Study design—RESET: Patients who received HETLIOZ® and had entrained melatonin circadian rhythms (N=20) were randomized in RESET to receive placebo (n=10) or continue treatment with HETLIOZ® 20 mg (n=10) for 8 weeks. Entrainment is the calculated time of peak melatonin levels occurring at approximately the same time of day.1
RESET, Randomized Withdrawal Study of the Efficacy and Safety of Tasimelteon.
*Patients in whom the calculated time of peak melatonin levels occurred at approximately the same time of day.1
References: 1. HETLIOZ® [prescribing information]. Vanda Pharmaceuticals Inc. 2014. 2. Data on file. 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.