FDA to Review Daridorexant for Insomnia Treatment
The FDA has accepted for review the NDA for daridorexant, an investigational dual orexin receptor, for the treatment of insomnia in adults.
Insomnia
Hetlioz Approved for Nighttime Sleep Disturbances in Smith-Magenis Syndrome
The approval was based on data from a 9-week, double-blind, placebo-controlled, crossover study which assessed the effects of Hetlioz in patients with SMS.
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.
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.
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.
New Drug Product: Dayvigo
This slideshow shows drug information for Dayvigo. Click here for the complete Dayvigo monograph.
Dayvigo Now Available for Insomnia Treatment
Dayvigo (lemborexant; Eisai) is now available for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients.
Daridorexant Improves Sleep, Daytime Performance in Insomnia Study
Idorsia announced positive topline results from a phase 3 study of daridorexant, an investigational dual orexin receptor antagonist, for the treatment of insomnia.
FDA: Guidance on Digital Therapeutics for Psychiatric Disorders During COVID-19
The FDA has issued new guidance regarding the use of computerized behavioral therapy and other digital health therapeutic devices for psychiatric disorders during the coronavirus disease 2019 (COVID-19) pandemic.
