The US Food and Drug Administration cleared and approved these products in the sleep medicine space between January 1 and October 13, 2014. Products likely to be cleared or approved (per the manufacturer’s guidance) between October 11, 2015 and April 30, 2015 are described in the pipeline section.

Inspire Therapy Inspire Upper Airway Stimulation is for people with moderate to severe obstructive sleep apnea who are unable to use CPAP. The fully implanted system senses breathing patterns and delivers mild stimulation to key muscles, keeping the airway open during sleep. Hetlioz Hetlioz (tasimelteon) 20 mg capsules treat Non-24-Hour Sleep-Wake Disorder, a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. Non-24 affects the majority of totally blind individuals. Belsomra A prescription pharmaceutical for adults with insomnia who have difficulty falling asleep and/or staying asleep, Belsomra is a highly selective antagonist for orexin receptors. ResMedAirSense Autoset ResMed’s AirSense 10 AutoSet for Her uses a clinically proven algorithm to provide specialized sleep apnea therapy for women based upon specific female breathing patterns. ResMed AirSense 10 ELITE AirSense 10 Elite is ResMed’s step-up CPAP device that includes detection of central sleep apneas and Cheyne-Stokes respiration. ResMed AirSense 10 AutoSet ResMed’s AirSense 10 AutoSet devices continually monitor breathing, adapting breath by breath to always deliver the lowest therapeutic pressure, improving comfort and sleep. ResMed AirSense 10 CPAP ResMed’s AirSense 10 CPAP includes advanced features that are standard with AirSense 10 series devices, such as connected care, remote device settings changes and trouble-shooting, HumidAir heated humidification, AutoRamp, and simple, elegant user-friendly controls for patient confidence. 3BBPAP 25A 3B’s BPAP 25A is a full featured auto bilevel device that comes standard with advanced features like RESlex Exhalation Relief, a full range of pressure support, and advanced clinical settings, and integrates into 3B’s management system iCodeConnect. WinxMouthpiece The next generation Winx Mouthpiece features a softer, more flexible posterior bar that sits over the back of the tongue and is designed for improved patient comfort. NightShift Night Shift is a therapy for positional obstructive sleep apnea. Worn on the back of the neck, it vibrates when users begin to sleep on their back and slowly increases in intensity until a position change occurs. Night Shift is also an intelligent, interactive monitor that allows users to track its effect on snoring and sleep quality.


The CAD/CAM milled MicrO2 device offers dentists a new option for obstructive sleep apnea patients. Featuring a precision milling production process, the device uses a PMMA material cured under controlled conditions, allowing the MicrO2 to be small, strong, precise, and predictable.


Theravent is an over-the-counter treatment used to reduce or eliminate snoring using Expiratory Positive Airway Pressure (EPAP) therapy, a technology also contained in the company’s prescription sleep apnea treatment, Provent. Theravent LITE generates approximately 1/10th the pressure of Provent, and Theravent Max generates approximately half the resistance of Provent.



The Perfect Fit II R/S Effort System is designed as an alternative for Embla PSG systems that have RIP circuitry built into the electrode input module. It comes in both reusable and disposable belt options. SomnomedFUSION The SomnoDent Fusion (available in Classic and Flex options) oral appliance for obstructive sleep apnea has exchangeable wings, which makes adjustments of the forward position of the SomnoDent device easier for the practitioner and patient.


Relaxis provides physical nonpharmacological relief of restless legs syndrome (RLS) while enabling the patient to remain in bed. During an RLS episode, the patient places the pad at the site, and the device provides 30 minutes of vibratory counterstimulation, gradually ramping down and shutting off.


WatchPAT Unified, the newest version of the home sleep diagnostic device that provides both sleep apnea and sleep stages information, now allows the test to be performed using a single finger only to collect both oximetry and PAT signal data in a Unified finger sensor.


The Nellcor Portable SpO2 Patient Monitoring System (PM10N) is a portable oximeter that is equipped with home care and sleep study modes and complies with IEC 60601-1-11 standards for devices used in the home healthcare environment.

In the Pipeline

Sleep Profiler software is being adapted to run in real time on a tablet, allowing clinicians to monitor sleep architecture and continuity in the ICU continuously for as many as 24 hours.

Makers of the travel-friendly Z1 CPAP, Human Design Medical will be debuting an APAP version of the sleep apnea therapy device.

The Nastent by Seven Dreamers Laboratories Inc is a tube-shaped nasal cavity insertion device that aids breathing by preventing the obstruction of the airway.