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 Disorders
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.
CPAP Alleviates Depression in Obstructive Sleep Apnea
The benefit of CPAP was seen for depression but not anxiety symptoms in patients with obstructive sleep apnea.
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.
Is Melatonin Beneficial for Pediatric Patients With Sleep Disorders?
A recently published systematic review investigated the benefits and risks of melatonin supplementation for pediatric patients with sleep disturbances.
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.
Treatment-Naive Women Commonly Overprescribed Zolpidem
Higher-than-recommended dosages were commonly prescribed to women who were new zolpidem users.
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