FDA Rejects sNDA for Hetlioz in Jet Lag Disorder
The FDA has rejected the supplemental New Drug Application for Hetlioz (tasimelteon; Vanda Pharmaceuticals) for the treatment of jet lag disorder.
Sleep-Wake Disorders
SLEEP-WAKE DISORDERS
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FDA Approves Wakix For Excessive Daytime Sleepiness In Adults With Narcolepsy
The Food and Drug Administration (FDA) approved Wakix (pitolisant; Harmony Biosciences) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.
Cognitive Behavioral Therapy for Insomnia May Improve Sleep, Mood in Chronic Pain
The treatment of veterans with chronic pain and insomnia with cognitive behavioral therapy for insomnia may improve sleep and mood, but not pain.
Pear Therapeutics Seeks Approval for Rx Digital Therapeutic to Treat Insomnia, Depression
Pear Therapeutics is seeking marketing authorization from the Food and Drug Administration (FDA) for Somryst, a prescription digital therapeutic (PDT) intended for use in the treatment of adults with chronic insomnia and depression.
Most Cannabis From Dispensaries Used for Sleep, Pain
De facto medical use of cannabis for symptom relief is common among adult-use dispensary customers in Colorado.
Single-Component Treatments Effective for Insomnia
Stimulus control therapy and sleep restriction therapy are viable single-component treatments for chronic insomnia.
FDA: Boxed Warning, Contraindication Added to Several Insomnia Medications
A new Boxed Warning will be required in the prescribing information for several insomnia medications following reports of serious injuries and deaths associated with complex sleep behaviors where patients engaged in activities while not fully awake.
Cognitive Behavioral Therapy Effective for Prenatal Insomnia
Cognitive behavioral therapy is an effective nonpharmacologic treatment for insomnia during pregnancy.
Conversion From Sleep Disorder to Neurodegeneration Studied
Predictors of neurodegeneration from idiopathic REM sleep behavior disorder (iRBD) have been identified.
Insomnia in Late Pregnancy Associated With Perinatal Anxiety
Gestational insomnia is associated with anxiety symptoms, both during pregnancy and after childbirth.
NDA Submitted for Novel Insomnia Treatment Lemborexant
The NDA includes data from two Phase 3 clinical trials (SUNRISE 1 and SUNRISE 2) which included approximately 2000 patients.
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