Viloxazine: Non-Stimulant Medication now FDA Approved for Adult ADHD
Viloxazine ER (Qelbree) was initially approved for pediatric ADHD and now had received FDA approval for the management of ADHD in adult patients. We have summarized this medication in the following sections:
- Indication
- Mechanism of action
- Important considerations before initiating treatment.
- How to Dose?
- When to adjust the dose?
- Can you open the capsule & sprinkle it?
- Most commonly observed adverse events.
- Important Drug Interactions.
- Any risk of abuse or dependence?
INDICATIONS:
- ADHD in adults and pediatric patients 6 years and older.
MECHANISM OF ACTION:
- Norepinephrine Reuptake Transporter Inhibition.
- The first 2-bead Microtrol™ Technology delivery of nonstimulant viloxazine for 24-hour patient exposure
IMPORTANT CONSIDERATIONS BEFORE INITIATING:
(1) Monitor Heart Rate & Blood Pressure:
- before adding, after dose increase & periodically.
- can cause an increase in heart rate & diastolic blood pressure.
(2) Personal or family history of depression or suicide:
- Higher rates of suicidal thoughts and behaviors were reported in pediatric and adult patients with ADHD treated with Qelbree than in patients treated with placebo.
(3) Personal or family history of bipolar disorder:
- may induce a manic or mixed episode in patients with bipolar disorder.
(3) Fatigue & Somnolence:
- Advise patients to use caution when driving or operating hazardous machiner.
HOW TO DOSE?
(1) AGE 6-11 YEARS:
- Starting Dose: 100 mg/day
- Titrate: 100 mg/week
- Maximum: 400 mg/day
(2) AGE 12-17 YEARS:
- Starting Dose: 200 mg/day
- Titrate: 200 mg/week
- Maximum: 400 mg/day
(3) AGE >18 YEARS:
- Starting Dose: 200 mg/day
- Titrate: 200 mg/week
- Maximum: 600 mg/day
(4) GERIATRIC PATIENTS:
- Not studies
WHEN TO ADJUST THE DOSE?
RENAL IMPAIRMENT:
- Starting Dose: 100 mg/day
- Titrate: 50-100 mg/week
- Maximum: 200 mg/day
- Renal excretion is the primary route of excretion of viloxazine.
CAN YOU OPEN THE CAPSULE & SPRINKLE IT?
- Swallow the capsules whole, or open the capsule and sprinkle the entire contents over a teaspoonful or tablespoonful of pudding or applesauce.
- Consume the food mixture in its entirety, without chewing, within 15 minutes for pudding, or within 2 hours for applesauce.
- Do not store for future use.
MOST COMMONLY OBSERVED ADVERSE EVENTS:
PEDIATRIC PATIENTS:
- Somnolence, Fatigue
- Decreased appetite, nausea, vomiting
- Insomnia
- Irritability
ADULT PATIENTS:
- Insomnia
- Headache
- Somnolence, Fatigue
- Nausea, Decreased appetite, Dry mouth & Constipation
IMPORTANT DRUG INTERACTIONS:
Monoamine Oxidase Inhibitors (MAOI):
- CONTRAINDICATED: Concomitant use of Qelbree with an MAOI or within 2 weeks after discontinuing an MAOI is contraindicated.
- Risk of Hypertensive Crisis.
MODERATE SENSITIVE CYP1A2 SUBSTRATES:
- Viloxazine is a strong CYP1A2 inhibitor.
- Moderate sensitive 1A2 substrate NOT RECOMMENDED with Viloxazine.
ANY RISK OF ABUSE OR DEPENDENCE?
- Once-daily Qelbree shows no evidence of abuse potential in studies: minimizing the risk of treatment abuse, misuse, or diversion.
- Viloxazine was found to be free of physical drug dependence in 5 animal models of abuse liability.
- No withdrawal symptoms or signs of dependence were reported as AEs during human clinical trials.
REFERENCES:
1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.
2. Supernus Pharmaceuticals. Advanced Drug Delivery Systems. Rockville, MD: Supernus Pharmaceuticals, Inc.
3. Data on file, Supernus Pharmaceuticals.
4. Yaganita T, Wakasa Y, Kiyohara H. Drug dependence potential of viloxazine hydrochloride tested in rhesus monkeys. Pharmacol Biochem Behav. 1979;12(1):155-161.
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