Category C—No reports describing the use of tasimelteon in human pregnancy have been located. The animal data suggest low risk but the absence of human pregnancy experience prevents a better assessment of the embryo-fetal risk.
No reports describing the use of tasimelteon during human lactation have been located. The molecular weight (about 245) and t½ of tasimelteon (1.3°) suggest that tasimelteon and metabolites will be excreted into breast milk, but the high plasma protein binding (90%) should limit the amount in milk.
The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to tasimelteon is increased by approximately 2-fold compared with younger patients.
No dose adjustment is necessary for patients with renal impairment.
Dose adjustment is not necessary in patients with mild or moderate hepatic impairment. Has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Therefore, not recommended for use in patients with severe hepatic impairment.