FDA Approves Auvelity for Agitation in Alzheimer’s Disease - Scorecard - MDSpire

FDA Approves Auvelity for Agitation in Alzheimer’s Disease

The oral combination therapy expands treatment options for agitation associated with dementia due to Alzheimer’s disease.

  • By

  • Kathryn Wighton

  • April 30, 2026

  • 3 min

Share

Clinical Scorecard: FDA Approves Auvelity for Agitation in Alzheimer’s Disease

At a Glance

CategoryDetail
ConditionAgitation associated with dementia due to Alzheimer’s disease
Key MechanismsDextromethorphan acts on N-methyl-D-aspartate and sigma-1 receptors; bupropion inhibits CYP2D6.
Target PopulationPatients with Alzheimer’s disease experiencing agitation.
Care SettingOutpatient and inpatient settings for dementia care.

Key Highlights

  • Agitation affects up to 76% of Alzheimer’s patients.
  • Auvelity showed significant improvement in agitation symptoms in clinical trials.
  • Long-term treatment reduces relapse of agitation symptoms.
  • Dosing regimen differs from major depressive disorder.
  • Boxed warning for suicidal thoughts and behaviors.

Guideline-Based Recommendations

Diagnosis

  • Assess agitation symptoms in patients with Alzheimer’s disease.

Management

  • Initiate treatment with 30 mg/105 mg once daily, increase to twice daily after 7 days.

Monitoring & Follow-up

  • Monitor for adverse reactions such as dizziness and dyspepsia.

Risks

  • Monitor for seizures, increased blood pressure, and risk of serotonin syndrome.

Patient & Prescribing Data

Adults with Alzheimer’s disease experiencing agitation.

Concomitant use of monoamine oxidase inhibitors is contraindicated.

Clinical Best Practices

  • Consult full prescribing information for drug interactions and contraindications.
  • Do not use as an as-needed treatment for agitation.

Related Resources & Content

Original Source(s)

FDA Approves Auvelity for Agitation in Alzheimer’s Disease

  • by Kathryn Wighton

  • April 30, 2026

Related Content

Esketamine for negative emotions and cognitive function in general anesthesia: a systematic review and meta-analysis

FDA Approves Low-Dose Macrocyclic Contrast Agent for MRI

The macrocyclic gadolinium-based contrast agent has a recommended dose of 0.01 mmol/kg actual body weight.

Consensus Guidance May Improve Sinonasal Mass Outcomes

Multidisciplinary recommendations emphasize biopsy technique, imaging, and pathology review in patients with suspected sinonasal malignancy.