NeurologyLive® Year in Review 2023: Top Stories in Sleep Disorders

In 2023, the NeurologyLive^® staff was a busy bunch, covering clinical news and data readouts from around the world across a number of key neurology subspecialty areas. From major study publications and FDA decisions to societal conference sessions and expert interviews, the team spent all year bringing the latest information to the website's front page.

Among our key focus areas is sleep disorders. Sleep medicine specialists experienced a number of FDA decisions in the past 12 months, among other progress in the existing knowledge of sleep pathology. Although major news items often appear among the top pieces our team produces, sometimes smaller stories reach those heights for other reasons—clinical impact and interest, or concerns about the small- or big-picture parts of care, for example. Whatever the reason for the attention these stories got, their place here helps provide an understanding of the themes in this field over the course of 2023.

Here, we'll highlight some of the most-read content on NeurologyLive^® this year. Click the buttons to read further into these stories.

1. FDA Clears Vivos CARE Appliance for Severe Obstructive Sleep Apnea

The FDA granted 510(k) clearance to Vivos Therapeutics for its removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances as a treatment option for patients with severe cases of obstructive sleep apnea (OSA). The newly approved devices, which include the flagship DNA (Daytime-Nighttime Appliance) oral appliance, the mRNA oral appliance, and the mmRNA oral appliance, give patients a new alternative to continuous positive airway pressure (CPAP) or surgical neurostimulation.

2. FDA Clears Neurovalens’ Modius Sleep Device for Insomnia

According to an announcement from Neurovalens, the FDA granted 510(k) clearance for its Modius Sleep device as a new treatment for patients with chronic insomnia. The company is now planning to enter discussions with insurance providers to achieve reimbursement status so patients can access the treatment through their medical insurance.

3. FDA Approves HoneyNaps’ Artificial Intelligence Sleep Disorder Diagnosis Software

The FDA approved HoneyNaps’ SOMNUM artificial intelligence (AI) sleep disease analysis algorithm, the first AI solution designed for diagnosing sleep disorders. SOMNUM, supported by eXplainable Medical AI technology, utilizes deep learning-based AI to conduct a real-time analysis of vast volumes of multi-channel/time series biosignals.

4. SomnoRing Appears Usable and Acceptable to Assess Sleep Health in Diverse Populations

In a recent study published in JMIR Formative Research, findings from a 7-night experiment among a group of racially, ethnically, and socioeconomically diverse patients with sleep disorders perceived the SomnoRing (Somnology) as useful for tracking sleep and more comfortable compared with other wearable sleep devices. These findings suggest the potential for wearables like SomnoRing to improve sleep health among marginalized patient populations.

5. FDA Approves Once-Nightly Formulation of Sodium Oxybate to Treat Narcolepsy

After recently submitting an amendment to the FDA’s request for final approval, Avadel Pharmaceuticals announced the agency officially approved its oral, extended-release formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. Marketed as Lumryz, it becomes the first and only FDA-approved once-nightly oxybate for patients with the condition.

6. EMA Approves Pitolisant for Pediatric Narcolepsy

The European Medicines Agency (EMA) granted approval for the marketing authorization for pitolisant (Wakix, Harmony Biosciences) for the treatment of narcolepsy in pediatric patients age 6 years or older, with or without cataplexy. Pitolisant is the first and only drug in the class of antagonist/reverse agonists of the histamine H3 receptor for the treatment of narcolepsy.

7. Mazindol Extended Release Agent Demonstrates Significant Efficacy in Open-Label Extension in Narcolepsy

In newly announced, long-term findings from an open-label extension study (OLE), NLS Pharmaceuticals’ lead product candidate, Quilience, an extended-release formulation of mazindol, showed improvement in patients with narcolepsy who remained on treatment through the double-blind phase and among those who crossed over from placebo.

8. Driving Performance in Patients With Narcolepsy Improved Through Solriamfetol

Recently published data from a randomized, placebo-controlled, crossover study (NCT02806908) showed that treatment with solriamfetol (Sunosi; Jazz Pharmaceuticals) at 150 mg/day for 3 days followed by 300 mg/day for 4 days significantly improved driving performance in patients with narcolepsy.

9. Pitolisant Improves Pediatric Narcolepsy Symptoms Regardless of Cataplexy in Phase 3 Study

Findings from a newly published phase 3 trial (NCT02611687) demonstrated significant reductions in excessive daytime sleepiness (EDS) and cataplexy in pediatric patients aged 6 to 17 years with narcolepsy treated with 5 mg to 40 mg a day of pitolisant. These findings suggest that pitolisant, a selective histamine H3 receptor inverse agonist, is a safe and effective treatment for children and adolescents with narcolepsy

10. Opioids Improve Disturbed Nocturnal Sleep and Excessive Daytime Sleepiness in Narcolepsy Type 1

In a recent systematic literature review and questionnaire study published in Sleep Medicine, findings showed that opioids, specifically oxycodone and codeine, were associated with improvements in self-reported narcolepsy symptoms such as disturbed nocturnal sleep and excessive daytime sleepiness. Overall, these findings suggest that opioid use could provide symptom relief in patients with narcolepsy type 1.