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.
Sleep Disorders
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.
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.
Specificities and Sensitivities of OSA Screening Tools for People With HIV
In terms of screening for obstructive sleep apnea in people living with HIV, the STOP-BANG questionnaire had good sensitivity, whereas the Berlin questionnaire and the Epworth Sleepiness Scale demonstrated good specificity.
Pitolisant Add-On CPAP Therapy Reduces Excessive Daytime Sleepiness in OSA
Pitolisant may be used as an add-on therapy to continuous positive airway pressure in patients with obstructive sleep apnea suffering from residual diurnal somnolence.
Clinical Improvement Observed in Narcolepsy Trial Evaluating Once-Nightly Sodium Oxybate Formulation
Positive topline data from the phase 3 REST-ON trial evaluating FT218 (Avadel), an investigational, once-nightly formulation of sodium oxybate, showed that the treatment led to clinically meaningful improvement in patients with narcolepsy.
