Hetlioz is a selective dual melatonin receptor agonist indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD). Occurring commonly in blind individuals without light perception, this condition is often characterized by periods of night-time insomnia and day-time sleepiness. In blind individuals, a lack of light stimulation causes an extension of the 24-hour circadian cycle and can lead to progressively delayed sleep onset. By activating melatonin receptors MT1 and MT2 in the suprachiasmatic nucleus of the brain, hetlioz has been shown to improve sleep by resynchronizing the circadian rhythm through its “non-photic” mechanism. Hetlioz is currently the only drug available for the treatment of N24HSWD and was granted orphan drug status by the FDA in 2010.
The most common adverse reactions are headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infections. There are currently no adequate or well-controlled studies that suggest that hetlioz is safe to use during pregnancy. In animal studies, administration of hetlioz during pregnancy resulted in developmental toxicity (embryofetal mortality, neurobehavioral impairment, and decreased growth and development in offspring) at doses greater than those used clinically. During clinical trials, rats did not self-administer hetlioz, suggesting that the drug does not have a potential for abuse.
Strength: 20 Mg
Pill Imprint: VANDA 20 Mg
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