How to Start Viloxazine ER in Adults With ADHD and Mood Symptoms
How should clinicians initiate viloxazine ER in adults with ADHD who also have prominent depression and/or anxiety symptoms?
Adults with ADHD commonly present with clinically significant depression and anxiety symptoms, and these comorbidities often complicate medication selection and sequencing. This study provides a real-world, flexible-dose treatment approach showing how viloxazine ER was started and followed in adults with ADHD plus prominent mood and/or anxiety symptoms, including patients already taking other psychiatric medications.
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Confirm that ADHD is the primary diagnosis
Use DSM-5-TR ADHD diagnostic criteria confirmed with the Mini-International Neuropsychiatric Interview for ADHD Studies. In the trial, treatment was limited to adults aged 18 years or older with a primary diagnosis of ADHD.
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Document baseline symptom burden across ADHD and mood or anxiety domains
Before starting treatment, establish that ADHD symptoms are clinically significant with an AISRS total score of 24 or higher and a CGI-S score of 3 or higher. Also confirm prominent comorbid symptoms with a MADRS total score greater than 22 and/or a HAM-A total score greater than 22; structured interview guides were used for MADRS and HAM-A ratings in the study.
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Review current psychiatric medications rather than requiring washout
The study allowed stimulant medications for ADHD and medications for other medical or psychiatric conditions, including depression or anxiety. This means viloxazine ER was used both alone and as add-on treatment, so clinicians can consider it in patients already receiving concomitant psychiatric medications while planning careful follow-up.
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Start viloxazine ER at 200 mg each morning
Participants were instructed to take viloxazine ER 200 mg once daily in the morning during week 1. This was the initial treatment step used in the phase 4 trial.
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Increase to 400 mg each morning in week 2
From week 2 onward, participants were instructed to take 400 mg once daily in the morning until the next investigator contact. The trial used this fixed early titration within a flexible-dose, real-world design.
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Reassess at weeks 4, 9, and 14
The study evaluated treatment response during televisits at weeks 4, 9, and 14 of treatment. At these follow-ups, clinicians can reassess ADHD severity with AISRS and CGI scales and also track depression and anxiety symptoms with MADRS and HAM-A or corresponding patient-reported measures, since symptom reductions were seen at all study visits.
Clinical Considerations
- This was an open-label, single-arm study without a comparator group, so treatment effects may be overestimated and should be interpreted descriptively.
- The study was not designed to determine whether improvement in depression or anxiety symptoms was a direct effect of viloxazine ER or secondary to improvement in ADHD symptoms.
- Concomitant medication changes and their impact on efficacy or safety were not evaluated.
- Generalizability may be limited because the study population was mostly White and female.
Bottom Line
In adults with ADHD plus prominent depression and/or anxiety symptoms, viloxazine ER was started at 200 mg each morning for 1 week and increased to 400 mg each morning with follow-up at weeks 4, 9, and 14, including in patients taking other psychiatric medications.
