Tasimelteon is a selective dual melatonin receptor agonist indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD). Occurring commonly in blind individuals without light perception, this condition is often characterized by periods of night-time insomnia and day-time sleepiness. In blind individuals, a lack of light stimulation causes an extension of the 24-hour circadian cycle and can lead to progressively delayed sleep onset. By activating melatonin receptors MT1 and MT2 in the suprachiasmatic nucleus of the brain, tasimelteon has been shown to improve sleep by resynchronizing the circadian rhythm through its "non-photic" mechanism. Tasimelteon is currently the only drug available for the treatment of N24HSWD and was granted orphan drug status by the FDA in 2010.
Tasimelteon oral capsules are indicated for the treatment of non-24 hour sleep-wake disorder in adult patients and for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome in patients ≥16 years old. Tasimelteon oral suspension is indicated for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome in patients 3 to 15 years of age.
Vanda Investigational Site, Çankaya, Ankara, Turkey
Vanda Investigational Site, Laval, Quebec, Canada
Brigham and Women's Hospital, Boston, Massachusetts, United States
Vanda Investigational Site, Schwerin, Germany
Vanda Investigational Site, Houston, Texas, United States
Vanda Investigational Site, Chevy Chase, Maryland, United States
Parexel Early Phase Clinical Unit, Baltimore, Maryland, United States
QPS Bio-Kinetic Clinical Applications, Springfield, Missouri, United States
INC Research Toronto, Inc., Toronto, Ontario, Canada
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