Alpha-Stim FAQs
*FDA cleared for anxiety, insomnia and pain only, with approval for depression outside of the United States.
Facts About Using Alpha-Stim for Anxiety, Insomnia, Depression, and Pain
What does Alpha-Stim treat?
Alpha-Stim is a prescription medical device that is FDA cleared for anxiety, insomnia and pain only, with approval for depression outside of the United States. While prescription is required in the US, it is available over-the-counter in other countries.
Alpha-Stim AID is a cranial electrical therapy device for treating anxiety, insomnia, and depression.
Alpha-Stim M is specifically designed as a drug-free pain relief treatment option for acute pain, post-traumatic pain, and chronic pain, along with treating anxiety, insomnia, and depression.
What kinds of pain does Alpha-Stim relieve?
Alpha-Stim M can help relieve all types of acute pain, chronic pain, and post-traumatic pain. Get more information here.
How long will I have to use Alpha-Stim?
Alpha-Stim effectively treats your anxiety, insomnia, depression, and pain. For some conditions, results are experienced immediately and for others a small amount of time and persistence provides needed relief and results. Learn more about how long to use Alpha-Stim and when to decrease usage here.
Is Alpha-Stim safe to use?
Yes. In over 40 years of clinical studies involving over 8,800 people, only minor side effects such as headaches and skin irritation at electrode sites have been reported by a tiny fraction of users. You can view all risk information here.
Can Alpha-Stim treat pain and anxiety at the same time?
We recommend treating your pain first, followed by cranial electrical stimulation treatment for anxiety, and/or insomnia. Alpha-Stim is uniquely designed to be used for anxiety, insomnia, depression, and pain. Learn more here.
How effective is Alpha-Stim for treating anxiety and insomnia?
Nine out of 10 patients report significant improvements in these conditions. You can view clinical research and data here.
Will I have to stop taking my medications when using Alpha-Stim?
There has been no evidence of drug interaction in 40 years of research and use of Alpha-Stim. Medication change is a decision that should be discussed with your healthcare practitioner.
Is Alpha-Stim approved to treat all mental health conditions?
Alpha-Stim is FDA cleared for anxiety, insomnia and pain only, with approval for depression outside of the United States.
Getting Alpha-Stim
Does my doctor need to prescribe Alpha-Stim? [Is a prescription required for Alpha-Stim?
In the United States, a licensed healthcare practitioner needs to write a prescription for the device to be purchased. If you do not have a doctor or would like to consult with a telehealth group, click here.
Learn more about getting Alpha-Stim in the United States here.
For the rest of the world (outside of the USA), Alpha-Stim is available over the counter.
How can I get Alpha-Stim M or Alpha-Stim AID for patients?
Typically trying Alpha-Stim in the office or clinic can identify those individuals who readily respond to Alpha-Stim treatment. You or your patients can fulfill your order in 3 easy ways:
- Shop our online store
- Call 1-800-367-7246
- Fax a retail order form
Is there special pricing for practitioners?
Special pricing options for practitioners may be available. For practitioner volume discount pricing, call us at 1-800-367-7246 (in USA), + (940) 328-0788 (outside USA), or email us at info@epii.com.
How much do Alpha-Stim M and Alpha-Stim AID cost?
The Alpha-Stim M device, which treats pain, anxiety, insomnia, and depression, costs $1,363.
The Alpha-Stim AID device, which treats anxiety, insomnia, and depression, costs $882.
Alpha-Stim comes with a 30-day money back satisfaction guarantee, a 5-year limited warranty, and accessory costs are minimal.
Is Alpha-Stim more expensive than other treatments for anxiety, insomnia, depression or pain?
Over 5 years, someone who takes medication – such as pain pills, antidepressants and sleep aids – or does other treatments typically used to treat pain, anxiety and insomnia can pay thousands of dollars more than someone using Alpha-Stim.
Will my health insurance cover Alpha-Stim?
Insurance coverage varies by policy. Durable medical equipment coverage is often required to obtain some level of reimbursement for Alpha-Stim devices. EPI does not bill private carriers but will assist customers by providing a paid invoice and a sample Statement of Medical Necessity for your practitioner to complete. This statement is typically required by the insurance carrier if the device is covered.
The HCPCS code for the Alpha-Stim AID is E0732 and the Alpha-Stim M is E1399.
If you have a flex spending account (FSA) or health savings account (HSA), you may use these to purchase an Alpha-Stim.
Comparing Alpha-Stim to Vagus Nerve Stimulators
Is Alpha-Stim a VNS device?
No. Alpha-Stim is a CES device. Due to the similarity in using an electrical current or earclip electrode application, Alpha-Stim can commonly be misidentified as a VNS device or auricular vagus nerve stimulation (aVNS) devices. And while Alpha-Stim does interact with the vagus nerve, there are key differences in the types of stimulation Alpha-Stim utilizes and the brain regions it targets.
Does Alpha-Stim Stimulate the Vagus Nerve?
Yes.
Alpha-Stim isn’t specifically designed to target the vagus nerve like dedicated vagus nerve stimulation (VNS) devices. However, its cranial electrotherapy stimulation (CES) does engage neural pathways that include vagal function (the vagus nerve), which may contribute to some of the clinical benefits seen with the device.
To better understand how Alpha-Stim works, Ryan Gober, PhD, the Medical Science Liaison at Electromedical Products International, explains:
“Alpha-Stim uses a low intensity, patented waveform delivered through bilateral earclip electrodes to modulate cortical activity in the temporal lobe of the brain and to stimulate nearby key cranial nerves, including the vagus, trigeminal, and vestibulocochlear nerves that project to deeper subcortical brain structures. Through these two synergistic mechanisms, Alpha-Stim has been shown to modulate activity in the default mode network (DMN), which is widely reported to exhibit altered connectivity in a number of mental health conditions, including anxiety and insomnia.”
Do I need both Alpha-Stim and a VNS device?
The short answer? No. See why below.
VNS devices are designed specifically to target the vagus nerve, whereas Alpha-Stim works in a broader capacity through cranial electrotherapy stimulation (CES) delivered via the earlobes. This approach interacts with vagal pathways along with other cranial nerve networks, which is part of why Alpha-Stim is FDA-cleared for the treatment of anxiety, insomnia, and pain only, with approval for depression outside of the United States.
To better understand how Alpha-Stim works, Ryan Gober, PhD, the Medical Science Liaison at Electromedical Products International, explains:
“Alpha-Stim uses a low intensity, patented waveform delivered through bilateral earclip electrodes to modulate cortical activity in the temporal lobe of the brain and to stimulate nearby key cranial nerves, including the vagus, trigeminal, and vestibulocochlear nerves that project to deeper subcortical brain structures. Through these two synergistic mechanisms, Alpha-Stim has been shown to modulate activity in the default mode network (DMN), which is widely reported to exhibit altered connectivity in a number of mental health conditions, including anxiety and insomnia.”
Does Alpha-Stim interact with the vagus nerve?
Vagus nerve stimulation (VNS) and VNS devices are often promoted for improving mood, emotional regulation, depression, and pain.
Alpha-Stim does interact with the vagus nerve, but there are key differences in the types of stimulation Alpha-Stim utilizes and the brain regions it targets.
- Alpha-Stim delivers its patented cranial electrotherapy stimulation (CES) waveform through small clips on both earlobes. While the stimulation begins at the ear, the resulting electric fields extend beyond the clip sites to influence nearby cranial nerves, including the auricular branch of the vagus nerve.
- What sets Alpha-Stim apart from a VNS device is that its fields don’t stop at the nerves outside the skull; they also pass through the bone to reach cortical layers of the brain. This direct brain engagement allows Alpha-Stim to modulate activity in brain regions such as the temporal lobe and in broader brain networks that are often dysregulated in anxiety and insomnia.
- By influencing both cranial nerves and cortical circuits, Alpha-Stim offers a distinct mechanism that helps normalize signaling in functional networks tied to these conditions.
Is Alpha-Stim better for anxiety than a VNS device?
Regulatory authorization differs across VNS and non-VNS devices. Alpha-Stim is FDA-cleared (Class II) with defined, labeled indications, whereas other non-invasive products are often marketed in the United States solely as general-wellness devices (GWDs) and are not cleared to treat medical conditions. Alpha-Stim CES is cleared for the treatment of anxiety and insomnia, and Alpha-Stim M’s MET technology is cleared for pain management.
In practical terms, FDA clearance means the device has been reviewed in accordance with applicable regulatory requirements for specific medical indications, and the manufacturer has provided supporting evidence—including performance testing and clinical data—demonstrating that the device meets FDA expectations for safety, performance, and labeling. In contrast, general wellness products are not reviewed or cleared by the FDA for specific medical claims or indications.
Always verify each device’s clearance, labeling, and supporting evidence when choosing a treatment option.
As such, Alpha-Stim offers a unique combination of mechanistic overlap with vagus nerve–targeting devices and the regulatory assurance of FDA clearance for clinical use. (Outside the United States, Alpha-Stim is approved for treating anxiety, insomnia, and pain, as well as depression.)
In conclusion, clinical research suggests Alpha-Stim CES works via a multimodal mechanism involving indirect stimulation of the vagus nerve as well as cortical brain regions that have been linked to anxiety and insomnia.
Moreover, Alpha-Stim is evidence-based, with numerous clinical studies supporting FDA clearance to treat symptoms of anxiety and insomnia as reflected in the device’s labeling. This combined stimulation of cranial nerves and cortical brain regions, along with differences in regulatory authorization, distinguishes Alpha-Stim from devices focused solely on non-invasive VNS/aVNS.
Using Alpha-Stim FAQs
Are there benefits to using Alpha-Stim as a complement to TMS?
Transcranial Magnetic Stimulation (TMS) primarily treats depression, but for many individuals, depression is not the only mental health issue.
Alpha-Stim may be a practical component of comprehensive care alongside TMS because it is FDA-cleared for anxiety and insomnia, can be used conveniently at home, and is generally well tolerated. By supporting symptom relief beyond depression alone, Alpha-Stim may help improve patient comfort, engagement, and potentially contribute to stronger long-term treatment outcomes.
Can Alpha-Stim help TMS patients with anxiety?
Alpha-Stim can provide Transcranial Magnetic Stimulation (TMS) programs with a unique ability to begin treating patients before TMS by proactively addressing anxiety and insomnia at home.
See below for an outline of how easily Alpha-Stim integrates into the TMS patient journey:
- Pre-TMS: Support patients on waitlists by providing access to at-home neuromodulation solutions to offer relief from anxiety and insomnia symptoms.
- In-clinic: Reduce pre-procedural anxiety to enhance patient comfort prior to undergoing TMS.
- Between TMS Sessions: Management of anxiety and insomnia symptoms outside of the clinic.
- Post-TMS: Strengthen therapeutic alliance with patients post-discharge by offering continued non-pharmacological treatment for anxiety and insomnia.
Should I use Alpha-Stim along with another device, like a VNS device?
If you’re considering stacking Alpha-Stim with another device, pause.
Alpha-Stim is FDA-cleared to treat anxiety, insomnia, and pain, making it a strong primary treatment option. You can use Alpha-Stim along with other treatment modalities, but using it along with a VNS device or other CES device is not necessary.
See why you don’t need a VNS device and Alpha-Stim >
Alpha-Stim is a great option to use to complement TMS though! See why here.
Speak with your healthcare provider before using Alpha-Stim alongside other modalities or treatments. There has been no evidence of drug interaction in 40 years of research and use of Alpha-Stim. Medication change is a decision that should be discussed with your healthcare practitioner.
Does Alpha-Stim help with neuropathy?
Neuropathy refers to damage or dysfunction of peripheral nerves that can result in symptoms such as tingling, burning, numbness, and pain.
While Alpha-Stim is not FDA-cleared to treat the underlying cause of neuropathy, it is FDA-cleared to treat acute, post-traumatic, and chronic pain in adults. This means that although Alpha-Stim does not address the nerve damage itself, it can be used as part of a broader management plan to help reduce the pain associated with neuropathy.
Other Alpha-Stim FAQs
How soon after I order Alpha-Stim will it arrive?
What does Alpha-Stim look like?
The Alpha-Stim M and AID devices are both about the size of a small rectangular cell phone, (but a little thicker).
What do I need to help me get started with Alpha-Stim?
Each Alpha-Stim device comes with everything you need to get started: earclip electrodes and earclip electrode pads (for the Alpha-Stim AID and Alpha-Stim M), AS-Trodes and Smart Probes with probe electrode pads (only included for the the Alpha-Stim M), Alpha-Stim Conducting Solution (to ensure a good electrical connection), two 1.5 volt batteries per device (AA for the M, and AAA for the AID), and a convenient lanyard for you to wear the Alpha-Stim device around your neck.
Each Alpha-Stim also comes with an owner’s manual that explains how to use the device and what kind of relief you can expect from it.
Visit our Resource Center to find online copies of the Alpha-Stim owner’s manuals and watch helpful how-to videos for using Alpha-Stim AID and Alpha-Stim M.
Why is Alpha-Stim “cleared” by the FDA, not “approved”?
All medical device manufacturers who seek to market devices in the United States must register with the FDA through one of two ways—the section 510(k) process, where a device is “cleared” for distribution, or the Pre-Market Approval process, where a device is “approved” by the FDA.
Alpha-Stim has undergone the 510(k) process and is FDA-cleared for the treatment of anxiety and insomnia as well as acute, post-traumatic, and chronic pain.
Is Alpha-Stim the same as other CES devices?
No. Not all CES devices are the same. And this is why researching a device is critical. Below are some things that make Alpha-Stim stand out from other CES devices in the market:
- Alpha-Stim uses a patented waveform, making the stimulation it uses distinct from other CES devices.
- Decades of clinical evidence demonstrates safety and long-term efficacy.
- Alpha-Stim delivers cumulative results that build over time for long-lasting anxiety, insomnia & depression* relief.
- Alpha-Stim stimulates the brain to normalize the pathological signaling in the default mode network that is observed in psychiatric disorders, providing rapid, effective, and lasting symptom relief without the side effects of medication [In simpler terms, Alpha-Stim CES modulates the brain network associated with anxiety, insomnia, and depression to help bring it back to “normal”]
- Alpha-Stim also offers the ability to treat pain. This is another differentiator between other CES devices and Alpha-Stim.