Does Qelbree (Viloxazine) cause suicidal ideation?

Qelbree (Viloxazine) and Suicidal Ideation Risk

Yes, Qelbree (viloxazine) does carry a risk of causing suicidal ideation, as clearly stated in its FDA-approved labeling which includes a warning about suicidal thoughts and behaviors.

FDA Warning for Suicidal Ideation

The FDA drug label for Qelbree contains specific warnings about suicidal thoughts and behaviors:

• Clinical trials showed higher rates of suicidal thoughts and behaviors in patients treated with Qelbree compared to placebo 1
• Among 1,019 pediatric patients (ages 6-17) in clinical trials:
  • 0.9% reported suicidal ideation or behavior on Qelbree
  • 0.4% reported suicidal ideation on placebo 1
• Among adult patients:
  • 1.6% reported suicidal ideation on Qelbree
  • 0% reported suicidal ideation on placebo 1

Risk Factors and Monitoring

The risk of suicidal ideation with Qelbree appears to be related to several factors:

• Patients treated with Qelbree had higher rates of insomnia and irritability, which may be precursors to suicidal thoughts 1
• Other potential precursor symptoms include depressed mood, anxiety, agitation, akathisia, mania, hypomania, panic attacks, impulsive behavior, and aggression 1

Clinical Management Algorithm

1. Before starting Qelbree:

   • Assess baseline suicide risk
   • Discuss the risk of suicidal ideation with patients and caregivers
   • Consider alternative medications if the patient has pre-existing suicide risk factors

2. During treatment with Qelbree:

   • Monitor closely for clinical worsening and emergence of suicidal thoughts/behaviors, especially:
     • During the initial few months of treatment
     • After dosage changes 1
   • Watch for precursor symptoms (insomnia, irritability, mood changes, agitation)
   • Have family members or caregivers monitor for emergence of suicidal ideation

3. If suicidal thoughts emerge:

   • Consider changing the therapeutic regimen
   • Potentially discontinue Qelbree, especially if symptoms are severe or abrupt in onset 1

Comparison to Other ADHD Medications

• Qelbree carries a similar boxed warning for suicidal ideation as atomoxetine (another non-stimulant ADHD medication) 2
• Like atomoxetine, Qelbree is a non-stimulant option for patients who cannot tolerate stimulant medications 2
• Clinical studies suggest Qelbree may have a faster onset of action (1-2 weeks) compared to atomoxetine (4 weeks) 2

Important Considerations

• Viloxazine is classified as a serotonin-norepinephrine modulator 2
• The mechanism of action may contribute to the risk of suicidal ideation, similar to other medications affecting serotonergic systems
• The FDA requires close monitoring of all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors 1

Clinical Pitfalls to Avoid

• Don't ignore early warning signs: Irritability, insomnia, and mood changes may precede suicidal ideation
• Don't fail to educate: Ensure patients and caregivers understand the need to report concerning symptoms immediately
• Don't overlook monitoring needs: Regular follow-up is essential, especially during initial treatment and after dose changes
• Don't miss the opportunity for risk mitigation: Consider more frequent monitoring for high-risk patients

Qelbree remains a useful treatment option for ADHD, but the risk of suicidal ideation must be carefully weighed against its benefits, with appropriate monitoring protocols in place.