How to Get a Prescription for a Custom FDA-Approved Mouth Guard for Sleep Apnea

• A mouth guard for sleep apnea is a custom oral appliance designed to improve airflow while you sleep
• Prescription mouthpieces are different from store-bought “boil-and-bite” guards
• You’ll need a sleep test and a doctor’s diagnosis before you can get a prescription
• Many people can complete testing, diagnosis, and treatment at home with Daybreak

A custom sleep apnea mouth guard is a prescription oral appliance designed to treat obstructive sleep apnea and help reduce snoring. Many of these devices fall under oral appliance therapy and are often classified as mandibular advancement devices (MADs).

Here’s what that means in simple terms:

• What it is: A custom-fit mouthpiece you wear while you sleep
• How it works: It gently shifts your lower jaw forward
• Why that matters: This helps keep your airway open, so breathing stays more stable

How it fits and functions

• Fits over your upper and lower teeth
• Moves the lower jaw forward slightly
• Helps reduce breathing interruptions during sleep

Prescription vs. store-bought mouthguards

Prescription mouthpieces are not the same as over-the-counter options. For example:

• Over-the-counter “boil-and-bite” products may work as an anti snoring mouthpiece, but they aren’t designed to treat sleep apnea
• Prescription oral appliances are custom-fit and clinically monitored to treat a medical condition safely

If you’re wondering why you can’t just buy the best mouthguard for sleep apnea online and call it a day, the answer is simple: sleep apnea is a medical condition, and treating it safely starts with a confirmed diagnosis. A prescription helps ensure you’re getting the right treatment for the right problem—especially since conditions like central sleep apnea have different causes and may require different approaches than obstructive sleep apnea.

Why You Need a Prescription

A prescription also helps make sure:

• You actually have sleep apnea (and not another sleep-related issue)
• The device is safe for your jaw, teeth, and bite alignment
• The treatment fits your anatomy and sleep apnea severity
• You receive a custom-fit device that can be adjusted for comfort and effectiveness over time

Who Can Prescribe a Sleep Apnea Mouthpiece?

A licensed medical doctor diagnoses obstructive sleep apnea using a sleep study and determines whether an oral appliance is appropriate.

To receive a prescription, you’ll need a valid sleep study, such as:

• An in-lab sleep study, or
• An at-home sleep test

If you’ve been reading mouthpiece for sleep apnea reviews, you may have noticed that many people skip the most important part: How do you actually get one? Here’s what the prescription process typically looks like, broken down into simple steps.

1. Complete a Sleep Apnea Assessment

Many people start with symptoms like:

• Loud snoring
• Waking up gasping or choking
• Morning headaches
• Daytime fatigue
• Trouble focusing

A short screening assessment can help you understand whether your symptoms align with common signs of sleep apnea.

2. Take a Sleep Test

A sleep test measures what happens to your breathing while you sleep, including:

• Breathing patterns
• Oxygen levels
• Apnea events (pauses in breathing)

You can complete testing in a sleep clinic, but many people prefer an at-home option for added convenience and comfort.

3. A Doctor Reviews Your Results

After your test, a licensed physician reviews your data and determines whether you have obstructive sleep apnea. Your results also help identify severity, often using the Apnea-Hypopnea Index (AHI), which measures the number of breathing interruptions per hour.

4. Receive a Prescription

If an oral appliance is appropriate for your condition, a doctor can issue a prescription for a custom device. This prescription authorizes the creation of a medical-grade mouthpiece to safely treat sleep apnea.

5. Receive Your Custom Device

Once prescribed, your custom mouthpiece is created using dental impressions or scans to ensure a secure, comfortable fit. You’ll wear the device nightly, and your provider may make adjustments over time to improve comfort and effectiveness.

Thinking about a prescription mouthpiece? Take Daybreak’s at-home sleep test and get diagnosed from home.

Many patients worry about cost—and that’s completely understandable. The good news is that health insurance (not dental insurance) often helps cover prescription oral appliances used to treat obstructive sleep apnea.

Coverage varies by plan, but it may depend on factors such as:

• A confirmed sleep apnea diagnosis
• Severity level (mild, moderate, or severe)
• Whether the device is custom and medically necessary
• Required documentation, including a prescription

In some cases—especially for severe sleep apnea—insurers may require proof that CPAP wasn’t tolerated before approving coverage for an oral appliance. That’s why working with a provider who can help you navigate insurance requirements can make the process feel much less stressful.

Both CPAP therapy and prescription oral appliances are clinically valid treatments for sleep apnea. The best option depends on your diagnosis, anatomy, and what you can realistically use consistently over time.

Many patients prefer oral appliances because they don’t require a machine or mask. For some people, a custom device may also feel more manageable than using an anti snoring device that isn’t designed for sleep apnea treatment.

Daybreak makes it easier to get diagnosed and treated for sleep apnea—without the hassle of traditional sleep clinics. The process is designed to be comfortable, convenient, and fully doctor-directed, so you can move forward with confidence.

With Daybreak, many patients can complete the prescription process from home, including:

• At-home sleep testing reviewed by licensed physicians
• A doctor-directed diagnosis and treatment plan
• A custom FDA-cleared oral appliance for eligible patients
• Insurance support to help lower out-of-pocket costs

No sleep clinic visits, no long wait times, and no unnecessary runaround—just a streamlined path to CPAP-free treatment.

Sleep apnea usually doesn’t resolve on its own—but the good news is that it’s highly treatable. With a confirmed diagnosis and a treatment plan that fits your lifestyle, many people see real improvements in sleep quality, energy, and day-to-day well-being.

If you’re ready to explore a CPAP-free option, start with the easiest first step: Take Daybreak’s 30-second assessment to see if a prescription mouthpiece could be right for you.

1. Do you need a prescription for a sleep apnea mouthpiece?

Yes. If the mouthpiece is intended to treat obstructive sleep apnea, you’ll typically need a prescription based on a confirmed diagnosis.

2. Can a dentist prescribe a sleep apnea mouthpiece?

A dentist may help create and fit the device, but a licensed medical provider must diagnose sleep apnea and prescribe the treatment.

3. Are sleep apnea mouthpieces FDA-approved?

Many prescription oral appliances are FDA-cleared medical devices, meaning they meet established safety and effectiveness standards when used as intended.

4. Can I get diagnosed and receive a prescription at home?

In many cases, yes. At-home sleep testing and telehealth review can allow you to complete much of the process remotely.