Sleep Disorders

Ned Sharpless, MD, the director of the National Cancer Institute, has been named to the position of acting FDA Commissioner. The announcement was made just a week after the current commissioner, Scott Gottlieb, MD, announced his plans to resign in early April.

A Prescription Drug User Fee Act action date has been set for Dec. 27, 2019.

Neurology News Network for the week of March 9, 2019.

The 23rd FDA commissioner’s resignation is effective in about a month; his successor has not yet been named.

The new clinical practice guideline provides 9 recommendations, 4 of which are strongly recommended, for PAP treatment of OSA and is intended for use in conjunction with other AASM guidelines.

The pediatric critical care medicine attending physician in the Department of Anesthesiology and Critical Care Medicine at the Children’s Hospital of Philadelphia spoke about how physicians can better address brain death in pediatric patients.

The field of neurology is gaining a more robust understanding of some of the mechanisms at play in excessive daytime sleepiness, but the progress has not spread evenly across different sleep disorders.

The framework consists of 2 documents that expand on the agency’s plans for its risk-based approach for describing drugs, devices, and biologics, including those designated as regenerative medicine advanced therapies.

Preliminary results show that the whole genome information can be used to assess the association between predicted gene expression in different parts of the brain and sleep, suggesting where brain genes are expressed matter for variability in sleep.

If approved, pitolisant would be the first new therapy in more than 15 years indicated for treatment of both excessive daytime sleepiness and cataplexy in adults with narcolepsy.

It turns out that sleep deprivation has an effect not only on the traditional concept of “beauty,” but also on whether a person is perceived as being socially desirable.

At the end of the 6-month, placebo-controlled treatment period, treatment with lemborexant at 5 mg or 10 mg resulted in statistically significant improvements compared to placebo in patient-reported sleep onset latency, subjective sleep efficiency, and subjective wake after sleep onset.

Neurology News Network for the week of January 26, 2019.

A 67-year-old woman presents with symptoms of symptoms of daytime fatigue and sleeplessness at night due to excessive nighttime movements over the course of three months. Her husband is concerned that she could be having seizures.

Overall, there were no statistically significant or clinically relevant effects of bedtime administration of lemborexant on next-morning driving performance in healthy adult and elderly volunteers.

Neurology News Network for the week of January 19, 2019.

The NDA was based on the results of 2 pivotal phase 3 clinical studies, SUNRISE 1 and SUNRISE 2, which enrolled approximately 2000 patients, as well as safety studies.

The associate professor in the department of psychiatry at NYU Langone spoke about the relationship between slow-wave sleep disruption and Alzheimer disease.

The AAN position statement author further addressed the opposing position of the Nevada law, the AAN’s position on brain death, and what clinicians need to know in regard to determining it.

The Chair of the AAN’s Ethics, Law and Humanities Committee spoke to the American Academy of Neurology’s goal to improve the consistency of determining brain death.

A number of tools that clinicians can use to better understand their patients’ sleep quantity and quality.

The Clinical Director of the NHGRI spoke about the impact of the NIH program and its future development.

The director of the sleep clinic and assistant professor of neurology at Harvard Medical School discussed what has been learned about pediatric narcolepsy in the last decade, as well as what questions remain unanswered.

Neurology News Network for the week of January 5, 2019.

The position statement’s author noted that a lack of specificity in laws and inconsistencies in protocols has led to confusion surrounding brain death in several high-profile cases.

The program’s director spoke about its genesis and evolution into a more widespread initiative which has helped improve next-generation genome sequencing.

The FDA notice stated that these discontinuations are the result of a business decision by manufacturer GlaxoSmithKline.

The director of the sleep clinic and assistant professor of neurology at Harvard Medical School spoke about the state of pediatric narcolepsy management and diagnosis.

The agency has decided that a major amendment is needed for the therapy’s NDA and has pushed the PDUFA goal date to March 20, 2019.

The principal research scientist at Neuroscience Research Australia and an associate professor of medicine at the University of New South Wales provided more insight into the latest knowledge regarding sleep apnea phenotyping and its role in the development of targeted pharmacotherapies.