Sleep Month in Review: June 2025

In June, sleep medicine updates from SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies in Seattle from June 8 – 11th, highlighted advances in pharmacotherapy and evolving guidelines. AXS-12 showed phase 3 efficacy for narcolepsy, while new obstructive sleep apnea (OSA) treatments—tirzepatide, AD109, and potassium channel blockers—offered personalized options beyond CPAP. Updated restless legs syndrome (RLS) guidelines advised against dopamine agonists due to augmentation risk, favoring iron and alpha-2-delta therapies

Explore HCPLive’s June 2025 sleep medicine recap for the latest clinical insights and research highlights.

Pitolisant Shows Benefit for IH in Phase 3 Open-Label Trial, with Bruce Corser, MD

At SLEEP 2025, Bruce Corser, MD, presented open-label phase 3 data showing pitolisant led to significant symptom relief in idiopathic hypersomnia (IH). Over 80% of participants responded positively, with a 7.5-point drop in Epworth Sleepiness Scale scores, well above the 3-point threshold for clinical relevance.

Improvements spanned sleep inertia, brain fog, and daily function, with benefits appearing as early as week 1 and peaking by week 8. While pitolisant isn’t FDA approved for IH, the findings suggest real promise. A registrational phase 3 trial is planned, and higher doses will be evaluated to better understand its full potential in IH.

RLS Guidelines Advise Against Dopamine Agonists, With John Winkelman, MD, PhD

At SLEEP 2025, John Winkelman, MD, PhD, discussed the AASM’s updated RLS guidelines, which recommend transitioning patients off dopamine agonists due to the high risk of augmentation. Augmentation affects up to 50% of patients within 5 years. New guidelines favor iron therapies and alpha-2-delta ligands like gabapentin and pregabalin.

Winkelman emphasized a slow, careful tapering process, often requiring 6–12 months, and warned patients about temporary symptom flares. He encouraged clinicians to address other exacerbating factors and shared the RLS Curbside resource for peer guidance in managing complex cases.

Latest Pharmacotherapy Developments for Sleep Apnea, with Danny Eckert, PhD

At SLEEP 2025, Danny Eckert, PhD, highlighted major advances in drug-based therapies for OSA. While tirzepatide was recently FDA-approved for obese patients by reducing airway collapsibility through weight loss, Eckert noted that nearly half of the people with OSA are not obese. For them, therapies like AD109, a combination of atomoxetine and aroxybutynin, showed promising phase 3 results, with 25% achieving resolution and 50% seeing reduced severity. Potassium channel blockers and acetazolamide also show early efficacy.

Eckert emphasized that targeting the neurological and physiological causes of OSA marks a major shift in treatment strategy for this heterogeneous condition.

Other Highlights from SLEEP 2025

HCPLive Five at SLEEP 2025

At SLEEP 2025, HCPLive highlighted 5 standout interviews showcasing innovation in sleep medicine. Peter Colvonen, PhD, shared that VeNS, a wearable device, significantly reduced PTSD and insomnia symptoms. Danny Eckert, PhD, discussed pharmacotherapies like tirzepatide and AD109, advancing personalized OSA treatment. John Winkelman, MD, PhD, detailed AASM’s new RLS guidelines recommending alternatives to dopamine agonists due to augmentation risks.

The video also featured interviews with Chenlu Gao, PhD, who presented data linking irregular midday naps to increased mortality risk, as well as Patrick Strollo, MD, who shared phase 3 results on AD109, which significantly improved OSA in CPAP-intolerant patients. Strollo said that > 20% participants on AD109 achieved full disease control.

Axsome Presents Positive Phase 3 Data for AXS-12 in Narcolepsy at SLEEP 2025

At SLEEP 2025, Axsome Therapeutics presented positive phase 3 data showing AXS-12 (reboxetine) significantly reduced cataplexy attacks and excessive daytime sleepiness in narcolepsy. Results from the ENCORE and SYMPHONY trials support AXS-12’s potential as a meaningful treatment option, with patients on AXS-12 experiencing far fewer cataplexy attacks than those on placebo.

The drug, a norepinephrine reuptake inhibitor and cortical dopamine modulator, holds FDA Orphan Drug Designation for narcolepsy. Axsome also presented data on solriamfetol in OSA, showing improvements in attention, cognitive function, and daytime sleepiness, suggesting added benefit for patients with OSA-related cognitive impairment.