Is Adzenys a welcome new addition to the list of available prescription ADHD medications?
Or, as some experts fear, is Adzenys little more than candy-flavored evidence that children are being zombified by over-medication?
Just as bad, is Adzenys so “tasty and easy to take” that new generations of amphetamine addicts are being created?
And while the truth probably falls somewhere in the middle, that still leaves ample room for some very real concerns.
What You Need to Know about Adzenys
“I am not a big fan of controlled substances that come in forms that can be easily abused – and certainly, a chewable drug falls into that category.”
~ Dr. Mukund Gnanadesikan, a child and adolescent psychiatrist in Napa, California
In January of last year, NEOS Therapeutics, a pharmaceutical company based in Dallas, TX, was granted approval by the Food and Drug Administration for Adzenys XR-ODT, a pure amphetamine central nervous system (CNS) stimulant given as treatment for Attention Deficit Hyperactivity Disorder (ADHD) in adults and children age 6 and up.
This formulation comes in fast-dissolve/chewable amphetamine tablets that provide both immediate-and- extended-release of the medication—half immediately, and the other half throughout the rest of the day.
Adzenys is the first fast-dissolve ADHD medication, and is a viable option for anyone who has difficulty swallowing pills.
Adzenys XR-ODT is available in six different dosages, which allows the prescription to be individually-tailored to the patient. Because most ADHD patients are children, Adzenys XR-ODT tablets are orange-flavored.
In September 2017, a new formulation was approved by the FDA—Adzenys ER, a pure amphetamine extended-release liquid. It is supposed to go on sale in early 2018.
All About ADD
ADHD – formerly Attention Deficit Disorder (ADD) – is identified by symptoms of impulsiveness, hyperactivity, and inattention. An ADHD diagnosis is likely when four factors are present:
- Symptoms appear before the age of 12
- Symptoms show up in multiple settings – at home, school, daycare, etc.
- Symptoms disrupt normal daily life.
- Symptoms can’t be explained by another condition.
ADHD is one of the most-frequently-seen childhood behavioral disorders, according to the Centers for Disease Control and Prevention.
- It affects around 11% of US children between the ages 4 and 17.
- In 2003, the ADHD rate was only 7.8%.
- Boys have higher rates of ADHD than girls – 13% to 5%.
- 6.4 MILLION American children have been diagnosed with ADHD at some point.
- That is a 53% increase over the past decade.
What About Adult ADHD?
ADHD is a disorder that firsts manifests during childhood, but up to two-thirds of children with ADHD will outgrow it by the time they are adults.
According to the National Institute of Mental Health, 8% of adults 18-44 have a lifetime prevalence of ADHD, and 41% of these cases are considered “severe”. Adult ADHD patients often suffer multiple recurring problems because of their condition—relationship issues, academic difficulties, infrequent employment, financial struggles, and legal entanglements.
Not surprisingly, 4 out of 5 adult ADHD sufferers also have a co-occurring emotional disorder such as depression or anxiety.
Is Adzenys an Effective ADHD Medication?
Stimulants are the best-known and most-prescribed drugs for the treatment of ADHD. Adzenys and similar medications work quickly and are extremely effective – 80% of ADHD patients show fewer symptoms.
As an amphetamine, Adzenys works by increasing the activity of several hormones and neurotransmitters in the brain:
- Dopamine – reward, learning, motivation, and attention
- Epinephrine – long-term memory and stress response
- Histamine – decreases blood pressure and reduces stress
- Norepinephrine – memory, alertness, and attention
- Serotonin – happiness and well-being
Pea 2011 report, when ADHD patients take their prescription stimulants as directed, they reduce the likelihood of comorbid substance abuse.
What Are the Risks of Taking Adzenys?
Biochemically, Adzenys is roughly equivalent to another ADHD medication–Adderall, which is also an amphetamine. Even when used as directed, ADHD prescription stimulants are associated with increased physical and psychiatric health risks, including:
- Increased Blood Pressure
- Syncope—interrupted blood flow to the brain, leading to “light-headedness” or blacking out
- Arterial Spasms
- Heart Attack
- Sudden Death
- Worsening of Pre-Existing Psychosis
- Manic Episodes among Bipolar Patients
- Weight Loss
- Impaired Growth among Pediatric Patients
- Serotonin Syndrome
Is Adzenys Another Sign of Over-Medication?
“It’s true ADHD has become more ‘fashionable,’ for lack of a better word, and that people are much more aware of it. One of the reasons is direct marketing to consumers by drug companies. Parents say, ‘I hope it’s ADHD, because then it can be fixed.”
~ Dr. Xavier Castellanos, Professor in the Department of Child and Adolescent Psychiatry at the Child Study Center, NYU Langone Medical Center
The Centers for Disease Control and Prevention has advised parents of ADHD-diagnosed children to try behavioral therapy as a first-line intervention before resorting to prescription medications. However, too many parents – and physicians – choose pharmaceuticals as their preferred option.
As a result, 75% of children with ADHD are prescribed medication to help manage symptoms. A generation ago, in 1990, approximately 600,000 American children were receiving prescription ADHD. But by 2013, the number has skyrocketed to 3.5 MILLION.
Need further proof?
The ADHD drug market is booming:
- 2006: ADHD medication sales totaled $4.6 billion.
- 2015: Sales reached $12.7 billion – nearly triple the totals of a decade earlier.
- 2020: Projected sales of $17.5 billion.
Adzenys Delivers Convenience with a Possible Cost
“…an orally-disintegrating amphetamine for kids by the morally-disintegrating FDA. What’s next? Gummy bears?”
~ Dr. Alexander Papp, University of California, San Diego
Adzenys XR-OT comes in convenient blister packs instead of pill bottles that can be made child-proof. And in 2018, Adzenys ER will be available in liquid form.
The easy-to-take formulations and packaging increase the risk that younger children will be able to gain access to medications that taste like orange candy. Fatal Adzenys overdoses could be the result.
But this convenience and portability also make it that much easier for people to misuse or abuse their medication. Blister packs are easier to transport and sell than pill bottles. Dr. Gnanadesikan says manufacturing a once-a-day to local ADHD drug is “a recipe for people to request it and then sell it.”
This is extremely relevant, considering college-age young adults are TWICE as likely to misuse Adzenys, Adderall, Ritalin, and other prescription stimulants than any other age group.
How Addictive Is Adzenys?
Adzenys is 100% amphetamine, just like Adderall, potentially positioning it as a popular drug of abuse. Prescription stimulants are:
- Euphoriants – They create a pleasurable sense of extreme well-being.
- Aphrodisiacs – They increase sex drive and enhance the sexual experience.
- Physical performance enhancers – At lower therapeutic doses, prescription stimulants reportedly improve endurance and muscle strength.
- Cognition enhancers/Study aids – Some reviews suggest that low doses of prescription stimulants increase memory and attention in otherwise-healthy adults.
Adzenys is a Schedule II controlled substance, specifically because of its potential for abuse. At normally-prescribed doses, addiction to Adzenys isn’t very likely, even when it is taken long-term.
But on the other hand, when Adzenys is misused at higher non-medical or recreational doses, dependence and addiction are almost certain.
Among high-dose stimulant abusers, nearly 9 out of 10 will experience symptoms of withdrawal within 24 hours following the last use. Amphetamine withdrawal symptoms can persist up to a month.
One underreported danger hazard of chronic prescription stimulant abuse is developing a tolerance. This leads to higher and higher doses that can eventually result in an overdose. Amphetamine-tolerant abusers will consume up to 5 g per day – 100 times the recommended therapeutic dose.
Prescription ADHD Stimulant Abuse Statistics
Teenagers and young adults misuse prescription amphetamines like Adzenys at a higher rate than you might otherwise suspect. Experimentation and non-medical use typically begins in early adolescence, continuing through high school and college.
There are several stages at which young people’s perceptions about ADHD medication misuse change, subsequently affecting their behaviors.
- Percentage of students who think that it is “easy” to obtain prescription stimulants:
- 8th-grade – 15%
- 10th grade – 28.5%
- 12th grade – 47%
- 40% of teenagers think that misusing prescription drugs is safer than using illicit drugs.
- Nearly 1 out of 3 teens don’t believe prescription medications are addictive.
- Percentage of college students who are offered ADHD stimulants non-medically:
- Freshmen – 36%
- Sophomores – 38%
- Juniors – 41%
- Seniors – 32%
- At any point during college – 62%
- Percentage of college students who use ADHD stimulants non-medically:
- Freshmen – 13%
- Sophomores – 18%
- Juniors – 21%
- Seniors – 16%
- At any point during college – 31%
- 95 % of college students who misuse prescription stimulants fake ADHD symptoms to get their medication.
- 40% of prescription ADHD stimulant misuse occurs during the days immediately preceding midterms and final exams.
- 9 out of 10 college students who take prescription ADHD drugs without a prescription are “heavy” drinkers and engage in episodic binge-drinking.
Adzenys – The Study Aid That Isn’t
Prescription stimulants like Adzenys and Adderall are a popular choice among older teenagers and college students of their supposed benefits to memory and focus. These effects make ADHD medications desirable as study aids.
But while small cognitive gains have been recorded in controlled settings, there is virtually no evidence that using ADHD amphetamines provides any academic benefits in the real world.
- The college students who are most likely to abuse ADHD medications (and other substances) already have low GPAs. When they take Adzenys, Adderall, or Ritalin to help them focus, the gains they realize might just be attributable to studying, rather than the drug.
- Because amphetamine users tend to drink excessively and use other drugs, any improvements would most likely be wiped out by that concurrent substance abuse.
- Prescription amphetamine-misusing students skip more than 16% of their scheduled classes, compared to about 9% among nonusers. In other words, the supposed “improved focus” doesn’t carry over.
- In a 2013 University of Pennsylvania study, participants taking ADHD drugs demonstrated almost NO measurable cognitive improvement. Yet participants still believed their performance had improved.
This suggests that any feeling of greater focus and accomplishment might in fact have less to do with any actual cognitive improvement and more to do with the euphoria amphetamines produce. In other words, Adzenys and other stimulants make study sessions more enjoyable, not more productive.
Prescription ADHD Medication Abuse and Cross-Addiction
The misuse of Adzenys and other prescription stimulants “primes” the user’s brain, making them more susceptible to substance abuse and addiction. Compared to non-users, college students who use ADHD drugs non-medically are far more likely to have used/misused other substances within the past year:
- Marijuana – 80% vs 27%
- Cocaine – 29% vs 3.6%
- Benzodiazepines – 24.5% vs 3%
- Prescription Opioids – 45% vs 9%
Stimulant m the purchase else, then youisuse and alcohol abuse also tend to go together. 90% of young adults who use ADHD drugs non-medically are also heavy drinkers who regularly engage in problematic behaviors such as binge-drinking.
Long-term amphetamine abusers often get trapped in a cycle of multi-drug dependency. Stimulant use causes insomnia and anxiety, which results in a need for sedating sleeping pills and tranquilizing anti-anxiety benzodiazepines.
Even worse, regular use leads to tolerance – a need for ever-increasing dosages of each drug in order to achieve the same desired effect. This is extremely dangerous, because 98% of fatal overdoses involve multiple substances.
What Are the Risks of ADHD Medication Abuse?
Chronic abuse of amphetamines such as Adzenys can seriously affect your mental and physical health:
- Sexual dysfunction
- Severe insomnia
- Unhealthy weight loss
- Vision problems
- Rash/Blisters on the skin
- Digestive issues
- Expulsion from school
- Arrest/Imprisonment – fraudulently obtaining a prescription by faking ADHD symptoms is a felony
- Heightened risk of multi-substance abuse
The Bottom Line about Adzenys
Millions of American children, teens, and adults struggle with ADHD. For many, medications like Adzenys, Adderall, Vyvanse, and Ritalin, combined with supportive counseling, is the most effective way to manage symptoms.
But keep in mind – amphetamine-based ADHD medications have a high potential for misuse, dependence, and addiction. And these risks are magnified in young people, because of the effect drugs have on the still-developing brains of adolescents and young adults.
So, in answer to the three questions of concern originally asked –
YES, Adzenys is a welcome new ADHD medication that offers a new option for people who find it hard to swallow pills.
YES, over-medication of children as a valid concern. Parents are urged to seek out other, non-pharmaceutical solutions before turning to prescription stimulants.
YES, because the risk for drug divergence is so high, parents should make sure that their child takes their ADHD medication properly. It is also good idea to learn the warning signs of prescription drug abuse.
If you or someone you care about are having problems because you were prescribed Adzenys or any other prescription ADHD stimulant, you should contact a reputable drug rehab program to discuss your options.