Monarch eTNS®

The Monarch device has received FDA approval for children aged 7 to 12. This approval is specifically for use as a standalone treatment, rather than medication. However, it can also be prescribed off-label for adults with ADHD, just like any other FDA-approved treatment.

It operates by producing an electrical current via adhesive conductive pads affixed to your forehead. You need not increase the intensity significantly; a minimal adjustment is sufficient to induce a mild tingling sensation. The device emits pulses in a precise pattern that, by way of cranial nerve V division 1, restructures your brain networks, thereby improving your capacity to concentrate and maintain attention.

The Monarch device is FDA- approved for kids 7 through 12. The approval is as monotherapy—instead of medication—but it can be prescribed, like all FDA-approved treatments— off-label for adults with ADHD.

The Monarch device is priced at approximately $1,000 plus shipping if not picked up locally. Additional expenses come from refilling the adhesive pads, which cost $250 per month, inclusive of shipping.For children aged 7-12, a significant portion of these expenses can potentially be covered by your insurance or a commercial insurance coupon. The coupon brings the price down to $100 initially and then $40 per month. However, for adults, it is an out-of-pocket expense.

By way of comparison, Mydayis (a triphasic amphetamine medication) carries a list price of around $400 per month.

After four weeks of nightly use, 64% of the study group were rated as “improved” or “improved very much” on the Clinical Global Impression–Improvement (CGI-I) scale. After eight weeks, 71% had achieved that rating. ADHD Rating Scale-IV (ADHD-RS-IV) scores showed a 47% decrease, compliance was 100%, and no child withdrew from the study due to adverse events.

The most common side effects observed with eTNS use include drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue. No serious adverse events have been associated with use of the device.

When considering the question of why the Monarch eTNS® device may be a preferable option to stimulants for the treatment of ADHD, it's important to recognize the advantages it offers.

First and foremost, the Monarch eTNS® device presents a more convenient and streamlined approach to ADHD treatment. In a climate of stimulant shortages and the associated hurdles of dealing with the DEA and supply chain constraints, this brain stimulator provides an effective solution that is readily accessible at scale.

Furthermore, the device is characterized by its safety profile, often classified as "minimal risk." Its use involves wearing a small pad on the head and placing the stimulator nearby, akin to the comfort of using a CPAP device, but tailored to enhancing attention.

The choice of initial treatment holds significant sway, as patients tend to adhere to what proves effective. While stimulant medications can be efficacious, they also entail additional challenges for healthcare providers and impose stress on families. In today's landscape, every stimulant prescription can trigger a subsequent quest to locate a pharmacy with the necessary supply, further complicated by legal constraints on disclosing stock availability due to the fallout from opioid lawsuits.

In light of these considerations, the Monarch eTNS® device emerges as a promising alternative, offering convenience, safety, and accessibility, and potentially alleviating many of the burdens associated with traditional stimulant treatments for ADHD.