|Adverse Event||HETLIOZ® (n=42)||Placebo (n=42)|
|Alanine aminotransferase increased||10%||5%|
|Upper respiratory tract infection||7%||0%|
|Urinary tract infection||7%||2%|
Reference: HETLIOZ® [prescribing information]. Vanda Pharmaceuticals Inc. 2014.
The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.
HETLIOZ® (tasimelteon) capsules are indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. HETLIOZ LQTM oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in patients 3 to 15 years of age.
Please see full US Prescribing Information.