Why Isn’t Modafinil More Widely Prescribed for ADHD in the US?

Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders usually first diagnosed in childhood & often lasts into adulthood. Patients with this condition may have difficulty paying attention, depression, controlling impulsive behaviors, or be overly active. There is no cure for this disorder, but there exist some medications that can help combat its symptoms. Adderall & modafinil are some of them. They are central nervous system (CNS) stimulants or psychostimulants. These meds have similar properties & applications, and they both are listed as controlled substances by the US Drug Enforcement Administration.

Adderall is a brand-name med of a mix of two meds: amphetamine & dextroamphetamine. It is approved by the Food and Drug Administration (FDA) as a remedy for ADHD & narcolepsy. As a Schedule II controlled substance, this remedy is considered to have a high potential for abuse & can lead to the development of physical dependence.

However, what about modafinil? Is it approved for the therapy of ADHD, just like Adderall? Is it safe and effective for patients suffering from this condition? Continue reading to find out more.

Approval of Modafinil for ADHD

Modafinil, marketed under the brand name Provigil®, is a eugeroic approved by the FDA in 1998 to treat excessive sleepiness related to shift work sleep disorder (SWSD), obstructive sleep apnea (OSA), and narcolepsy. This medicine is also often prescribed to treat daytime sleepiness in Parkinson’s disease, ADHD, & even fatigue that occurs in patients with clinical depression. However, modafinil is not approved for the treatment of the mentioned conditions, including ADHD. It’s known that an application to market the drug for ADHD in children was submitted to the FDA, but approval was denied.

Cephalon (acquired by Teva Pharmaceuticals), a maker of Provigil®, was hoping to expand modafinil usage into the much larger market for ADHD meds. Nonetheless, the FDA advisory committee decided not to recommend approval of this med for children with ADHD. The main reason for this was that an FDA scientist reported children who developed severe skin rashes (Stevens-Johnson syndrome) after using modafinil.

In 2006, Cephalon dropped Sparlon (containing modafinil as its active ingredient) for ADHD after the FDA said no to new drugs for this condition. The company received a non-approvable letter from the FDA on the remedy for ADHD. This is the core reason why the medication isn’t widely prescribed for ADHD in the US. Nonetheless, many ADHD physicians continue to use modafinil in selected patients without problems.

Despite being non-approved, modafinil, when titrated to effect with a target dose of 340 mg for patients with the bodyweight of <30 kg or 425 mg for those with the bodyweight of ≥30 kg is extremely effective in managing the symptoms of & the problem behaviors associated with ADHD in children & adolescents. The remedy is generally well-tolerated, with adverse events (such as headache, weight loss, insomnia, loss of appetite, & gastrointestinal discomfort) generally being mild to moderate (& rarely leading to med discontinuation).

Where to Buy Modafinil for ADHD?

Besides a brand-name version, there exist various generic modafinil drugs produced by certified Indian pharmaceutical companies. It’s paramount to contemplate that generic modafinil and branded Provigil® are equipotent, but the former has one advantage: it is 90%+ cheaper than the original version. Due to this, you don’t have to waste money on the brand-name product – get a generic one with the same active ingredient.

Big manufacturers such as HAB Pharma & Sun Pharma produce the most popular generic modafinil meds. Modvigil is one such product that is made by HAB Pharma. Other generic modafinil bestsellers include Modalert & Provake by Sun Pharma and Modafil MD by Intas Pharmaceuticals.

If considering using modafinil for ADHD, you may opt to buy Modvigil 200 mg tablets over the Internet. Reliable online vendors such as BuyModafinilOnline (BMO) sell this product at a more affordable price than local pharmacies and don’t require a prescription for it. However, note that letting a physician examine your health first to determine if this med is right for you is highly recommended.

References:

  1. Drug Scheduling. Retrieved: March 15, 2021. Dea.gov.
  2. Adderall vs. Modafinil: How Do They Compare? By Editorial Staff. Updated: July 19, 2019. Retrieved: March 15, 2021. Americanaddictioncenters.org.
  3. FDA Committee Rejects ADHD use for Modafinil. By Jon Hamilton. Published: March 24, 2006. Npr.org.
  4. Pediatric Attention Deficit Hyperactivity Disorder (ADHD) Medication. By Maggie A. Wilkes, MD. Updated: November 20, 2018. Retrieved: March 15, 2021. Emedicine.medscape.com.
  5. A review of modafinil film-coated tablets for attention-deficit/hyperactivity disorder in children and adolescents. By Thomas Rugino. Published: June 2007. Ncbi.nlm.nih.gov.