SBC DBH ACCESS Line: 888-743-1478 (24/7) SBC Mobile Crisis / CCRT: 800-398-0018

For life-threatening emergencies, call 911 or go to your nearest emergency room. Arrowhead Regional Medical Center (ARMC) has a dedicated adolescent psychiatric ER (ages 13–17).


Clinical review: Fady Boules, PMHNP-BC


Footnotes

  1. Cipriani A, Hawton K, Stockton S, Geddes JR. Lithium in the prevention of suicide in mood disorders: updated systematic review and meta-analysis. BMJ. 2013;346:f3646. doi:10.1136/bmj.f3646. https://pubmed.ncbi.nlm.nih.gov/23814104/

  2. Keramatian K, Chithra NK, Yatham LN. The CANMAT and ISBD Guidelines for the Treatment of Bipolar Disorder: Summary and a 2023 Update of Evidence. Focus (Am Psychiatr Publ). 2023;21(4):344–353. doi:10.1176/appi.focus.20230009. https://pmc.ncbi.nlm.nih.gov/articles/PMC11058959/

  3. Al-Soleiti M, Leung JG, Mubaydeen T, et al. Lithium toxicity following semaglutide initiation: case series. Mayo Clinic Proceedings. 2025. https://pubmed.ncbi.nlm.nih.gov/40999647/

  4. Patorno E, Huybrechts KF, Bateman BT, et al. Lithium use in pregnancy and the risk of cardiac malformations. N Engl J Med. 2017;376(23):2245–2254. doi:10.1056/NEJMoa1612222. https://pubmed.ncbi.nlm.nih.gov/28591541/

  5. American College of Obstetricians and Gynecologists. Clinical Practice Guideline #5: Treatment and Management of Mental Health Conditions During Pregnancy and Postpartum. June 2023. https://www.acog.org/clinical/clinical-guidance/clinical-practice-guideline/articles/2023/06/treatment-and-management-of-mental-health-conditions-during-pregnancy-and-postpartum

  6. Lamictal (lamotrigine) Prescribing Information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf

  7. Center for Women’s Mental Health, Massachusetts General Hospital. Oral Contraceptives Reduce Lamotrigine (Lamictal) Blood Levels. https://womensmentalhealth.org/posts/contraceptives-lamictal-blood-levels/

  8. American Epilepsy Society. Position Statement on the Use of Valproate by Women of Childbearing Potential. 2021. https://aesnet.org/about/about-aes/position-statements/position-statement-on-the-use-of-valproate-by-women-of-childbearing-potential

  9. MHRA. National Patient Safety Alert: Valproate — organisations to prepare for new regulatory measures. November 2023. https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-valproate-organisations-to-prepare-for-new-regulatory-measures-for-oversight-of-prescribing-to-new-patients-and-existing-female-patients-natpsa-slash-2023-slash-013-slash-mhra

  10. U.S. Food and Drug Administration. Caplyta (lumateperone) Approval Package NDA 209500, Supplement 005. December 17, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/209500Orig1s005_Redacted.pdf

  11. U.S. Food and Drug Administration. FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia [press release]. September 26, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-drug-new-mechanism-action-treatment-schizophrenia