Azstarys: The New Treatment for ADHD?

Attention-Deficit/Hyperactivity Disorder (ADHD) is one the most common neurodevelopmental disorders of childhood. According to the CDC, in 2016 about 6.1 million (9.4%) of children were diagnosed with ADHD. However, what is also interesting about this condition is that it not only affects children but also adults. About four to five percent of adults in the United States are actually diagnosed with ADHD, but there are many more that are undiagnosed and untreated. 

What are the signs and symptoms of children and adult ADHD? 

The signs and symptoms in children and adults might seem similar but can also differ at the same time. 

In children

In children it is best to note what they experience under both inattentiveness and hyperactivity and impulsivity, because many times ADHD may manifest as behavioral problems. 

InattentivenessHyperactivity and Impulsivity 
Having short attention span and easily distractedBeing unable to sit still 
Appearing forgetful or losing thingsConstantly fidgeting
Being unable to stick to tasks that are tedious or time-consumingBeing unable to concentrate on tasks
Appearing unable to listen to or carry out instructions Excessive physical movement or talking
Constantly changing activity or tasksNot able to wait their turn
Having difficulty organizing tasksActing without thinking 
Interrupting conversations
Little or no sense of danger 

In adolescents and adults

Signs and symptoms of adolescent and adult ADHD are slightly different from what children may experience. The following to look out for are: 

  • Impulsiveness 
  • Disorganizing and problems prioritizing 
  • Poor time management 
  • Problems focusing on tasks
  • Excessive activity or restlessness
  • Poor planning
  • Frequent mood swings
  • Problems following through and completing tasks
  • Troubles coping with stress 

How is ADHD treated? 

Usually if diagnosed in children and adolescents, behavioral therapy is one of the first steps in helping with the management of ADHD. However, sometimes behaviors become such a problem both at home and school and other people around them are affected by their disruptions, that medication is needed. 

There are two different types of ADHD medications, stimulants and non-stimulants. Stimulants are the most widely used. The benefits of these are they are fast-acting and 70-80% of children with ADHD have experienced fewer symptoms. The disadvantage is it can cause the patient to experience insomnia if taken too late during the day. Non-stimulant medications do not work as quickly as stimulants but their effects last up to 24 hours. The disadvantages that patients may experience are typically decreased appetite and sleep issues with these medications. 

What is Azstarys? 

Azstarys is a central nervous system (CNS) stimulant indicated for ADHD in patients 6 years and older. Approved in 2021, Azstarys contains both serdexmethylphenidate and dexmethylphenidate and this combination allows it to work in a different way than other stimulant medications. The dexmethylphenidate ingredient works by providing immediate release of the stimulant in the morning. Whereas, serdexmethylphenidate is a prodrug and needs to be metabolized in the body to its active form, dexmethylphenidate, in order for it to exert its effects and allows for extended release of the stimulant throughout the day. Therefore Azstarys provides both immediate release in the morning and continuous release throughout the day. 

How is Azstarys best taken? 

Unlike other stimulant ADHD medications, Azstarys is taken without regard to food, therefore it can be taken with breakfast in the morning. The starting dosage for patients aged 6 and up are 39.2mg/7.8mg and increased to the maximum dosage of 52.3mg/10.4mg or can be decreased to 26.1mg/5.2mg. Azstarys capsules should be swallowed whole or contents of capsules can be emptied and placed in applesauce. 

What are the side effects of Azstarys?

Just like other methylphenidate products, the most common adverse effects experienced are:

  • Appetite decrease
  • Insomnia 
  • Nausea and vomiting
  • Dyspepsia 
  • Abdominal pain
  • Weight decreased 
  • Anxiety 
  • Dizziness
  • Irritability 
  • Tachycardia
  • Increased Blood pressure 

What are contraindications and warnings/precautions? 

The contraindications of Azstarys are known hypersensitivity to sermethylphenidate, methylphenidate products and concurrent treatment with monoamine oxidase inhibitors (MAOI), or use of MAOI within preceding 14 days. 

Warnings and precautions of Azstarys are: 

  • Serious cardiovascular reactions
  • Blood pressure and heart rate increases 
  • Psychiatric adverse reactions
  • Priapism
  • Peripheral vasculopathy, including Raynaud’s Phenomenon
  • Long-term suppression of growth

It should be noted as well that Azstarys, just like other ADHD is considered a CII medication which means it does have a high potential for abuse and dependence. 

Reference: 

  1. Azstarys [package insert]. Grand Rapids,MI: Corium Inc.; 2021.