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Tasimelteon

Generic Name
Tasimelteon
Brand Names
Hetlioz
Drug Type
Small Molecule
Chemical Formula
C15H19NO2
CAS Number
609799-22-6
Unique Ingredient Identifier
SHS4PU80D9

Overview

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.

Background

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.

Indication

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.

Associated Conditions

  • Non 24 Hour Sleep Wake Disorder
  • Sleep Disturbance

FDA Approved Products

Hetlioz LQ
Manufacturer:Vanda Pharmaceuticals Inc.
Route:ORAL
Strength:4 mg in 1 mL
Approved: 2020/12/04
NDC:43068-304
Hetlioz
Manufacturer:Vanda Pharmaceuticals Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2020/12/04
NDC:43068-220
Tasimelteon
Manufacturer:Amneal Pharmaceuticals NY LLC
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/01/24
NDC:69238-2548
Tasimelteon
Manufacturer:Teva Pharmaceuticals, Inc.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2024/02/02
NDC:0480-4490
Tasimelteon
Manufacturer:Apotex Corp.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2024/01/05
NDC:60505-4665

Singapore Approved Products

No Singapore products found for this drug

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