Qelbree

The active ingredient in Qelbree is viloxazine. It is a non-stimulant ADHD medication and works as a selective norepinephrine reuptake inhibitor (SNRI). Its mechanism of action consists of increasing levels of norepinephrine, a chemical messenger found in the brain, by blocking a protein called pre-synaptic norepinephrine transporter to reduce ADHD symptoms.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Qelbree. However, the following is a synopsis of the general guidelines for the use of Qelbree:

• Qelbree is typically taken once daily by mouth with or without food.
• Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce.
• Use caution when driving or operating hazardous machinery due to potential somnolence and fatigue.

The most common side effects of Qelbree seen in clinical trials as compared to placebo include:

• Tiredness.
• Sleepiness.
• Decreased appetite.
• Somnolence.
• Nausea.
• Vomiting.
• Trouble sleeping (insomnia).
• Irritability.
• Headache.
• Dry mouth.
• Constipation.

Some individuals may experience serious side effects while using Qelbree. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Allergic reaction - swelling, itching, hives.
• Increase in blood pressure.
• Increase in heart rate.
• Hypomania or manic episodes in patients with bipolar disorder.
• Increased risk of suicidal thoughts and behaviors.

These are not all of the possible side effects of Qelbree. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Qelbree, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have (or there is a family history of):

• High blood pressure.
• Heart rate problems.
• Kidney problems.
• Depression.
• Suicidal thoughts.
• Mania or hypomania.
• Bipolar disorder.

Boxed Warning

• In pediatric patients treated with Qelbree, higher rates of suicidal thoughts and behavior were observed than in patients treated with placebo.

• Associated administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range.
• Associated use of monoamine oxidase inhibitors (MAOI) within the past 2 weeks.

In clinical studies, ADHD symptoms were improved in as early as 1 week in children and in as early as 2 weeks in adults. However, it may take 4 to 8 weeks to get the full benefit once the right dose is determined.

When Qelbree is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Monoamine oxidase inhibitor (MAOI) within the past 2 weeks (isocarboxazid and others).
• Alosetron.
• Duloxetine.
• Ramelteon.
• Tasimelteon.
• Tizanidine.
• Theophylline.
• Atomoxetine.

Dosage forms of Qelbree include:

• Extended-release oral capsules - 100mg, 150 mg, and 200 mg.

Store at room temperature and keep out of reach of children.

Supernus Pharmaceuticals, Inc. is the pharmaceutical company that manufactures Qelbree.

There are no generic versions available of the brand name Qelbree.

Do not stop or adjust your use of this medication without first consulting with your doctor.

It is best to discontinue this medication when pregnancy is recognized since it may harm you or your unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown if this medication passes into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.