Auvelity

Auvelity is a combination antidepressant medicine used to treat major depressive disorder (MDD) in adults and agitation associated with dementia due to Alzheimer's disease (AD). Auvelity contains dextromethorphan, an NMDA receptor antagonist, and bupropion, a norepinephrine-dopamine reuptake inhibitor (NDRI).

• Auvelity should not be used as an “as-needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease.

Auvelity works by targeting multiple brain pathways involved in depression and agitation. Dextromethorphan works by blocking NMDA receptors, increasing the levels of glutamate, a chemical messenger (neurotransmitter), to improve mood and brain connectivity. While bupropion helps dextromethorphan last longer in the body and increases dopamine and norepinephrine levels to improve depression and agitation symptoms.

Auvelity's usual dose for MDD is 1 tablet (45 mg/105 mg) taken once daily for 3 days, followed by 1 tablet twice daily, separated by at least 8 hours. Tablets should be swallowed whole and not crushed or chewed.

Auvelity's usual dose for agitation associated with dementia due to AD is 1 tablet (30 mg/105 mg) taken once daily for 7 days, followed by 1 tablet twice daily, separated by at least 8 hours. On Day 15, the dose is increased to the maximum dose of Auvelity 45 mg/105 mg) twice daily, separated by at least 8 hours, based on tolerability. Tablets should be swallowed whole and not crushed or chewed.

Auvelity is a rapid-acting antidepressant that started working as early as 1 week, and patients' depression symptoms continued to improve over time when compared to placebo in a 6-week clinical study for MDD (Study 1, NCT04019704).

Auvelity became an FDA-approved medicine on August 18, 2022, for adults with major depressive disorder (MDD). Approval was extended on April 30, 2026, to include agitation associated with dementia due to Alzheimer's disease.

Auvelity’s active ingredient, dextromethorphan, works as a N-methyl D-aspartate (NMDA) receptor antagonist and is also an agonist at the sigma-1 receptors. This helps to improve symptoms of depression and agitation by increasing glutamate levels, changing glutamate signalling, and regulating other neurotransmitters.

The second active ingredient, bupropion, helps dextromethorphan work more effectively by slowing how quickly it’s broken down in the body. It does this by blocking an enzyme called CYP2D6, allowing dextromethorphan to stay active longer. As a norepinephrine-dopamine reuptake inhibitor, bupropion also helps improve mood by increasing levels of dopamine and norepinephrine in the brain.

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about the cost of Auvelity.

You may also be eligible for an Auvelity savings card or an Auvelity coupon. Ask your doctor or pharmacist if you qualify.

• Take Auvelity exactly as your healthcare provider tells you to take it.
• Your healthcare provider may increase your dose of Auvelity during treatment. Follow the directions provided by your healthcare provider. Do not change your dose of Auvelity without first talking to your healthcare provider.
• If you take Auvelity 1 time a day, take your tablet in the morning.
• If your healthcare provider increases your dose to 2 times a day, take the Auvelity tablets at least 8 hours apart.
• Do not take more than 2 Auvelity tablets in 24 hours.
• Swallow tablets whole. Do not crush, chew, or divide the tablets.
• Tablets may be taken with or without food.
• Do not take more than 2 tablets in 24 hours.
• Your blood pressure will need to be checked often.
• Do not stop using this medicine suddenly. Ask your doctor before stopping the medicine.
• This medicine may cause false results on a drug-screening urine test. Tell the laboratory staff that you take this medicine, and they can do a more specific drug screening test that should not have this problem.

Auvelity has a boxed warning for suicidal thoughts and behaviors. A boxed warning is the strongest safety-related warning issued by the FDA.

Increased risk of suicidal thoughts and actions.Auvelity and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. This medicine is not for use in children.

• Depression or other mental illnesses are the most important causes of suicidal thoughts or actions.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or the dose changes.
• Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions.
• Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider or get emergency help right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• new or worse depression
• feeling very agitated or restless
• trouble sleeping (insomnia)
• attempts to commit suicide
• new or worse anxiety
• panic attacks
• new or worse irritability
• acting aggressive, being angry, or violent
• an extreme increase in activity and talking (mania)
• acting on dangerous impulses
• other unusual changes in behavior or mood.

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Do not take Auvelity if you:

• have or had a seizure disorder
• have or had an eating disorder such as anorexia nervosa or bulimia
• have recently suddenly stopped drinking alcohol or use medicines called benzodiazepines, barbiturates, or antiseizure medicines, and you have recently suddenly stopped taking them.
• take a monoamine oxidase inhibitor (MAOI) medicine
• have stopped taking an MAOI in the last 14 days
• are being treated with the antibiotic linezolid or intravenous methylene blue
• are allergic to dextromethorphan, bupropion, or any of the other ingredients. See the end of this page for a complete list of ingredients.

Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue.

Do not start this medicine if you stopped taking an MAOI in the last 14 days.

Do not start taking an MAOI for at least 14 days after you stop treatment with Auvelity.

You should not use Auvelity if you are allergic to it, or if you have:

• a seizure disorder;
• an eating disorder such as anorexia or bulimia; or
• if you have suddenly stopped using alcohol, seizure medication, or a sedative (such as Xanax, Valium, Fiorinal, Klonopin, and others).

Do not use Auvelity if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take bupropion and dextromethorphan.

Tell your doctor if you have ever had:

• low blood sodium;
• a stroke;
• a head injury, seizures, or brain or spinal cord tumor;
• glaucoma;
• heart disease, high blood pressure, or a heart attack;
• diabetes or low blood sugar;
• kidney or liver disease;
• depression, bipolar disorder, or other mental illness, or a family history of bipolar disorder, depression, or suicide;
• problems walking or a history of falls; or
• if you have alcoholism or drug addiction.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. Auvelity may harm your unborn baby if you take it during pregnancy. Auvelity is not recommended during pregnancy.If you become pregnant or think you are pregnant during treatment, tell your healthcare provider right away. Your healthcare provider will prescribe another treatment for females who plan to become pregnant.There is a pregnancy registry for females who are exposed to this medicine during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Auvelity and their baby. If you become pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/clinical-and-research programs/pregnancyregistry/antidepressants/.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. One of the active ingredients called bupropion, passes into your breast milk. Do not breastfeed during treatment with this medicine and for 5 days after the final dose.

Common Auvelity side effects

The most common Auvelity side effects in MDD include:

• dizziness
• diarrhea
• dry mouth
• excessive sweating
• headache
• feeling sleepy
• sexual function problems.

The most common Auvelity side effects in agitation that may happen with dementia due to Alzheimer's disease include:

• dizziness
• stomach upset or pain.

Serious Auvelity side effects

Also, see Warnings.

Auvelity may cause serious side effects, including:

Seizures. There is a risk of seizures during treatment with this medicine. The risk is higher in people who:

• take higher doses of this medicine
• have certain medical problems
• take it with certain other medicines or alcohol

Do not take Auvelity with other medicines unless your healthcare provider tells you to.If you have a seizure during treatment, stop taking this medicine and call your healthcare provider right away. Do not take this medicine again if you have a seizure.

Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment. Your healthcare provider should check your blood pressure before you start taking and during treatment.

Manic episodes. Manic episodes may happen in people with bipolar disorder who take Auvelity. Symptoms may include:

• greatly increased energy
• racing thoughts
• unusually grand ideas
• talking more or faster than usual
• severe trouble sleeping
• reckless behavior
• excessive happiness or irritability

Unusual thoughts or behaviors. One of the ingredients in Auvelity (bupropion), can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.

Eye problems (angle-closure glaucoma). Auvelity may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.

Dizziness. this medicine may cause dizziness, increasing your fall risk.

Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take Auvelity with certain other medicines. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:

• agitation
• seeing or hearing things that are not there (hallucinations)
• confusion
• coma
• fast heartbeat
• changes in blood pressure
• dizziness
• sweating
• flushing
• high body temperature (hyperthermia)
• shaking (tremors), stiff muscles, or muscle twitching
• loss of coordination
• seizures
• nausea, vomiting, diarrhea.

Low levels of salt (sodium) in your blood. This drug can cause low sodium levels in the blood. Symptoms include headache, trouble concentrating, memory changes, confusion, weakness, and unsteadiness. Severe or sudden cases may cause hallucinations, fainting, seizures, or coma. Untreated severe low sodium can be fatal. Older adults and people who take diuretics or become dehydrated are at higher risk. Tell your healthcare provider if you notice any of these symptoms.

Allergic reactions. This medicine may cause allergic reactions that can happen right away or later during treatment. Tell your healthcare provider right away if you develop a skin rash, swelling, itching, shortness of breath, hives, muscle or joint pain, chest pain, or fever.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Auvelity for MDD

Dose: One tablet once daily in the morning for three days, then increase to the maximum recommended dosage of one tablet twice daily, separated by at least 8 hours.

Dose modifications:

• Moderate renal impairment: One tablet by mouth once daily in the morning.
• CYP2D6 poor metabolizers: One tablet by mouth once daily in the morning.

Comment:

Before initiating treatment with this medicine, assess blood pressure; screen patients for a history of bipolar disorder, mania, or hypomania; and determine if patients are receiving any other medications that contain bupropion or dextromethorphan.

Dosage form and strength: Extended-release tablet containing dextromethorphan hydrobromide 45 mg and bupropion hydrochloride 105 mg.

Usual Adult Dose for Auvelity for Agitation Associated With Dementia Due to Alzheimer's Disease

Dose: One tablet (Auvelity 30 mg/105 mg) once daily in the morning for 7 days, then increase to 1 tablet (Auvelity 30 mg/105 mg) twice daily, separated by at least 8 hours.

On Day 15, increase the dose to the maximum dose of Auvelity 45 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability.

Dose modifications:

• Maximum dose in moderate renal impairment: One tablet Auvelity 45 mg/105 mg by mouth once daily in the morning.
• Maximum dose in CYP2D6 poor metabolizers: One tablet Auvelity 45 mg/105 mg by mouth once daily in the morning.

Comment:

Before initiating treatment with this medicine, assess blood pressure; screen patients for a history of bipolar disorder, mania, or hypomania; and determine if patients are receiving any other medications that contain bupropion or dextromethorphan.

If you miss a dose, do not take an extra dose to make up for the dose you missed. Wait and take your next dose at the regular time. Do not take more than 1 dose of this medicine at a time.

In case of overdose, call the poison control helpline at 1-800-222-1222. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• vomiting
• drowsiness
• unresponsiveness
• changes in vision
• seizures
• hallucinating (seeing things or hearing voices that do not exist)
• coma (loss of consciousness for a period of time)
• rapid or pounding heartbeat
• loss of coordination

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Auvelity and some other medicines may affect each other causing possible serious side effects. Auvelity may affect the way other medicines work and other medicines may affect the way Auvelity works.

Especially tell your healthcare provider if you take:

• other medicines containing bupropion or dextromethorphan
• medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and MAOIs
• tricyclic antidepressants (TCAs)
• medicines used to treat migraine headaches called triptans
• theophylline
• corticosteroids
• oral diabetes medicines or use insulin to control your blood sugar
• medicines to control appetite (anorectic)
• nicotine medicines to help you stop smoking
• street (illicit) drugs
• benzodiazepines, sedatives-hypnotics (sleep medicines), or opiates
• CNS stimulants
• digoxin
• levodopa
• amantadine.

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Auvelity with your other medicines.

Do not start or stop any other medicines during treatment without talking to your healthcare provider first. Stopping treatment suddenly may cause you to have serious side effects.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

• Limit or avoid using alcohol during treatment. If you usually drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.
• Do not drive a car or use heavy machinery until you know how this medicine affects you. Auvelity can affect your ability to do these things safely.

• Store at room temperature between 68°F and 77°F (20°C and 25°C).
• Store in the original container.
• Keep this medicine and all medicines out of the reach of children.

Active ingredients: dextromethorphan hydrobromide, bupropion hydrochloride.Inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets also contain red iron oxide and yellow iron oxide.

Distributed and Marketed by: Axsome Therapeutics, Inc., New York, NY 10007