Azstarys (serdexmethylphenidate and dexmethylphenidate) for adults

Azstarys is a once-daily capsule that pairs two ingredients: dexmethylphenidate, the active form of methylphenidate found in Focalin, and serdexmethylphenidate, a prodrug that the body turns into dexmethylphenidate. It is newer than most methylphenidate products, and its adult approval rests on a different kind of evidence than older drugs such as Concerta. This page summarizes the current FDA label (effective May 2026, checked on DailyMed October 19, 2026). It gives no doses and is not advice to start, stop or switch a medication.

What Azstarys is

• Active ingredients: serdexmethylphenidate and dexmethylphenidate, in a fixed ratio in each capsule.
• Class: central nervous system (CNS) stimulant, methylphenidate family.
• How it works: the label says serdexmethylphenidate is a prodrug of dexmethylphenidate and is likely converted mainly in the lower gastrointestinal tract. The label states that the mode of therapeutic action in ADHD "is not known."
• Approval: FDA's Drugs@FDA database shows the original approval of the Azstarys application (NDA 212994) on March 2, 2021.
• Manufacturer on the current label: Commave Sub, LLC.

Prodrugs are explained alongside other release designs in extended-release ADHD medications explained. Another stimulant prodrug, lisdexamfetamine, belongs to the amphetamine family and is covered in Vyvanse for adults.

Is Azstarys approved for adults?

Yes. The indication is ADHD "in patients 6 years of age and older," with no upper age limit, and the label includes dosing instructions for adults. What is worth knowing is how adult effectiveness was established. The label says the efficacy of Azstarys in adults and teenagers 13 to 17 "was established by pharmacokinetic bridging" to dexmethylphenidate extended-release capsules. In plain terms, the company showed that Azstarys produces blood levels of dexmethylphenidate similar to an already approved product, rather than running a separate adult efficacy trial. The controlled efficacy study described in the label was in children aged 6 to 12.

Bridging is an accepted regulatory approach, and it is not a reason to doubt the approval. It does mean the label has less adult-specific trial data than a product like Concerta or Focalin XR, which describe trials in adults.

How it is taken

According to the label, Azstarys is taken by mouth once daily in the morning, with or without food. The capsule can be swallowed whole, or opened and its contents sprinkled on applesauce or added to water. The label also warns that, "to avoid substitution errors and overdosage," Azstarys should not be substituted for other methylphenidate products on a milligram-per-milligram basis. Any switch to or from another methylphenidate product is something for the prescriber to plan.

Controlled substance status

Azstarys has an unusual scheduling note. The label says it contains dexmethylphenidate, a Schedule II controlled substance, and serdexmethylphenidate, a Schedule IV controlled substance. Federal regulations place any mixture that contains a listed Schedule II stimulant in Schedule II unless it is specifically excepted or listed in another schedule (21 CFR 1308.12(d)), so the Schedule II prescription rules described below are the ones to expect. Your pharmacist can confirm how a specific prescription is handled. The categories are explained in ADHD medication schedules.

Boxed warning

Azstarys carries the boxed warning shared by all prescription stimulants: a high potential for abuse and misuse, which can lead to a substance use disorder including addiction, and a risk of overdose and death with misuse. Prescribers are told to assess each patient's risk before prescribing and to keep monitoring. The FDA required this class-wide wording on May 11, 2023.

Side effects

Based on data from other methylphenidate products, the label lists the most common adverse reactions (more than 5% and twice the placebo rate) as decreased appetite, insomnia, nausea, vomiting, indigestion, abdominal pain, weight loss, anxiety, dizziness, irritability, mood swings (affect lability), fast heart rate and increased blood pressure. The patient Medication Guide lists the same effects in everyday words. See ADHD medication side effects in adults.

Other warnings

• Avoid use in people with known serious heart disease; monitor blood pressure and pulse.
• Screen for risk of mania before starting; report new psychotic or manic symptoms.
• Priapism, circulation problems in fingers and toes (including Raynaud's phenomenon), glaucoma and raised eye pressure, and tics are covered in the warnings section.

For cardiovascular questions, see ADHD medication, heart health and blood pressure.

Who should not take it

The label lists two contraindications: known hypersensitivity to serdexmethylphenidate, methylphenidate or another ingredient (bronchospasm, rash and itching have been reported with Azstarys), and treatment with a monoamine oxidase inhibitor (MAOI) now or within the past 14 days, because of the risk of hypertensive crisis.

Interactions

The label's interaction table names MAOIs, blood pressure medicines (whose effect may be reduced), halogenated anesthetics used during surgery, and risperidone. Bring a full list of your medicines and supplements to each visit. Product-by-product details are in ADHD medication drug interactions.

Pregnancy and breastfeeding

The label says there are no available data on Azstarys use in pregnant women to evaluate drug-associated risk, and it points to the National Pregnancy Registry for ADHD medications. For breastfeeding, there are no data on serdexmethylphenidate in human milk; methylphenidate is known to pass into milk in small amounts, with no reported adverse effects on infants, and long-term effects are unknown. LactMed has a summary for methylphenidate. Planning around pregnancy is covered in ADHD in pregnancy and postpartum.

Generic availability and cost

As of October 19, 2026, FDA's Drugs@FDA database listed only the brand application for serdexmethylphenidate, with no approved generic version. Ask your plan how it covers Azstarys, whether prior authorization is needed, and whether it prefers a generic methylphenidate product.

New York and New Jersey rules

Schedule II prescriptions cannot be refilled in either state. New York limits a prescription to a 30-day supply unless it is written for a condition the state allows up to three months for, which includes attention deficit disorder; see New York's rules for ADHD stimulant prescriptions. New Jersey limits each prescription to 30 days, with multiple dated prescriptions allowed up to 90 days, and since July 8, 2026 requires an in-person visit within 30 days for adults located in New Jersey who start a Schedule II stimulant by telehealth; see New Jersey's ADHD medication rules.

Questions to ask your prescriber

• What would Azstarys offer me compared with a generic methylphenidate or dexmethylphenidate product?
• How will a switch from my current medication be handled, since products are not swapped milligram for milligram?
• Will my insurance cover it, and is prior authorization needed?
• Can I open the capsule if swallowing is hard for me?

Dr. Shershow provides adult ADHD evaluation and, when medication is appropriate, ongoing medication management. See adult ADHD treatment.