Viloxazine hydrochloride (35604-67-2)

What is Viloxazine hydrochloride?

Viloxazine hydrochloride, sold under the brand name Qelbree and formerly as Vivalan among others, is a morpholine derivative and a member of the SNRI (Serotonin-Norepinephrine Reuptake Inhibitor) drug class. It is a noradrenergic drug prescribed to treat attention deficit hyperactivity disorder (ADHD) in children and adults. Viloxazine is a non-stimulant medication; it has no known misuse liability and is not a controlled substance.

In Europe, it was sold as an antidepressant from 1974 until 2002, when it was discontinued for commercial reasons. It was repurposed for the treatment of ADHD and reintroduced in April 2021 in the United States.

Mechanism of action 

• Viloxazine acts as a non-stimulant norepinephrine reuptake inhibitor (NRI). It works by increasing the levels of norepinephrine in the prefrontal cortex of the brain which helps in alertness, impulse control, and in the regulation of mood and behavior.
• It also modulates serotonin receptors, specifically 5-HT2B and 5-HT2C, thereby enhancing serotonin levels and contributing to mood stability.
• Additionally, Viloxazine increases dopamine levels in the prefrontal cortex and amygdala, and to a lesser extent, in the nucleus accumbens and helps in ADHD and to control impulsive behavior, and hyperactivity, and boost learning .

Uses

• Viloxazine is a selective norepinephrine reuptake inhibitor approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in individuals 6 years and older, including adults.
• Additionally, Viloxazine was formerly sold in the market as an antidepressant for the management of major depressive disorder.

Side effects

Side effects observed in children (aged 6-17 years) are as follows:

• Headache
• Somnolence
• Fatigue
• Nausea, Vomiting
• Upper respiratory tract infections
• Decreased appetite

Side effects observed in adults are as follows:

• Dry mouth
• Constipation
• Irritability
• Dizziness
• Tachycardia
• Gastroesophageal reflux disease

FAQs

Q. Is Viloxazine FDA-approved?

In April 2021, Qelbree (viloxazine) was licensed by the FDA to treat children and adults with attention-deficit hyperactivity disorder (ADHD).

Q. Is Viloxazine a controlled substance?

Viloxazine is not a controlled substance.

Q. Is Qelbree an antidepressant?

Qelbree is a member of the class of antidepressants known as serotonin-norepinephrine reuptake inhibitors. However, it is not authorized for use as a treatment for depression by the Food and Drug Administration (FDA).

Q. Where to purchase Viloxazine hydrochloride?

Macsen Labs is a GMP and ISO-certified manufacturer and supplier of high-quality Viloxazine hydrochloride.

Q. How does Viloxazine work?

 Viloxazine works by selectively inhibiting the norepinephrine transporter (NET), which increases norepinephrine levels in the brain. This helps improve attention, focus, and cognitive function, particularly in individuals with ADHD.

Q. Who should not take Viloxazine?

People having a history of serious heart conditions like arrhythmias and severe liver impairment and are allergic to viloxazine or any of its ingredients should avoid the viloxazine medication.

Q. What does viloxazine do?

It helps to manage ADHD by increasing the ability to pay attention and decreasing impulsiveness and hyperactivity in children 6 to 17 years of age with attention deficit hyperactivity disorder (ADHD). 

Q. Is Viloxazine addictive?

Viloxazine has low abuse potential and is not considered addictive. It does not cause the same “high” or dopamine surge seen with stimulant medications.

Q. Is Viloxazine a controlled substance?

Viloxazine is not a controlled substance in the U.S. It has a low potential for abuse or dependence.

Q. Is Viloxazine a stimulant?

Viloxazine (Qelbree) is a non-stimulant medication used in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults.

Q. What is Viloxazine used for?

Viloxazine is mainly used in the treatment of pulmonary arterial hypertension and to control the symptoms of ADHD.

Q. Which potentially serious adverse effect is associated with Viloxazine?

In severe cases, viloxazine may cause cardiovascular issues, suicidality, and mania; these effects have been reported particularly in teenagers using viloxazine.

Q. How long does Viloxazine take to work?

Generally, Viloxazine takes 1-2 weeks to show its effects and its full therapeutic benefits are typically observed after 4 to 6 weeks.

Resources

Viloxazine | Mechanism of action, ADHD & other Uses, Side effects