Hetlioz authorised for nocturnal sleep problems in Smith-Magenis syndrome

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.

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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

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