Insomnia is a common sleep disorder involving persistent difficulty falling asleep, staying asleep, or getting quality sleep despite enough opportunity. It can be acute or chronic and may lead to daytime fatigue, mood changes, and reduced cognitive performance.
GLP-1 drugs discovered accidentally in anglerfish research now treat conditions beyond diabetes including kidney disease, sleep apnea, and addiction. The global diabetes therapeutics market is projected to reach $241.5 billion by 2030, growing at 12.4% annually.
Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.
GSK agreed to license linerixibat to Alfasigma in a deal worth up to $690 million, while Eisai received orphan drug designation in Japan for E2086, a novel selective orexin 2 receptor agonist for narcolepsy.
The FDA approved pitolisant (Wakix) for treating cataplexy in children ages 6 and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA has expanded approval of Wakix (pitolisant) to treat cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-controlled substance approved for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA has approved Harmony Biosciences' Wakix (pitolisant) for treating cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA has approved pitolisant tablets for treating cataplexy in pediatric patients aged 6 and older with narcolepsy, making it the only non-scheduled therapy approved for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA accepted Takeda's NDA for oveporexton (TAK-861), an oral orexin receptor 2 agonist for narcolepsy type 1, and granted Priority Review with a PDUFA goal date in Q3 2026. The drug could become the first approved orexin agonist.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07603687 |
Brief Behavioral Intervention for Insomnia Among Adults With Sleep Disturbances |
NOT_YET_RECRUITING | NA |
| NCT07595185 |
Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder |
NOT_YET_RECRUITING | NA |
| NCT07588035 |
Artificial Intelligence (AI)-Assisted Sleep Intervention for Insomnia in Older Adults With Subjective Cognitive Decline |
NOT_YET_RECRUITING | NA |
| NCT07582809 |
Clinical Investigation to Observe the Long-term Safety and Efficacy of the Digital Medical Device 'BELL-001' in Patients Diagnosed With Insomnia |
NOT_YET_RECRUITING | NA |
| NCT07579871 |
Sleep and Stroke Rehabilitation Study |
RECRUITING | |
| NCT07576348 |
Electroacupuncture for Insomnia in Patients With Chronic Sciatica Due to Lumbar Disc Herniation: a Randomized Controlled Trial |
NOT_YET_RECRUITING | NA |
| NCT07565974 |
THC Versus THC/CBD Versus Placebo to Improve Sleep Quality for Patients With Solid Organ Cancer and Insomnia |
NOT_YET_RECRUITING | PHASE2 |
| NCT07559305 |
A Theory-based Sleep Hygiene Education for Insomnia Patients |
NOT_YET_RECRUITING | NA |
| NCT07555743 |
Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia |
NOT_YET_RECRUITING | PHASE4 |
| NCT07553364 |
Auditory Stimulation for Insomnia and Depression |
NOT_YET_RECRUITING | NA |
