FDA Authorizes Digital Therapeutic for Sleep Disturbance in PTSD
NightWare is a smartwatch application that uses the Apple Watch and Apple iPhone platform.
Sleep Disorders
Valerian Quality, Storage Issues May Affect Sleep Outcomes
While valerian is considered a popular herbal supplement for managing sleep disorders, study outcomes related to its effectiveness have been inconsistent.
Wakix Indication Expanded to Include Cataplexy Treatment
The approval was based on data from two phase 3 trials (HARMONY CTP and HARMONY 1) that evaluated the efficacy and safety of pitolisant for the treatment of cataplexy.
Idiopathic Hypersomnia Study Evaluating Xywav Meets End Points
The multicenter, double-blind, placebo-controlled phase 3 study evaluated the efficacy and safety of Xywav in adults with idiopathic hypersomnia.
FDA Requires Boxed Warning Update for Benzodiazepines
Benzodiazepines are widely used to treat a variety of conditions including anxiety disorders, insomnia and seizures.
FDA to Review Tasimelteon for Smith-Magenis Syndrome
The applications are supported by positive results from a double-masked, 4-week, pivotal phase 2/3 clinical trial that compared the effects of tasimelteon to placebo in 25 patients with SMS.
Intrinsic Circadian Sleep-Wake Rhythm Disorders: Latest Guidance and Treatment
Melatonin and other melatonin receptor agonists have demonstrated efficacy in the treatment of circadian rhythm disorders in both pediatric and adult populations.
FDA Approves Xywav for Narcolepsy
The FDA has approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates; Jazz Pharmaceuticals) oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged ≥7 years with narcolepsy.
Consistent Effects Observed With Daridorexant in Second Insomnia Trial
Positive topline results were announced from the second pivotal phase 3 study evaluating daridorexant (Idorsia), an investigational dual orexin receptor antagonist, for the treatment of insomnia.
Sleep Disorders: Treatments
Prescription drugs for the treatment of various sleep disorders including insomnia, narcolepsy, non-24-hour sleep disorder, and restless leg syndrome.
