NeurologyLive® Year in Review 2024: Top Stories in Sleep Disorders

In 2024, the NeurologyLive^® team worked tirelessly to deliver the latest clinical news and data across a wide range of neurology subspecialties. From groundbreaking study results and FDA approvals to insightful conference coverage and expert interviews, the website consistently featured the most relevant updates in the field.

A major area of focus was sleep disorders, a field that continues to see significant advancements. While headline-making news often draws the most attention, smaller stories can also rise to prominence due to their clinical impact, relevance, or broader implications for care. These stories collectively reflect the evolving themes and challenges in this specialty over the past year.

Here, we spotlight some of the most-read NeurologyLive® content from 2024. Click below to dive deeper into each story.

1. FDA Approves Avadel's Sodium Oxybate for Cataplexy or Excessive Daytime Sleepiness in Pedatric Narcolepsy

The FDA approved Avadel Pharamaceuticals' supplemental new drug application (sNDA) for sodium oxybate (Lumryz) for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. With this approval, sodium oxybate could reduce the burden on families and caregivers of pediatric patients with narcolepsy who must wake up at night to administer a second dose.

2. Axsome to File NDA Following Positive Phase 3 Results of AXS-12 in Narcolepsy

New findings from the phase 3 ENCORE trial revealed that treatment with AXS-12 (Axsome Therapeutics), an investigational agent for narcolepsy, achieved its primary end point in reducing the number of cataplexy attacks compared with placebo. Coupled with other benefits in excessive daytime sleepiness, cognition, and work productivity, Axsome plans to move towards a new drug application (NDA) filing for AXS-12 and intends to request a pre-NDA meeting with the FDA.

3. FDA Approves Pitolisant for Excessive Daytime Sleepiness in Pediatric Narcolepsy

Months after being granted priority review designation by the FDA, the agency granted approval to Harmony Biosciences' pitolisant (Wakix), a selective histamine H3 receptor inverse agonist, for the treatment of excessive daytime sleepiness (EDS) in pediatric patients aged 6 years and older with narcolepsy.¹ In addition, the agency issued pitolisant a complete response for the treatment of cataplexy in pediatric patients with narcolepsy.

4. Deep Learning Model Predicts Cognitive Status With High Accuracy From Sleep EEG Data

In a new study, a deep learning, multi-task framework using whole-night sleep electroencephalography (EEG) outperformed a comparison model in predicting cognitive status. According to study investigators, this was the first successful deep learning model for jointly predicting cognitive status based on 2 different testing instruments from a patient’s sleep EEG data.

5. Nocturnal Hypoxia and Sleep Apnea Associated With Late-Onset Epilepsy

A new study funded by the National Institutes of Health (NIH) demonstrated that sleep apnea and low oxygen levels during sleep were associated with late-onset epilepsy, independent of hypertension and other comorbidities. Published in Sleep, these findings may help clinicians to better understand the relationship between sleep disorders and late-onset epilepsy as well as assist them with identifying potential treatment targets for this patient population.

6. SynAIRgy Phase 3 Trial Aims to Assess Pharmacological Activation of Upper Airway Muscles to Treat Obstructive Sleep Apnea

At the 2024 SLEEP Annual Meeting, held June 1-5, in Houston, Texas, investigators presented an outline of the phase 3 SynAIRgy trial (NCT05813275), a randomized, controlled study evaluating the efficacy and safety of AD109 (Apnimed), a combination of antimuscarinic aroxybutynin and atomoxetine, as a potential treatment for obstructive sleep apnea (OSA). AD109, a first-in-class once-daily medication, aims to be the first oral pharmacologic therapy that targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep.

7. KP1077 Shows Promise as Potential Treatment for Idiopathic Insomnia in Phase 2 Trial

Data from a phase 2, double-blind, placebo-controlled, randomized-withdrawal, dose-optimizing trial (NCT05668754) showed that KP1077 (Zevra Therapeutics), an investigational agent, was well tolerated in patients with idiopathic hypersomnia (IH), with meaningful improvements in efficacy outcomes. The company previously announced that the results of the secondary efficacy end points were supportive of initiating a phase 3 trial of KP1077.

8. FDA Issues Complete Response Letter for Vanda Pharmaceuticals' Tasimelteon for Insomnia

In July 2023, the FDA assigned a PDUFA date of March 4, 2024, to make a decision on tasimelteon for insomnia, characterized by difficulties with sleep initiation. A month prior, on February 4, 2024, the FDA identified deficiencies regarding labeling and post-marketing requirements. As a result of these deficiencies, the FDA issued a Complete Response Letter (CRL) stating the submission of tasimelteon could not be approved in the treatment's current form.

9. Narcolepsy Agent TAK-861 Moves to Phase 3 Studies Following Positive Phase 2b Data

TAK-861, an investigational oral orexin receptor 2 agonist, performed well in a phase 2b trial (NCT05687903) of patients with narcolepsy type 1 (NT1). Based on these results, and in consultation with global health authorities, the company plans to initiate multiple phase 3 trials of the therapy in NT1 rapidly in the first half of its fiscal year 2024.

10. Light Therapy Improves Sleep and Psychobehavioral Symptoms in Alzheimer Disease

In a recently published meta-analysis of 15 randomized controlled trials (RCTs), results showed that light therapy has significant beneficial effects for patients with Alzheimer disease (AD), demonstrated by improvements in sleep and psychobehavioral symptoms.