The Food and Drug Administration (FDA) has approved Hetlioz® (Tasimelteon; Vanda), a melatonin receptor agonist, for the treatment of adult and pediatric patients with nocturnal sleep disorders associated with Smith-Magenis Syndrome (SMS).
The approval was based on data from a 9-week, double-blind, placebo-controlled, crossover study examining the effects of Hetlioz in patients with SMS. The study consisted of two 4-week periods separated by a 1-week washout interval. Patients aged 16 years and over received 20 mg Hetlioz capsules and patients aged 3 to 15 years received a weight-dependent dose of an oral suspension. The primary endpoints were total sleep time at night and sleep quality at night from a parent / guardian-recorded diary. The effectiveness comparisons were based on the 50% of the nights with the poorest sleep quality and the 50% of the nights with the least night sleep in each 4 week period.
The results showed that treatment with Hetlioz was associated with a statistically significant improvement in sleep quality on the 50% worst nights compared to placebo. While Hetlioz showed improvements in the 50% worst night sleep time, the difference was found not to be statistically significant. The safety profile of Hetlioz was similar to that seen in previous studies for non-24-hour sleep-wake disorder.
Hetlioz 20 mg capsules are indicated for the treatment of nocturnal sleep disorders in patients aged 16 years and over with SMS. Hetlioz LQ oral suspension, supplied as 4 mg / ml in 48 ml and 158 ml bottles, is indicated for the treatment of night sleep disorders in pediatric patients 3 to 15 years of age with SMS. The products are not interchangeable.
The oral suspension formulation is expected to be available in the first quarter of 2021.
Please visit vandapharma.com for more information.
1. The FDA approves Hetlioz® (Tasimelteon) for the treatment of nighttime sleep disorders in Smith-Magenis syndrome. [press release]. Washington, DC: Vanda Pharmaceuticals, Inc; 1st December 2020.
2. Hetlioz® (Tasimelteon). Washington, DC: Vanda Pharmaceuticals, Inc: 2020.
This article originally appeared on MPR
General psychiatry insomnia sleep disorders