What are the benefits, side effects, and risks of using Qelbree (Viloxazine) to treat Attention Deficit Hyperactivity Disorder (ADHD)?

From the Guidelines

Qelbree (Viloxazine) is a viable treatment option for Attention Deficit Hyperactivity Disorder (ADHD) in children and adults, offering significant reduction in ADHD symptoms with once-daily dosing and lower abuse potential compared to stimulant medications. The benefits of Qelbree include its efficacy in improving attention and reducing impulsivity by inhibiting norepinephrine reuptake in the brain. According to the most recent study 1, Qelbree can be considered as an agent in the treatment of ADHD following a risk-benefit discussion, acknowledging that there is no information published on its safety in pregnancy and there is limited data on its efficacy for the treatment of ADHD in adults.

Benefits of Qelbree

• Significant reduction in ADHD symptoms
• Once-daily dosing (200-600mg for adults)
• Lower abuse potential compared to stimulant medications
• Can be taken with or without food
• Does not require controlled substance prescribing restrictions

Side Effects and Risks

• Common side effects include decreased appetite, insomnia, headache, fatigue, nausea, and irritability, which are typically mild to moderate and often improve over time
• The most serious risk is increased suicidal thoughts or behaviors, particularly in young people
• Other risks include potential for increased blood pressure and heart rate, possible drug interactions with MAOIs
• The medication should be avoided in patients with severe cardiovascular conditions

Dosage and Administration

• The usual starting dose of Qelbree is 200 mg po once daily
• Titration can be done by 200 mg increments at weekly intervals based on response and tolerability, with a maximum daily dose of 600 mg/d 1
• Qelbree takes 1-2 weeks to show initial effects, with full benefits appearing after 4-6 weeks of consistent use

It is essential to weigh the benefits and risks of Qelbree and consider alternative agents, especially in patients with severe cardiovascular conditions or those who are pregnant or breastfeeding, due to the limited data available on its safety and efficacy in these populations 1.

From the FDA Drug Label

In clinical studies, higher rates of suicidal thoughts and behavior were reported in patients with ADHD treated with Qelbree than in patients treated with placebo. Qelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. QELBREE can cause serious side effects, including: Increased risk of suicidal thoughts or actions. QELBREE may increase suicidal thoughts or actions in children and adults with attention deficit hyperactivity disorder (ADHD), especially within the first few months of treatment or when the dose is changed. Somnolence and Fatigue Advise patients about the potential for somnolence (including sedation and lethargy) and fatigue. Effects on Weight Advise patients and their caregivers that Qelbree may affect weight and that weight should be monitored while using Qelbree Increased blood pressure and heart rate.

The benefits of using Qelbree (Viloxazine) to treat Attention Deficit Hyperactivity Disorder (ADHD) include:

• Treatment of ADHD in adults and pediatric patients 6 years and older 2 The side effects of using Qelbree (Viloxazine) to treat ADHD include:
• Suicidal thoughts or actions
• Somnolence (including sedation and lethargy) and fatigue
• Effects on weight
• Increased blood pressure and heart rate The risks of using Qelbree (Viloxazine) to treat ADHD include:
• Higher rates of suicidal thoughts and behavior in patients with ADHD treated with Qelbree than in patients treated with placebo 2
• Increased risk of suicidal thoughts or actions, especially within the first few months of treatment or when the dose is changed 2

From the Research

Benefits of Qelbree (Viloxazine) in Treating ADHD

• Qelbree (Viloxazine) has been shown to be effective in treating Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents, and adults 3, 4, 5, 6, 7.
• The medication has been found to improve attention-deficit/hyperactivity disorder symptomology, executive function, and overall clinical illness severity in adults 3.
• Viloxazine has a relatively rapid onset of action, sustained symptom improvement, and clinical benefit in ADHD-associated impairments (functional and social) 4.
• The medication has been approved by the FDA for the treatment of ADHD in children aged 6-17 and has been found to be well-tolerated in adults with ADHD 3, 5.

Side Effects of Qelbree (Viloxazine)

• The most common treatment-related adverse events associated with Qelbree (Viloxazine) include insomnia, fatigue, nausea, decreased appetite, dry mouth, and headache 3, 6.
• Somnolence, decreased appetite, and headache have also been reported as common side effects in children and adolescents 6.
• Viloxazine has been found to have a decreased chance of substance abuse, drug dependence, and withdrawal symptoms upon cessation of therapy compared to stimulants 7.

Risks of Qelbree (Viloxazine)

• Viloxazine may not be suitable for all patients, particularly those with a history of suicidal ideation or depression 6.
• The medication may interact with other drugs, and patients should be monitored closely for any adverse reactions 7.
• As with any medication, there is a risk of discontinuation due to adverse events, which has been reported to be around 9% in adults with ADHD 3.