tasimelteon 4 MG/ML Oral Suspension [Hetlioz]

INDICATIONS AND USAGE Tasimelteon capsule is a melatonin receptor agonist. Tasimelteon capsules are indicated for the treatment of Non 24-Hour Sleep-Wake Disorder (Non-24) in adults ( 1 ) 1.1 Non-24-Hour Sleep-Wake Disorder (Non-24) Tasimelteon capsules are indicated for the treatment of Non-24-Hour in adults.

DOSAGE AND ADMINISTRATION Indicated Population Dosage Form Body Weight Recommended Dosage Non-24 ( 2.2 ) Adults Capsules Not applicable 20 mg one hour prior to bedtime Tasimelteon capsules and tasimelteon oral suspension are not substitutable ( 2.1 ) Administer at the same time every night ( 2.2 ) Take without food ( 2.4 ) 2.1 Non-Interchangeability between Tasimelteon Capsules and Tasimelteon Oral Suspension Tasimelteon capsules and tasimelteon oral suspension are not substitutable [see Clinical Pharmacology ( 12.3 )]. 2.2 Recommended Dosage for Tasimelteon Capsules for Non-24 Adults The recommended dosage of tasimelteon capsules in adults is 20 mg one hour before bedtime, at the same time every night. Because of individual differences in circadian rhythms, drug effect may not occur for weeks or months. 2.4 Important Administration Information Administer tasimelteon capsules without food [see Clinical Pharmacology ( 12.3 )]. If a patient is unable to take tasimelteon capsules at approximately the same time on a given night, they should skip that dose and take the next dose as scheduled.

WARNINGS AND PRECAUTIONS May cause somnolence: After taking tasimelteon capsules, patients should limit their activity to preparing for going to bed, because tasimelteon capsules can impair the performance of activities requiring complete mental alertness ( 5.1 ) 5.1 Somnolence After taking tasimelteon capsules, patients should limit their activity to preparing for going to bed. Tasimelteon capsules can potentially impair the performance of activities requiring complete mental alertness.

CONTRAINDICATIONS None. None ( 4 )

Mechanism of Action The mechanism by which tasimelteon exerts its therapeutic effect in patients with Non­-24 is unclear. However, tasimelteon is an agonist at melatonin MT 1 and MT 2 receptors which are thought to be involved in the control of circadian rhythms.