Auvelity is a prescription oral medicine approved for the treatment of major depressive disorder (MDD) in adults. It is a combination tablet containing dextromethorphan and bupropion. While many factors can influence weight, it is important to understand the relationship between Auvelity and potential weight changes. It is not known if AUVELITY is safe and effective for use in children. AUVELITY is not approved for uses other than the treatment of MDD. The ingredients in AUVELITY, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses.
Understanding Auvelity
How Auvelity Works
While the exact mechanism of action is not fully understood, Auvelity works differently from traditional antidepressants. AUVELITY is made up of 2 parts. Each part is thought to work on different receptors in the brain, which affect certain brain chemicals. The 2 parts of AUVELITY are:
- Dextromethorphan: Dextromethorphan affects glutamate-your brain’s most abundant neurotransmitter. The problem is, when dextromethorphan is on its own, your body usually breaks it down too fast.
- Bupropion: Bupropion helps levels of dextromethorphan stay higher for longer than if dextromethorphan was given by itself. Bupropion affects brain chemicals called dopamine and norepinephrine.
AUVELITY is an extended-release medication designed to slowly release the right amount of medication over the course of the day. The specific combination of dextromethorphan and bupropion was FDA-approved after extensive clinical trials of more than 1000 adults with MDD.
Auvelity vs. Wellbutrin
Both Auvelity and Wellbutrin (bupropion) are effective for depression. A small randomized controlled trial (RCT) reported that Auvelity worked significantly better than Wellbutrin and took less time to start working.
In the trial, 43 people prescribed Auvelity experienced an overall decrease in their Montgomery-Åsberg Depression Rating Scale (MADRS) score of 13.7 points after 6 weeks, compared to a decrease of 8.8 points in the 37 people prescribed bupropion (least-squares mean difference=-4.9; 95% CI=-3.1, -6.8). It also had a faster onset of effect, with improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) score being observed as early as week 1 and differences being statistically significant by week 2.
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Weight Gain and Auvelity: What the Data Says
Weight gain is a common concern for individuals starting antidepressant medications. However, it's important to consider the available evidence and understand the specific profile of each drug.
Clinical Trial Results
Weight gain has not been reported with Auvelity. In fact, in one 6-week study, participants taking Auvelity lost, on average, half a pound, while those taking a placebo gained about one pound. This suggests that Auvelity is less likely to be associated with weight gain compared to some other antidepressants.
Indirect Effects
Although weight loss is not a direct side effect of Auvelity, the drug can cause a decreased appetite. This could lead to weight loss in some people. Although Auvelity does not directly cause weight gain, it can cause certain side effects that could indirectly lead to weight gain, including insomnia and fatigue. For example, not getting enough sleep can contribute to weight gain. This is because sleep affects your levels of the hormones leptin and ghrelin, which control feelings of hunger and fullness. Not sleeping enough can throw these hormones off balance and lead to overeating. Also, if you have insomnia or fatigue from Auvelity, you may feel too tired to exercise. In some people, this could lead to weight gain.
Other Antidepressants and Weight Changes
It is useful to consider how Auvelity compares to other antidepressants regarding weight changes.
Weight Gain Differences Among Antidepressants
An observational study, "Medication-Induced Weight Change Across Common Antidepressant Treatments," published in the Annals of Internal Medicine, examined weight changes associated with eight common first-line antidepressants. Utilizing electronic health record data from 183,118 patients, the study compared weight changes over a 24-month period. The results indicated that, compared to sertraline, escitalopram, paroxetine, duloxetine, venlafaxine, and citalopram were associated with higher weight gain, while bupropion was associated with less weight gain. Fluoxetine showed similar weight changes to sertraline.
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Important Caveats
- Bupropion (Wellbutrin): Often associated with weight loss, but it is usually not helpful for anxiety.
- Mirtazapine (Remeron): Known as the antidepressant with the highest increase in appetite and weight gain, but it was not included in the study.
- Desvenlafaxine (Pristiq): A newer SNRI thought to have less weight gain than venlafaxine, duloxetine, and SSRIs, but it was not examined in this study.
- Other Newer Antidepressants: Medications such as Auvelity, Viibryd, Trintellix, and others were also not studied.
Common Side Effects of Auvelity
While weight gain may not be a primary concern with Auvelity, it's important to be aware of other potential side effects. The most common side effects of AUVELITY include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating.
Serious Side Effects
AUVELITY may cause serious side effects. Ask your HCP how to recognize the serious side effects below and what to do if you think you have one:
- Seizures: There is a risk of seizures during treatment with AUVELITY. The risk is higher if you take higher doses of AUVELITY, have certain medical problems, or take AUVELITY with certain other medicines. Do not take AUVELITY with other medicines unless your healthcare provider tells you to. If you have a seizure during treatment with AUVELITY, stop taking AUVELITY and call your HCP right away. Do not take AUVELITY again if you have a seizure.
- Increases in blood pressure (hypertension): Some people may get high blood pressure during treatment with AUVELITY. Your HCP should check your blood pressure before you start taking and during treatment with AUVELITY.
- 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 HCP.
- 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 HCP if you have eye pain, changes in your vision, or swelling or redness in or around the eye.
- Dizziness: AUVELITY may cause dizziness which may increase your risk for falls.
- Serotonin syndrome: A potentially life-threatening problem called serotonin syndrome can happen when you take AUVELITY with certain other medicines. Call your HCP or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms: agitation, hallucinations, confusion, coma, fast heartbeat, blood pressure changes, dizziness, sweating flushing, high body temperature (hyperthermia), shaking (tremors), stiff muscles, or muscle twitching, loss of coordination, seizures, nausea, vomiting, diarrhea
Boxed Warning: Increased Risk of Suicidal Thoughts and Behaviors
AUVELITY (aw-VEHL-ah-tee) 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. AUVELITY is not for use in children.
You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine.
Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you: suicidal thoughts or actions, new or worsening depression or anxiety, agitation or restlessness, trouble sleeping (insomnia), acting aggressive, being angry, or violent, an extreme increase in activity and talking (mania), panic attacks, new or worsening irritability, acting on dangerous impulses, other unusual changes in behavior or mood.
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Important Considerations Before Taking Auvelity
Before starting AUVELITY, tell your healthcare provider about any medications you're currently taking, including any that contain bupropion or dextromethorphan. Also, be sure to give your healthcare provider a detailed medical history, including a personal or family history of bipolar disorder, mania, or hypomania. Your healthcare provider should take your blood pressure both before and during treatment with AUVELITY.
Contraindications
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).
- 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 ingredients in AUVELITY.
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. Don't start AUVELITY if you stopped taking an MAOI in the last 14 days.
Specific Medical Conditions
Tell your HCP about all your medical conditions, including if you:
- Have problems with your liver or kidneys.
- Have diabetes, heart disease, or high blood pressure.
- Have a history of seizure, stroke, eating disorder, head injury, or have a tumor in your brain or spinal cord.
- Have a history of alcohol or drug abuse.
- Have a history of seizure, eating disorder, or abuse alcohol or drugs.
- Have low blood sugar, low blood sodium levels, or a history of falls.
- You take certain other medicines that could interact with AUVELITY.
- Have or had a condition known as bipolar disorder, a family history of bipolar disorder, suicide, or depression.
- Have high pressure in the eye (glaucoma).
Review the list below with your HCP. AUVELITY may not be right for you if:
- You drink a lot of alcohol.
- You abuse prescription or street drugs.
- You are pregnant or plan to become pregnant.
- You are breastfeeding or plan to breastfeed.
How to Take Auvelity
Take AUVELITY exactly as instructed by your HCP. Typically, when you start AUVELITY, you take it once a day for the first 3 days. After that, you take it twice a day, with at least 8 hours in between.
You can take AUVELITY with or without food. Swallow the tablets whole and don't chew, cut, or crush the tablets. Do not take more than 2 pills within 24 hours.
If you miss a dose, don’t take an extra one to make up for it. Just take your next dose at the regular time and always follow your healthcare provider's dosing instructions. Do not take more than 2 pills within 24 hours.
When taking AUVELITY, limit or avoid using alcohol. And 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.
Don't drive a car or use heavy machinery until you know how AUVELITY affects you. AUVELITY can affect your ability to do these things safely.
The Importance of Personalized Treatment
Side effects are unique to each patient. One unique and important aspect of antidepressant side effects is their variability from patient to patient. While some individuals may experience weight gain on a particular medication, others might lose weight on the same drug. This variability underscores the importance of personalized treatment plans. It's crucial to note that this data should not push a patient to change their antidepressant medication if it is performing well with only mild weight gain. In most cases, there is no significant weight gain with most antidepressants.