tasimelteon

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Use and Dosing ⬇

Adult Dosing

Non-24-Hour Sleep-Wake Disorder

20 mg PO Daily taken before bedtime

Note:

Therapy should be taken on empty stomach without food
Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months

Pediatric Dosing

Safety and efficacy in pediatric patients have not been established

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Treatment of Non-24-Hour sleep-wake disorder (Non-24)

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product

Black Box Warnings ⬆ ⬇

N/A

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairement: No dose adjustments

Hepatic Dose Adjustment

Mild to moderate hepatic impairment: No dose adjustments
Severe hepatic impairment (Child-Pugh C): Not studied; use not recommended

Warnings/Precautions ⬆ ⬇

After initiating tasimelteon, patients should limit their activity to preparing for going to bed. Therapy may potentially impair the performance of activities requiring complete mental alertness

Interactions ⬆ ⬇

Hetlioz interacts with :

	Atazanavir
	Cetraxal
	Ciloxan
	Cimetidine
	Cipro
	Cipro IV
	Cipro XR
	Ciprofloxacin
	Cognex
	Enoxacin
	Fluvoxamine
	Luvox
	Luvox CR
	Mexiletine
	Mexitil
	Penetrex
	Proquin XR
	Reyataz
	Tacrine
	Tagamet
	Tagamet HB
	Zileuton
	Zyflo
	Zyflo CR

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Safety unknown. Caution advised while administering to a nursing woman.

Adverse Reactions ⬆ ⬇

PSYCHIATRY: Nightmare/abnormal dreams
CNS: Headache
LABTEST: Increased alanine aminotransferase
RESP: Upper respiratory tract infection
GU: Urinary tract infection

Clinical Pharmacology ⬆ ⬇

Sedative/hypnotic; binds to melatonin MT1 and MT2 receptors and induces sleep. These receptors are involved in maintenance of the circadian rhythm underlying the normal sleep-wake cycle
Extensively metabolized by liver; CYP450: 1A2 and 3A4
Renally excreted: 84% (<1% unchanged); feces: 4%
Half-life: 1.3 hrs; 1.3-3.7 hrs (metabolites)

Brands and Availability ⬆ ⬇

US Trade Name(s)

Hetlioz

US Availability

Hetlioz

CAPS: 20 mg

Canadian Trade Name(s)

N/A

Canadian Availability

N/A

UK Trade Name(s)

N/A

UK Availability

N/A

Australian Trade Name(s)

N/A

Australian Availability

N/A

Classification ⬆

Psychiatric

Sedatives/Hypnotics