Here at The Pure Sleep Company, we strive to make the purchase, fitting and nightly experience as easy as possible for our customers. If you don’t see the information you are looking for, please submit your question(s) through our online Support, and we’ll get back to you with an answer shortly!
For general questions about purchasing, fitting and the ongoing use of your PureSleep device, consult our list of FAQs.
You can read more detailed clinical information about the safety and efficacy of MRDs as a treatment for snoring.
Frequently Asked Questions
How does the PureSleep® device work?
PureSleep works by a technique called ‘mandibular repositioning’ whereby the device gently holds your lower jaw forward, which creates an open airway through your throat, eliminating the vibrations that cause snoring. There is significant clinical research supporting the use of this technique.
Is it safe?
Mandibular repositioning to reduce snoring has been safely prescribed by dentists and physicians for over a decade, and the PureSleep device has a remarkable record of safe and effective use. In fact, PureSleep has been used by thousands of snorers without a single FDA reportable adverse event. As with all medical products, you should carefully read and follow all instructions and labeling before use to ensure that PureSleep works safely and effectively. See how PureSleep works.
Why does PureSleep require a prescription?
PureSleep is a Class II medical device which thereby requires a prescription from a licensed dentist or physician. The patented PureSleep device has been cleared by the FDA for sale exclusively by The Pure Sleep Company and PureSleep Partner physicians and dentists
Why do I need to answer this long phone or web questionnaire in order to get PureSleep?
PureSleep is a Class II medical device and thereby requires a prescription from a licensed dentist or physician. Our questionnaire guides you through a set of questions one would get from their doctor and ensures that you do not have any other conditions that might compromise the safety and effectiveness of the PureSleep device.
How difficult is it to fit the device?
Fitting PureSleep is quick and easy. All you do is immerse the device in boiling water and mold it to the shape of your mouth. We include a step-by-step Instruction Guide in your PureSleep kit, and we highly suggest you read this in detail before doing the fitting.
Is PureSleep adjustable?
Yes, PureSleep is adjustable. There are 3 settings that loosen or tighten the device. You select the setting when you are initially fitting the device, however once molded that setting cannot be changed for the life of the product.
Does it hurt? Is it difficult to get used to the product?
Typically, the adjustment period takes about 3-5 nights of consistent use. It is perfectly normal for your jaw, teeth and gums to feel moderately sore and fatigued at first. This discomfort is much like getting braces or a retainer for the first time. However, it is not normal to experience severe, sharp or ongoing pain. These symptoms may be an indication of a more serious problem with your jaw called temporomandibular disorder (TMD). If you experience these symptoms or believe you have TMD, discontinue use immediately, contact your dentist or physician, and return your PureSleep device for a full refund.
What if it doesn’t work for me? Can I return it?
Absolutely. But we know you didn’t buy it just to return it, so please give us a chance to help you with the adjustment and fitting process by calling our PureSleep Helpline at 1-866-879-3777. And if within 30 days you need to return or replace the unit due to a mis-fitting, we are happy to make the exchange or refund your money in full.
How often should I replace my PureSleep device?
Each PureSleep device undergoes normal wear and tear through the course of wearing it every night. We recommend replacing the unit every 6-9 months. Some individuals grind their teeth more than others and therefore may need to replace the unit more often. It is possible to re-boil it up to 3-4 times if it needs to be reshaped.
I have a spouse who snores, and I’d love to give PureSleep as a gift. Is there a way to do that?
Yes, PureSleep makes a great gift for loved ones who snore. It’s easy to give PureSleep as a gift – simply call us at 1-800-283-2667 to purchase a gift credit. Your loved one can then call us, present their gift code and take the phone-based prescription questionnaire, and the device will be sent to them. And if for any reason we are unable to prescribe PureSleep for them, we will refund your money in full.
How does PureSleep differ from the athletic mouthguards I see at my local sports store?
Though it may look similar, the PureSleep device is significantly different from an athletic mouthguard. PureSleep is an adjustable device designed to hold your lower jaw forward, thus opening up your airway while you sleep. Unlike athletic mouthguards, our patented device is made from two different high-quality plastics, both a hard plastic on the outside and a soft plastic on the inside, which gives it more structural rigidity, making it less bulky and therefore more comfortable since there’s less material overall. Our device is manufactured here in the USA with only American-sourced materials. Finally, an athletic mouthguard is only designed to protect your teeth and mouth from injury; it is not designed to hold your jaw in a specific position.
How does PureSleep differ from other MRDs?
There are several key differences between PureSleep and other MRDs. First and foremost, PureSleep is adjustable via three settings that are selected when the initial fitting is done whereas most competitor products have only one setting. Secondly, unlike other MRDs and athletic mouthguards, our patented design includes two different kinds of high-quality plastic; a hard plastic on the outside and a soft plastic on the inside which gives it more structural rigidity makes it less bulky and therefore more comfortable since there’s less material overall. Finally, PureSleep is manufactured here in the USA with only American-sourced materials unlike many competitor products which are manufactured overseas.
How long does it take to get my product after I’ve ordered?
Orders received online shipped to customers in the continental US will generally arrive in 2-weeks via standard shipping and 1-week rush shipping. Orders received over the phone take slightly longer to process and therefore generally arrive within 3-4 weeks standard shipping and 1-2 weeks rush shipping. We do ship to a select list of countries outside the US including Canada. All International orders outside Canada are shipped “air mail” and subject to the local duties and customs clearance procedures of each country.
Can PureSleep be used to treat obstructive sleep apnea (OSA)?
No, PureSleep is intended only for the reduction of snoring. It is not intended to treat sleep apnea or any other medical condition.
Can I buy PureSleep through my dentist?
Yes, any licensed dentist or physician in the US or Canada can prescribe PureSleep for you through our Dental and Medical Partner program. If you are a medical or dental professional, we invite you to apply for the Puresleep Partner program.
Clinical studies show that mandibular repositioning devices (MRDs) work well as a treatment for snoring. There are a variety of other treatments available, but we believe MRDs are the most effective treatment for snoring and here’s why…
Surgery works but it’s extremely expensive, there are risks, and snoring can reoccur after a couple of years.1 Nasal dilators, like nose strips, may help a small percentage of snorers because the shape of their nostrils is too narrow, thereby restricting nasal airflow, but that’s not the typical reason most people snore. Special pillows can provide modest relief, but mainly because they encourage people to sleep on their sides instead of their backs, where snoring is normally worse. Aside from this benefit, they offer little, if any relief. Throat lubricants (which are typically sprays) have been proven not to work. 2
Go To Article
“Oral appliances for the treatment of snoring and obstructive sleep apnea,” S.R. Schoem, Connecticut Children’s Medical Center Dept. of Otolaryngology, Hartford, CT, Otolaryngology – Head and Neck Surgery, February, 2000.
Go To Article
“Oral appliances in the treatment of obstructive sleep apnea and snoring,” E.T. Ayas and L.J. Epstein, West Roxbury Veterans Affairs Medical Center, Pulmonary Division, Roxbury, MA, Current Opinions in Pulmonary Medicine, November, 1998.
Go To Article
“State-of-the-art in the treatment of snoring and sleep apnea” (translated from Dutch), H.J. Remmelink, Ned Tijdschr Tandheelkd, January, 2003.
Go To Article
“Ten-year follow-up of mandibular advancement devices for the management of snoring and sleep apnea,” Jauhar, Lyons , Banham, Cameron, and Orchardson; Department of Restorative Dentistry, Glasgow Dental Hospital, Glasgow, UK, Prosthetic Dentistry, April, 2008.
Go To Article
“Principles of mandibular advancement device applied to the therapeutic of snoring and sleep apnea syndrome,” Petitjean, Chammas, Langevin, Philit, and Robert, Laboratoire des Troubles Respiratoires liés au Sommeil, Hôpital de la Croix-Rousse, Lyon, France, Sleep, June, 2000.
Go To Article
"Oral appliances in the treatment of obstructive apnea and snoring,” Veterans Affairs Medical Center, Roxbury MA, Current Opinions in Pulmonary Medicine, November 1998.
Go To Article
“Mandibular advancement devices for the control of snoring,” Churchill Hospital, Oxford UK. European Respiratory Journal, 1998.
Go To Article
- 1 Laryngoscope. 2009 August; 119 (8):1617-20. “Radiofrequency-assisted uvvlopalatoplasty for snoring: Long-term follow-up.” Stuck BA.; Ear, Nose & Throat Journal, Nov 1999. “Snoring surgery: Which one is best for you?”, Philip D. Littlefield, Eric A. Mair
- 2 Otolaryngology Head Neck Surgery. 2004 Jun;130(6):649-58, Popular snore aids: do they work?, Michaelson PG, Mair EA., Department of Otolaryngology-Head and Neck Surgery, Wilford Hall USAF Medical Center, San Antonio, TX 78236, USA.