Non-24-hour sleep–wake disorder

Project Sleep Launches the Sleep Helpline™ to Provide Free and Personalized Support for People Facing Sleep Issues and Sleep Disorders

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水曜日, 12月 6, 2023
Sleep, JD, Kleine–Levin syndrome, DSM-IV codes, REM, Narcolepsy, Sleep disorder, Patient, LOS, Obstructive sleep apnea, Idiopathic hypersomnia, Uncertainty, Sleep-related breathing disorder, Central sleep apnea, Eastern Time Zone, Caregiver, University, Upper airway resistance syndrome, Parasomnia, Diagnosis, Social, Doctor of Philosophy, Sleepwalking, Restless legs syndrome, Non-24-hour sleep–wake disorder, Pharmaceutical industry, Nursing

LOS ANGELES, Dec. 6, 2023 /PRNewswire/ -- Project Sleep, a nonprofit dedicated to raising awareness of sleep health, sleep equity, and sleep disorders, is thrilled to announce the official launch of the Sleep Helpline™, a new, professionally-staffed national helpline providing timely and trusted resources to help individuals navigate sleep issues and sleep disorders at every step of the journey.

Key Points: 
  • "An estimated 50-70 million Americans live with a chronic sleep disorder, yet the majority are undiagnosed," said Julie Flygare , JD, President & CEO of Project Sleep.
  • "We know that the path to finding accurate sleep disorder diagnosis, treatment, and support is often long, lonely, and inefficient.
  • This is why the new Sleep Helpline will meet people where they are in moments of uncertainty, to provide free and personalized one-to-one support and resources."
  • Special thanks to Jazz Pharmaceuticals and Harmony Biosciences for generously providing sponsorship funding to support the development of Project Sleep's new Sleep Helpline to support millions of people facing sleep issues and sleep disorders.

EEG Analysis and Animal Behavior in CNS Drug Development, Upcoming Webinar Hosted by Xtalks

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水曜日, 10月 4, 2023
Epilepsy, Central nervous system, Depression, Schizophrenia, Electroencephalography, Neuropharmacology, Attention deficit hyperactivity disorder predominantly inattentive, Non-24-hour sleep–wake disorder, Neuroscience, Toxicity, Biomarker, Doctor of Philosophy, CNS, Attention deficit, Pain, Risk, EEG, Drug discovery, Alzheimer's disease, Medical imaging, Pharmaceutical industry, Generic drug

TORONTO, Oct. 4, 2023 /PRNewswire-PRWeb/ -- EEG analysis (Electroencephalography) is becoming a promising translatable biomarker for predicting the likelihood that novel therapies and compounds will exhibit clinical efficacy early in preclinical development.

Key Points: 
  • In this free webinar, gain insights into electroencephalography (EEG) analysis as physiological endpoints to facilitate drug discovery, lead optimization or candidate compound selection as well as to serve for go/no go decisions.
  • The featured speaker will share case studies of EEG-based signatures in correlation with animal behavior which potentially may validate the EEG as endpoints for a set of translatable biomarkers bridging preclinical and clinical programs.
  • EEG-based signatures represent promising preclinical screens to quickly determine CNS penetration, drug-target engagement, evidence of efficacy, pharmacokinetic/pharmacodynamic profile, CNS safety and toxicity and pro-convulsant risk.
  • Join this webinar to gain insights into EEG analysis as physiological endpoints to facilitate drug discovery for CNS diseases.

Idorsia Convenes The Alliance for Sleep, a Force for Innovation and Change in the Insomnia Space

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木曜日, 12月 2, 2021
Psychiatry, Consultant, Disorder, Exercise, Diagnosis, Sleep, Non-24-hour sleep–wake disorder, Krystal, Physician, Risk, Behavioral medicine, Department, PMID, Substance abuse, Mental health, Sleep hygiene, Brain, General manager, MS, Academy of Family Physicians of India, Dementia, Behavioural sciences, SIX Swiss Exchange, Conditional sentence, Epidemiology, Research, Meta-analysis, Systematic review, Cognitive behavioral therapy, Alternative, Cardiovascular disease, IDIA, Population, Health, Education, Goal, Alliance, Adult, Sleep apnea, Neuroscience, Association, Wakefulness, Type 2 diabetes, Standard of care, Quality of life, Patient, Weill Institute for Cell and Molecular Biology, Lists of diseases, Awareness, Diet, Prevalence, Duke University, Gaps, Wake Forest School of Medicine, Science, Hyperkinesia, Pharmaceutical industry, Medicine

The Alliance for Sleep is sponsored by Idorsia U.S. and is a multidisciplinary committee built to promote education, awareness, and research on sleep and sleep disorders.

Key Points: 
  • The Alliance for Sleep is sponsored by Idorsia U.S. and is a multidisciplinary committee built to promote education, awareness, and research on sleep and sleep disorders.
  • Bhaskar S, Hemavathy D, Prasad S. Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities.
  • To achieve this, we will help develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.
  • Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017.

FDA Approves HETLIOZ® (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome

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火曜日, 12月 1, 2020
Sleep disorders, Branches of biology, Mobile telecommunications, Service industries, Text messaging, Circadian rhythm, Syndromes, Tasimelteon, Non-24-hour sleep–wake disorder, Sleep, SMS

The approval of HETLIOZ for the treatment of nighttime sleep disturbances in SMS was based on a single placebo-controlled efficacy study in this rare disorder, which studied both adults with SMS taking the HETLIOZ capsule and children with SMS taking the liquid formulation.

Key Points: 
  • The approval of HETLIOZ for the treatment of nighttime sleep disturbances in SMS was based on a single placebo-controlled efficacy study in this rare disorder, which studied both adults with SMS taking the HETLIOZ capsule and children with SMS taking the liquid formulation.
  • The safety profile of HETLIOZ in this study was similar to those seen in HETLIOZ studies previously conducted for the treatment of Non-24-Hour Sleep-Wake Disorder, and was similar between adults and children with SMS.
  • Various statements in this release, including, but not limited to statements regarding Vanda's ability to make HETLIOZ available to patients with nighttime sleep disturbances in SMS, are "forward-looking statements" under the securities laws.
  • Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf.

36-Month Post Marketing Surveillance Report For REMfresh®, The First And Only Drug-Free Sleep Product Of Its Type1, Shows Excellent Safety And Tolerability

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木曜日, 11月 5, 2020
Branches of biology, Circadian rhythm, Melatonin, Pineal gland, Sleep, Non-24-hour sleep–wake disorder, Melatonin receptor 1A

REMSU36involves a post-marketing analysis of the adverse events voluntarily reported by users of a real-world surveillance program reporting on the safety and tolerability profile of REMfresh.

Key Points: 
  • REMSU36involves a post-marketing analysis of the adverse events voluntarily reported by users of a real-world surveillance program reporting on the safety and tolerability profile of REMfresh.
  • It is estimated that 981,735 individual patients used the product during the three-year surveillance period of March 9, 2017 to March 9, 2020.
  • Melatonin is produced by the pineal gland in the brain and is the body's natural sleep hormone.
  • Melatonin levels normally begin to rise in the mid-to late evening and remain high for the majority of the night.

FDA Accepts HETLIOZ® (tasimelteon) Supplemental New Drug Application for Review in the Treatment of Jet Lag Disorder

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木曜日, 12月 20, 2018
Health, Pharmaceuticals policy, Pharmacy, Melatonin receptor agonists, Food and Drug Administration, Cyclopropanes, Tasimelteon, Prescription Drug User Fee Act, Non-24-hour sleep–wake disorder, Prescription drug, Pharmaceutical industry

WASHINGTON, Dec. 20, 2018 /PRNewswire/ --Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's Supplemental New Drug Application for HETLIOZ(tasimelteon)for the treatment of jet lag disorder.

Key Points: 
  • WASHINGTON, Dec. 20, 2018 /PRNewswire/ --Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's Supplemental New Drug Application for HETLIOZ(tasimelteon)for the treatment of jet lag disorder.
  • The FDA determined the action target date under Prescription Drug User Fee Act (PDUFA-VI), to be August 16, 2019.
  • HETLIOZis currently approved for the treatment of Non-24 Hour Sleep Wake Disorder.
  • HETLIOZhas been granted market authorization by the U.S. Food and Drug Administration and the European Medicines Agency.