| What is Azstarys? |
A prescription medication approved in the U.S. in 2023 for the treatment of attention‑deficit/hyperactivity disorder (ADHD). It’s a fixed‑dose combination of viloxazine (a selective noradrenergic reuptake inhibitor) and d‑amphetamine (a stimulant). |
| Is it approved in Canada? |
No, Azstarys is not currently approved by Health Canada (as of August 2026). Health Canada’s review is ongoing, and there’s no publicly available decision date. |
| How can Canadian patients access it? |
1. Compassionate Use / Special Access Program (SAP) – If a patient meets strict eligibility criteria (e.g., severe, treatment‑resistant ADHD and no suitable alternatives), a clinician can apply for an SAP request. 2. Clinical Trial – Patients may enroll in a registered clinical study evaluating Azstarys in Canada. 3. Importation – Some individuals obtain the drug from the U.S. via a “medical tourism” or personal import route, but this is not officially sanctioned, may breach regulations, and poses risks (e.g., counterfeit products). |
| Why might it not be approved yet? |
Health Canada evaluates clinical data, labeling, safety, and manufacturing standards. Approval timelines can vary; the FDA’s 2023 approval may accelerate the Canadian review, but final decisions can still take several months to a year. |
| What are the dosing guidelines (U.S. label)? |
• Starting dose: 40 mg once daily (morning).
• Titration: Increase by 40 mg at 4‑7‑day intervals, as needed and tolerated.
• Maximum dose: 120 mg/day (80 mg of viloxazine + 40 mg of d‑amphetamine). |
| Typical side‑effects |
• Stimulant‑related: insomnia, decreased appetite, weight loss, increased heart rate, elevated blood pressure.
• Viloxazine‑related: nausea, abdominal pain, dizziness, anxiety.
• Rare: mood changes, aggression, hallucinations. |
| Contraindications / Precautions |
• Cardiovascular disease: uncontrolled hypertension, arrhythmia, significant cardiac disease.
• Psychiatric disorders: severe anxiety, bipolar disorder, or history of substance abuse (amphetamines carry abuse potential).
• Pregnancy / breastfeeding: limited data; consider risk vs. benefit. |
| Drug interactions |
• MAO inhibitors: avoid.
• Sympathomimetics (e.g., pseudoephedrine): additive cardiovascular effects.
• SSRIs / SNRIs: may increase risk of serotonin syndrome when combined with viloxazine. |
| Monitoring |
• Baseline BP & pulse; follow‑up at 2–4 weeks and then monthly.
• Weight & growth monitoring in children.
• Neuro‑psychiatric assessment for mood changes. |
| Alternative ADHD meds approved in Canada |
• Stimulants: methylphenidate (Concerta, Ritalin), d‑amphetamine (Adderall XR, Dexedrine), lisdexamfetamine (Vyvanse).
• Non‑stimulants: atomoxetine (Strattera), guanfacine (Intuniv), clonidine (Kapvay). |
| Practical next steps for a Canadian patient |
1. Discuss with your physician whether a SAP request is appropriate.
2. Ask about clinical trials that might offer Azstarys access.
3. Explore approved alternatives if immediate treatment is needed.
4. Stay informed – keep an eye on Health Canada’s drug approval announcements. |