Richard K Bogan

Medical University of South Carolina, SleepMed Inc

Background Norepinephrine reuptake inhibitors such as atomoxetine (ato) can improve OSA by increasing pharyngeal muscle activity. Mineralocorticoid antagonists such as spironolactone, may potentiate the reduction of OSA severity and reduce blood pressure. We evaluated whether adding spironolactone to atomoxetine (ato-spiro) improved responses in hy...

What is this summary about? This is a plain language summary of a published article in the journal Sleep . Narcolepsy is a sleep condition that has 2 different subtypes: narcolepsy type 1 and narcolepsy type 2. These are called NT1 and NT2 for short. Sodium oxybate (SXB) is approved to treat excessive daytime sleepiness (EDS) and cataplexy. People...

This perspective on alternatives to Positive Airway Pressure therapy for the treatment of obstructive sleep apnea summarizes the proceedings of a focus group that was conducted by the Sleep Research Society Foundation. This perspective is from a multi-disciplinary panel of experts from sleep medicine, dental sleep medicine, and otolaryngology that...

Background In the REST-ON clinical trial (NCT02720744), mean sleep latency on the Maintenance of Wakefulness Test (MWT) was significantly improved with extended-release once-nightly sodium oxybate (ON-SXB) vs placebo (P < 0.001) in participants with narcolepsy. This post hoc analysis assessed response to treatment and improvement in excessive dayti...

Low-sodium oxybate (LXB) is approved for treatment of narcolepsy in patients aged 7 years and older and treatment of idiopathic hypersomnia in adults. LXB contains the same active moiety with 92% less sodium than sodium oxybate (SXB). As the indication for oxybate treatment in patients with idiopathic hypersomnia is new and allows for individualize...

Introduction Low-sodium oxybate (LXB; Xywav®) is approved by the US Food and Drug Administration for the treatment of idiopathic hypersomnia in adults. To examine the long-term safety of LXB in this population, this post hoc analysis evaluated treatment-emergent adverse events (TEAEs) over time in a phase 3, double-blind, placebo-controlled, random...

Introduction Cognitive impairment is a burdensome symptom in many patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA). Solriamfetol (Sunosi®) is a dopamine/norepinephrine reuptake inhibitor, with agonistic properties at TAAR1 and serotonin 1A receptors, approved to treat EDS associated with OSA (37.5–150 m...

Introduction Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) is an effective and safe treatment for excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy. This post hoc analysis assessed efficacy in female and male participant subgroups from the phase 3 REST-ON trial. Methods REST-ON (NCT02720744) participants (≥16 years) with n...

Introduction Low-sodium oxybate (LXB; Xywav®) is approved by the US Food and Drug Administration to treat excessive daytime sleepiness or cataplexy in patients ≥7 years of age with narcolepsy, and idiopathic hypersomnia in adults. LXB contains the same active moiety as high-sodium oxybates (sodium oxybate [SXB, Xyrem®] and fixed-dose SXB [Lumryz™])...

Background Once-nightly sodium oxybate (ON-SXB), an extended-release oxybate formulation, yielded significant (P < 0.001 at 6 g, 7.5 g, and 9 g) reductions in cataplexy episodes in participants in the phase 3 REST-ON clinical trial (NCT02720744). This post hoc analysis from REST-ON further characterized changes in cataplexy episodes in participants...

What is this summary about? This plain language summary describes a clinical study that looked at the effects of a medicine called low-sodium oxybate (or LXB; XYWAV ® [calcium, magnesium, potassium, and sodium oxybates]) in adults with narcolepsy. Narcolepsy is a rare brain disorder that can make people feel extremely sleepy during the day or have...

This consensus conference report summarizes discussions on sleep apnea care and management. Our goal is to simplify the journey to optimize success for individuals at risk of obstructive sleep apnea and to facilitate diagnostics, monitoring and communication among the entire healthcare team including patients, primary care physicians, sleep special...

Narcolepsy and idiopathic hypersomnia are chronic conditions that negatively affect alertness, mental and physical energy, functioning, and quality of life (QoL). Calcium, magnesium, potassium, and sodium oxybates (low-sodium oxybate; LXB) is an oxybate formulation with 92% less sodium than sodium oxybate (SXB; a treatment for narcolepsy) and the s...

Objectives: We used a high-throughput assay of 5000 plasma proteins to identify biomarkers associated with periodic limb movements (PLM) and restless legs syndrome (RLS) in adults. Methods: Participants (n = 1410) of the Stanford Technology Analytics and Genomics in Sleep (STAGES) study had blood collected, completed a sleep questionnaire, and u...

Study objectives: The purpose of this study was to evaluate the efficacy and safety/tolerability of bilateral high-frequency tonic motor activation (TOMAC) in patients with medication-refractory restless legs syndrome (RLS). Methods: RESTFUL was a multicenter, randomized, double-blind, sham-controlled trial in adults with medication-refractory m...

Study Objectives To evaluate long-term efficacy and safety of tonic motor activation (TOMAC) for treatment of medication-refractory moderate-to-severe primary restless legs syndrome (RLS). Methods In the parent study (RESTFUL), adults with refractory RLS were randomized to active TOMAC or sham for 4 weeks followed by 4 weeks of open-label active T...

Study objectives: To evaluate 6-month efficacy and safety of low-sodium oxybate (LXB) in people with idiopathic hypersomnia during an open-label extension period (OLE) of a phase 3 clinical trial. Methods: Efficacy measures included the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS), Patient Global Impression of Cha...

Introduction Mazindol is the first partial orexin 2 receptor agonist and triple monoamine reuptake inhibitor in development for the treatment of narcolepsy. A novel extended release (ER) formulation was developed to allow once-daily dosing and may provide a differentiated treatment option. (ClinicalTrials.gov Identifier: NCT04923594). Methods Stud...

Introduction Efficacy secondary outcome measure Functional Outcomes of Sleep Questionnaire, Short Version (FOSQ-10] was collected in the Phase 2 (POLARIS, NLS-1021), multicenter (n=21) study of mazindol ER in adult participants with narcolepsy type 1 (NT1) or type 2 (NT2) (ClinicalTrials.gov Identifier: NCT04923594). Methods Adults diagnosed with...

Introduction An external collar with ~30cmH2O vacuum applied to the anterior neck can expand the oro- and naso-pharynx and improve Pcrit (Kato et al 2015- PMID: 25614595. The hypothesis of SUPRA (Study Using Negative Pressure to Reduce Apnea - NCT04861038) is that the self-contained vacuum device (aerSleep® II) can treat obstructive sleep apnea (OS...

Introduction Tonic motor activation (TOMAC) is a noninvasive medical device therapy that has been shown to reduce symptoms of refractory restless legs syndrome (RLS). Here, we evaluated the effects of TOMAC on subjective sleep quality. Methods One hundred and thirty-three adults with primary moderate-severe refractory RLS were 1:1 randomized to TO...

Introduction Narcolepsy, particularly type 1 (NT1), is often comorbid with obesity. FT218 (LUMRYZ™) is an investigational once-nightly sodium oxybate (ON-SXB) formulation whose efficacy and safety were shown in the phase 3 REST-ON clinical trial (NCT02720744). Methods REST-ON was a 13-week, randomized (1:1), double-blind, placebo-controlled multic...

Introduction Mazindol ER (extended-release), the first partial orexin-2 receptor agonist and triple mono-aminergic reuptake inhibitor, has demonstrated efficacy and safety in significantly reducing excessive daytime sleepiness (EDS) and cataplexy attacks in narcolepsy type 1 (NT1) and type 2 (NT2) patients (POLARIS, Study NLS-1021). This efficacy w...

Study objectives: Post hoc analyses from the phase 3 REST-ON trial evaluated efficacy of extended-release once-nightly sodium oxybate (ON-SXB; FT218) vs placebo for daytime sleepiness and disrupted nighttime sleep in narcolepsy type 1 (NT1) and 2 (NT2). Methods: Participants were stratified by narcolepsy type and randomized 1:1 to ON-SXB (4.5 g,...

Background: Many people worldwide experience obstructive sleep apnea, which is associated with medical and psychological problems. Continuous positive airway pressure (CPAP) is an efficacious therapy for obstructive sleep apnea, but its effect is limited by nonadherence. Studies show that personalized education and feedback can increase CPAP adher...

Background: Sleep disruptions experienced by patients with obstructive sleep apnea (OSA) can lead to excessive daytime sleepiness (EDS) and significantly impact patients' quality of life. EDS may persist despite use of continuous positive airway pressure (CPAP) therapy. Small molecules that target the orexin system, which has a known role in sleep...

Background: The safety and efficacy of low-sodium oxybate (LXB; Xywav®) were established in a randomized, double-blind, placebo-controlled, phase 3 withdrawal study in adults with narcolepsy with cataplexy; however, the longer-term safety profile has not yet been examined. The aim of the current analysis was to assess the time of onset and duratio...

Study objectives: Idiopathic hypersomnia (IH) is a chronic disorder characterized by excessive daytime sleepiness unexplained by another disorder or drug/medication use. Although the orexinergic system plays a role in sleep-wake regulation, orexin A levels in the cerebrospinal fluid are normal in people with IH. This phase 1b, randomized, placebo-...

Idiopathic hypersomnia is a sleep disorder of neurologic origin characterized by excessive daytime sleepiness, with sleep inertia, long, unrefreshing naps, and prolonged nighttime sleep being key symptoms in many patients. Idiopathic hypersomnia is described in the International Classification of Sleep Disorders, 3rd Edition as a central disorder o...

Objectives Treatment for narcolepsy with sodium oxybate (SXB) has required twice-nightly dosing, at bedtime and 2.5–4 hours later. This study evaluated the pharmacokinetics of FT218, an investigational, extended-release, once-nightly formulation of SXB (ON-SXB), vs twice-nightly SXB. Methods In this phase 1, open-label trial, healthy volunteers we...

Obstructive sleep apnea (OSA), a disease associated with excessive sleepiness and increased cardiovascular risk, affects an estimated 1 billion people worldwide. The present study examined proteomic biomarkers indicative of presence, severity, and treatment response in OSA. Participants (n = 1391) of the Stanford Technology Analytics and Genomics i...

BACKGROUND Many people worldwide experience obstructive sleep apnea, which is associated with medical and psychological problems. Continuous positive airway pressure (CPAP) is an efficacious therapy for obstructive sleep apnea, but its effect is limited by nonadherence. Studies show that personalized education and feedback can increase CPAP adheren...

Background: Lower-sodium oxybate (LXB) is an oxybate medication with the same active moiety as sodium oxybate (SXB) and a unique composition of cations, resulting in 92% less sodium. LXB was shown to improve cataplexy and excessive daytime sleepiness in people with narcolepsy in a placebo-controlled, double-blind, randomized withdrawal study (NCT0...

Background Excessive daytime sleepiness (EDS), a primary symptom of obstructive sleep apnea (OSA), negatively affects functioning and quality of life (QoL). EDS can persist despite primary airway therapy, and often remains unmanaged, potentially due to inadequate provider-patient communication. Ethnographic research was conducted to assess provider...

Introduction Once-nightly sodium oxybate (ON-SXB; FT218) was evaluated for treatment of narcolepsy in the phase 3 REST-ON trial (NCT02720744). Significant improvement was shown for the three coprimary endpoints mean sleep latency on the Maintenance of Wakefulness test (MWT), Clinical Global Impression of Improvement (CGI-I) rating, and weekly numbe...

Introduction Obstructive sleep apnea (OSA) is characterized by recurrent, partial or complete obstructive respiratory events accompanied by interruptions in sleep with frequent arousals, deoxygenation, and/or sleep disturbance. The present study profiled the largest array of plasma proteins, to date, to contribute to the identification of proteomic...

Introduction Rapid eye movement (REM) sleep detected by polysomnography (PSG) occurring within 15 minutes of nocturnal sleep (sleep onset REM period; SOREMP) is a known biomarker for hypocretin-deficient narcolepsy. However, the SOREMP is often underappreciated when observed in patients undergoing routine diagnostic sleep testing, evidenced by the...

Introduction Periodic limb movements (PLMs) are episodes of involuntary, repetitive muscle movements that are highly associated with restless legs syndrome (RLS). Although PLMs and RLS are reportedly two separate phenomena, both are tightly correlated and may result from a similar pathology. The present study profiled plasma protein biomarkers of P...

Introduction Treatment-emergent adverse events (TEAEs) were analyzed during a 6-month open-label extension (OLE) of a double-blind, placebo-controlled, randomized withdrawal trial (NCT03030599) of lower-sodium oxybate (LXB; Xywav™). LXB is FDA approved for treating cataplexy or excessive daytime sleepiness in patients with narcolepsy aged ≥7 years...

Introduction In the REST-ON trial (NCT02720744), once-nightly sodium oxybate (ON-SXB; FT218) was associated with significant improvement vs placebo for mean sleep latency on the Maintenance of Wakefulness test (MWT) and Clinical Global Impression of Improvement (CGI-I) rating in the overall population (both P<0.001) and in subgroups of participants...

Background: Sodium oxybate has been recognized as a gold standard for the treatment of disrupted nighttime sleep due to narcolepsy. Its short half-life and immediate-release formulation require patients to awaken 2.5-4 h after their bedtime dose to take a second dose. A novel extended-release, once-nightly sodium oxybate formulation (ON-SXB; FT218...

Lower-sodium oxybate (LXB) is an oxybate medication approved to treat cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy 7 years of age and older in the United States. LXB was developed as an alternative to sodium oxybate (SXB), because the incidence of cardiovascular comorbidities is higher in patients with narcolepsy and...

Background Idiopathic hypersomnia is a central hypersomnolence disorder mainly characterised by excessive daytime sleepiness, with prolonged night-time sleep and pronounced sleep inertia. Until August, 2021, no medication had regulatory approval for the treatment of idiopathic hypersomnia. This study aimed to evaluate the safety and efficacy of low...

Purpose To report the efficacy and safety of lower-sodium oxybate (LXB; Xywav®) during the open-label titration and optimization period (OLT) and stable-dose period (SDP) in a clinical study for the treatment of idiopathic hypersomnia. Patients and Methods Data were collected during treatment titration and optimization in a phase 3 randomized with...

Background: Excessive daytime sleepiness (EDS), a primary symptom of obstructive sleep apnea (OSA), negatively affects functioning and quality of life (QoL). EDS can persist despite primary airway therapy, and often remains unmanaged, potentially due to inadequate provider-patient communication. Ethnographic research was conducted to assess provide...

Introduction FT218 is an investigational, once-nightly, controlled-release formulation of sodium oxybate for the treatment of narcolepsy. The purpose of this post hoc analysis of the REST-ON study was to evaluate the effect of FT218 on measures of excessive daytime sleepiness (EDS) in patients with narcolepsy subtypes 1 (NT1) and 2 (NT2). Methods...

Introduction Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder characterized by excessive daytime sleepiness. A common feature is sleep inertia, which is prolonged difficulty waking up accompanied by confusion, disorientation, poor motor coordination, and repeated returns to sleep. Sleep inertia is burdensome to patients, resul...

Introduction Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder characterized by excessive daytime sleepiness, prolonged nighttime sleep, and sleep inertia. No US/EU medication is approved for treatment of IH. Lower-sodium oxybate (LXB; Xywav™; previously designated JZP-258) is a novel oxybate treatment with 92% less sodium than...

Introduction FT218 is an investigational, once-nightly, controlled-release formulation of sodium oxybate for the treatment of narcolepsy. The purpose of this post hoc analysis of the REST-ON study was to evaluate the effect of FT218 on measures of excessive daytime sleepiness (EDS) in patients with narcolepsy with or without stimulant use. Methods...

Introduction Patients with narcolepsy are more likely to be obese compared with healthy controls. FT218 is an investigational once-nightly sodium oxybate formulation for the treatment of narcolepsy. Here, we report on changes in weight-related clinical values with FT218 treatment in patients with narcolepsy. Methods This was a randomized, double-b...

Introduction This analysis evaluated treatment-emergent adverse events (TEAEs) during a double-blind, placebo-controlled, randomized withdrawal trial (NCT03030599) of lower-sodium oxybate (LXB; Xywav™), an FDA-approved treatment for excessive daytime sleepiness or cataplexy in narcolepsy. Methods At study entry, participants were taking sodium oxy...