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.
De facto medical use of cannabis for symptom relief is common among adult-use dispensary customers in Colorado.
Stimulus control therapy and sleep restriction therapy are viable single-component treatments for chronic insomnia.
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 is an effective nonpharmacologic treatment for insomnia during pregnancy.
Predictors of neurodegeneration from idiopathic REM sleep behavior disorder (iRBD) have been identified.
Gestational insomnia is associated with anxiety symptoms, both during pregnancy and after childbirth.
The NDA includes data from two Phase 3 clinical trials (SUNRISE 1 and SUNRISE 2) which included approximately 2000 patients.
Symptoms of depression and PTSD may be increased in veterans with insomnia, which may be associated with an increased risk for suicidal behavior.
In the Phase 3 JET8 study (N=318), patients underwent a circadian challenge of 8 hours in advance to their usual bedtime.