Dextromethorphan hydrobromide / bupropion hydrochloride (Auvelity) is a combination of bupropion and dextromethorphan that was first indicated in August of 2022 for adults with major depressive disorder (MDD). In April, Auvelity received FDA approval for the treatment of agitation associated with dementia due to Alzheimer's disease. Read on to learn more about Auvelity, including its warnings and precautions, contraindications, and more.
Medication Overview:
- Brand Name: Auvelity
- Generic Name: dextromethorphan hydrobromide / bupropion hydochloride
- Treatment for: Major depressive disorder, agitation associated with dementia due to Alzheimer’s disease
- Company: Axsome
- Initial FDA Approval: August 2022
| Indicated Condition | Indication | Age | Date Approved |
|---|---|---|---|
| Major Depressive Disorder | Indicated for the treatment of major depressive disorder (MDD) in adults. | Adults | August 2022 |
| Agitation Associated with Dementia Due to Alzheimer's Disease | Indicated for the treatment of agitation associatied with dementia due to Alzheimer's disease. | Adults | April 2026 |
Warnings and Precautions:
- Seizure: Risk is dose-related. Discontinue if seizure occurs.
- Increased Blood Pressure and Hypertension: Auvelity can increase blood pressure and cause hypertension. Assess blood pressure before initiating treatment and monitor periodically during treatment.
- Activation of Mania or Hypomania: Screen patients for bipolar disorder.
- Psychosis and Other Neuropsychiatric Reactions: Instruct patients to contact a healthcare provider if such reactions occur.
- Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
- Dizziness: Auvelity may cause dizziness. Take precautions to reduce falls and use caution when operating machinery.
- Serotonin Syndrome: Use of Auvelity with selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants increases the risk. Discontinue if occurs.
- Embryo-fetal Toxicity: May cause fetal harm. Advise pregnant females of the potential risk to a fetus. Discontinue treatment in pregnant females and use alternative treatment for females who are planning to become pregnant.
- Hyponatremia: Can occur in association with SIADH.
Dosage and Administration:
Prior to initiating treatment with Auvelity: assess blood pressure; screen patients for history of bipolar disorder, mania, or hypomania; and determine if patients are receiving any other medications that contain bupropion or dextromethorphan.
For MDD, the starting dosage is Auvelity 45 mg/105 mg once daily in the morning. On day 4, increase to the maximum recommended dosage of Auvelity 45 mg/105 mg twice daily, separated by at least 8 hours. Do not exceed two doses within the same day.
For agitation associated with dementia due to Alzheimer’s disease, the starting dosage is Auvelity 30 mg/105 mg once daily in the morning. On day 8, increase to Auvelity 30 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability. On day 15, increase to the maximum recommended dosage of Auvelity 45 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability. Do not exceed two doses within the same day.
Swallow tablets whole, do not crush, divide, or chew.
Moderate renal impairment: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, the maximum recommended dosage is one tablet of 45 mg/105 mg by mouth once daily in the morning.
CYP2D6 poor metabolizers: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, the maximum recommended dosage is one tablet of 45 mg/105 mg by mouth once daily in the morning.
Contraindications:
- Seizure disorder.
- Cirrent or prior diagnosis of bulimia or anorexia nervosa.
- Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.
- Use with an MAOI or within 14 days of stopping treatment with Auvelity. Do not use Auvelity within 14 days of discontinuing an MAOI.
- Known hypersensitivity to bupropion, dextromethorphan, or other components of Auvelity.
Drug Interactions:
- Strong CYP2D6 inhibitors: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, maximum recommended dosage is one tabled of 45 mg dextromethorphan hydrobromide/105 mg bupropion hydrochloride by mouth once daily in the morning.
- Strong CYP2B6 inducers: Avoid use.
- CYP2D6 Substrates: Increases the exposures of drugs that are substrates of CYP2D6.
- Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels.
- Drugs that lower seizure threshold: Coadministration my increase risk of seizure.
- Dopaminergic drugs: Central Nervous System (CNS) toxicity can occur with concomitant use.
- Drug-laboratory test interactions: Auvelity can cause false-positive urine test results for amphetamines.
Adverse Reactions:
- MDD: Most common adverse reactions (≥5% and more than twice as frequently as placebo): dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis.
- Agitation associated with dementia due to Alzheimer’s disease: Most common adverse reactions (≥5% and more than twice as frequently as placebo): dizziness and dyspepsia.
Please note: This article is current as of July 20, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
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