Auvelity is a medicine for major depressive disorder approved by the FDA in 2022. It is an oral tablet that contains a combination of two medicines called dextromethorphan and bupropion.
How Does Auvelity Work for Major Depressive Disorder?
Auvelity helps to lessen the symptoms of major depressive disorder through a combination of two medicines that have antidepressant effects. Bupropion is an antidepressant that causes an increase in the chemicals dopamine and norepinephrine in the brain. Dextromethorphan, a cough suppressant that is found in many over-the-counter cough medicines, also changes mood-related chemicals in the brain. The combination of these two medicines treats depression symptoms better than bupropion alone.
How Was Auvelity Studied for Major Depressive Disorder?
Two clinical studies were conducted to see if Auvelity is safe and effective for adults with major depressive disorder. The scoring system used to measure the severity and improvement in depression symptoms was the Montgomery-Asberg Depression Rating Scale (MADRS). This is a 10-item questionnaire that assesses depression symptoms through questions about mood, guilt, sleep quality, and suicidal thoughts. The total score ranges from zero to 60, with higher scores indicating more severe depression symptoms. A larger decrease in MADRS score shows a bigger improvement in depression symptoms. The effectiveness of Auvelity was measured by MADRS scores at the beginning of the study and every week until week six of the study.
The studies included adults aged 18 to 65 with major depressive disorder who were experiencing a major depressive episode that was at least four weeks long with a MADRS score of at least 25. People with bipolar disorder, psychotic disorder, panic disorder, obsessive-compulsive disorder, substance use disorder within the last year, clinically significant risk of suicide, and history of seizure disorder were not included in the study. Also excluded from the study were people with treatment-resistant depression, meaning they did not get relief from depression symptoms after trying two or more other antidepressant medicines. The studies included people who were White, Black, Asian, and other races.
What Benefits Were Seen With Auvelity?
One study compared Auvelity to placebo, and the other compared Auvelity to bupropion, one of the two medicines in Auvelity. Both studies showed that people taking Auvelity had a larger decrease in MADRS scores compared to placebo and bupropion alone. This means Auvelity was shown to be more effective than placebo or bupropion alone at decreasing depression symptoms.
Auvelity (Bupropion and Dextromethorphan) | Placebo | |
By about how much did the MADRS score go down after 6 weeks? | 16 points | 12 points |
Auvelity (Bupropion and Dextromethorphan) | Bupropion Alone | |
By about how much did the MADRS score go down after 6 weeks? | 14 points | 9 points |
What Types of Medicine Interactions Can Happen?
Because Auvelity increases dopamine, use of other medicines that increase dopamine such as amantadine and levodopa can cause there to be too much dopamine in the brain. Symptoms of this include restlessness, agitation, tremor, trouble with balance or coordination, disruption of the normal ability to walk, feeling off-balance, and dizziness. If you are taking another medicine that increases dopamine, watch for these symptoms and let your health care provider know if you have any.
A dangerous increase in serotonin can happen when taking Auvelity with medicines that increase serotonin and can cause a condition known as serotonin syndrome. If this occurs, let your health care provider know and they may decide to stop Auvelity or the other medicine that is increasing serotonin.
Another kind of antidepressant called monoamine oxidase inhibitors (MAOIs) may also cause serotonin syndrome when taken with Auvelity. Allow 14 days between the use of Auvelity and any MAOI.
Auvelity can interact with and lower the blood levels of a heart medicine called digoxin. If you are taking digoxin and start taking Auvelity, your health care provider may ask you to get blood tests more often to monitor your digoxin levels.
The bupropion in Auvelity can increase the risk of brain-related and mental health-related events when taken with alcohol. Auvelity can also reduce alcohol tolerance. Avoid or limit alcohol use with Auvelity.
There are potential interactions between Auvelity and other medicines that are broken down similarly in the body. Many medicines are broken down by a system of liver enzymes called cytochrome P450 (CYP450) enzymes. When multiple medicines are taken together, the CYP450 enzymes can speed up or slow down the breakdown of those medicines. Let your healthcare provider know which prescription medicines, over-the-counter medicines, and supplements you are taking so that adjustments to Auvelity or your other medicines can be made.
Auvelity contains bupropion and dextromethorphan, both of which are active ingredients in medicines with other uses. Talk to your health care provider before starting any new medicines or supplements.
How Can I Get Auvelity?
To get Auvelity, you need a prescription from a health care provider. Primary care providers and mental health providers such as psychiatrists often prescribe this medicine. Retail and mail order pharmacies generally keep this medicine in stock. If you have insurance, check out the Auvelity savings card (www.auvelity.com/savings-card).
How Do I Take Auvelity?
Auvelity is an oral tablet. The recommended dosage is one tablet daily for the first three days, then one tablet twice daily, at least eight hours apart. Do not take more than two doses in the same day. Your health care provider will let you know your daily dosage and if a dosage increase is planned. Read the instructions for use, which you can get from your pharmacist. Auvelity stays in the body three to five days after stopping the medicine.
How Can I Tell If Auvelity Is Working?
You can tell if Auvelity is working because your major depressive disorder symptoms will improve. Your health care provider may measure this through the use of a questionnaire or scoring system such as a MADRS, AOQ, or PHQ-9. If your depression symptoms do not improve or do not improve enough, your health care provider may change your antidepressant medicines.
How Can I Prevent Side Effects or Tell If a Side Effect Is Happening?
Auvelity can cause an increase in blood pressure, especially when used with certain other medicines including a class of antidepressants called MAOIs. Your health care provider may recommend that you check your blood pressure regularly.
Auvelity can make you dizzy. Take extra care to prevent falls, especially if you have any trouble walking or with your balance. Do not drive or do other activities that require alertness or coordination until you know how Auvelity affects you.
Auvelity may cause changes to your eyes, which can trigger an episode of glaucoma. Let your health care provider know if you have any vision changes, eye pain or redness, or severe headaches or vomiting.
Changes in behavior have occurred in people taking bupropion. Let your health care provider know if you see or hear things that others do not see or hear (hallucinations), have difficulty recognizing what is real and what is not (psychosis), develop beliefs that are not rooted in reality (delusions), feel paranoid, have difficulty concentrating, or feel confused. If you have bipolar disorder, let your health care provider know if you are experiencing a low or high mood, also known as mania.
Auvelity or other antidepressants may increase the risk of suicidal thoughts or actions. If you or your child is about to harm themselves, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have new or increased thoughts of suicide or death, anxiety, depression, changes in your mood or behavior, or a suicide attempt.
Auvelity can cause seizures. Drinking alcohol or a fast decrease in regular alcohol use, as well as use with certain other medicines, can increase your risk of seizures. Stop and do not restart Auvelity if you have a seizure while taking Auvelity.
Auvelity can cause serotonin syndrome, which is when there is too much of a substance called serotonin (a mood-related brain chemical) in your body. This can happen when Auvelity is taken alone or with other medicines that affect serotonin. This condition can be life-threatening. Get emergency help if you have any symptoms of serotonin syndrome including sweating, fever, confusion, restlessness, seeing or hearing unusual things, dizziness, racing heartbeat, nausea, vomiting, diarrhea, seizures, muscle twitching, stiffness, or tremor. Let your health care provider know before starting any new medicines, including supplements. Do not stop any of your antidepressant medicines without discussing it with your health care provider first. Quickly stopping some antidepressants can also cause symptoms similar to serotonin syndrome.
Auvelity may not be safe in pregnancy and is not safe to use while breastfeeding. Let your health care provider know right away if you plan to become pregnant, are pregnant, or if you are breastfeeding. Do not breastfeed while taking Auvelity or within 5 days of your last Auvelity dose.
Auvelity may cause allergic reactions, which can be serious. Stop taking Auvelity and get help right away if you have any symptoms of a serious allergic reaction. Reports of side effects by persons are very important and are used to add information to the prescribing information. You don’t need to be certain that something you experienced was caused by Auvelity. If you experience anything that you think may be caused by Auvelity, you can report it by calling the FDA at 800-FDA-1088.
An Auvelity savings card from the manufacturer may allow you to pay as little as $0 for your Auvelity prescription. Whether you are eligible depends on the type of insurance plan you have and if your insurance covers Auvelity. You can find out more at www.auvelity.com/savings-card.
