Core Insights - Nxera Pharma has announced positive top-line results from a Phase 3 study of daridorexant 50 mg for treating insomnia in South Korea, with plans to submit a marketing authorization application in Q1 2026 and expected approval in Q1 2027 [1][7] Company Overview - Nxera Pharma is a biopharma company focused on developing specialty medicines for unmet needs, operating in Japan and globally, and listed on the Tokyo Stock Exchange [12] - The company has established a commercial presence in Japan and is advancing an extensive pipeline through its unique drug discovery platform [12] Product Information - Daridorexant is a dual orexin receptor antagonist approved in Japan as QUVIVIQ® and is marketed in various regions including the US, Canada, and Europe [2][7] - The Phase 3 trial demonstrated significant improvements in subjective total sleep time, sleep onset latency, and wake after sleep onset compared to placebo, with p-values less than 0.0001 [5][7] Market Context - Insomnia affects approximately 15-25% of the adult population in South Korea, translating to about 6.5-11 million individuals, with a notable increase in chronic insomnia patients from 597,529 in 2018 to 722,440 in 2022 [3][10] - The condition is particularly prevalent among women and older adults, with 50% of treated patients aged 60 or above [10] Clinical Study Details - The Phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled study involving adult and elderly patients, with participants receiving either daridorexant 50 mg or placebo for 28 days [4][5] - The incidence of treatment-emergent adverse events was similar between the daridorexant and placebo groups, reported at 13.41% and 14.81% respectively [5]

Core Insights - Idorsia Ltd has published a study on the efficacy and safety of daridorexant for treating insomnia in women during menopausal transition, highlighting its potential benefits in this demographic [1][4][8]. Group 1: Study Findings - Daridorexant 50 mg significantly improved sleep and daytime functioning compared to placebo, with improvements in wake after sleep onset (WASO) by approximately 43 minutes, latency to persistent sleep (LPS) by about 34 minutes, and self-reported total sleep time by around 75 minutes [3][9][12]. - The incidence of somnolence and fatigue was low and comparable to placebo, with no increase in next-morning sleepiness observed [3][12]. Group 2: Clinical Implications - Insomnia disorder affects about one in four women during the menopausal transition, often remaining underdiagnosed and undertreated, indicating a need for clinicians to recognize and address this condition [4][22]. - The CELESTE study, funded by the Patient-Centered Outcomes Research Institute (PCORI), will evaluate the effectiveness and safety of daridorexant among approximately 900 peri- and post-menopausal women with insomnia over a 60-month period [10][11]. Group 3: Company Commitment - Idorsia is committed to advancing the science of sleep and insomnia, providing daridorexant at no cost to support the CELESTE study [6][7]. - The company aims to challenge existing medical paradigms and develop transformative medicines, positioning itself as a leading biopharmaceutical company [29][30].

Hello everybody. Well, today the topic is asleep. The missing piece in learning and well-being.And well, sit less, sleep more. It sounds simple. Yet today, many of us spending more time sitting, scrolling, and starting at screens than sleeping soundly in our beds.And well, this is the everyday life for many adolescents. And I think for many of you here, when I was a teenager, it was so hard to me to wake up in the morning. I hate my mom really when she tried to do this.I felt that she was interrupting the m ...

Study Findings - Long-term melatonin use linked to higher risk of heart failure and early death in adults with insomnia [1] - Individuals taking melatonin consistently for over a year were twice as likely to develop heart failure [3] - Individuals taking melatonin consistently for over a year were more than three times as likely to be hospitalized for heart failure [3] - 4.6% of melatonin users developed heart failure compared to 2.7% of non-users [3] - 19% of melatonin users were hospitalized for heart failure compared to 6.6% of non-users [3] Expert Opinions & Recommendations - Regular melatonin use may indicate underlying health issues [1] - Consider consulting a doctor if taking melatonin regularly [2] - Occasional melatonin use is not shown to cause harm [4] - More research is needed on melatonin supplements [5] - Over-the-counter availability does not guarantee safety for everyone or long-term use [5]

Stress Management in Teenagers - Stress can manifest physically and mentally in teenagers, impacting their well-being [1][3][6] - Isolation during formative years can exacerbate anxieties about academic performance [4][5] - Sleep deprivation is a common consequence of balancing studies and other commitments, leading to further stress [6] Yoga Nidra Technique - Yoga Nidra is a relaxation technique that aims to achieve a sleep-like state while maintaining awareness [7][8] - A typical Yoga Nidra session involves guided relaxation, setting intentions, body scans, breath awareness, and visualization [11][12][13] - Yoga Nidra does not require flexibility and can be practiced by anyone, anywhere [15][16] Benefits of Yoga Nidra - Studies suggest Yoga Nidra can reduce stress, anxiety, and insomnia [10] - Regular Yoga Nidra practice may improve sleep quality, leading to enhanced cognitive functions [17] - Yoga Nidra may increase hemoglobin levels and white blood cell count, potentially boosting immunity [20] - Yoga Nidra may decrease stress related to menstrual irregularities and rebalance hormones [20] - Yoga Nidra may decrease blood pressure [20] - One hour of Yoga Nidra is said to equate to four hours of sleep [18]

If you have ever found yourself tossing and turning and counting sheep unable to sleep, I can tell you from firsthand experience, you are not alone. In her new piece for The Atlantic titled American Insomnia, staff writer Jennifer Senior writes in part, "The cadences of modern life have proved enimical to sleep. For white collar professionals, it's hard to imagine a job without the woodpecker incursions of email or weekend and late night work. It's hard to imagine children assuing social media when it's how ...