Hetlioz | tasimelteon 

Drug Class: Sedative Hypnotic; Melatonin Receptor Agonist
Manufacturer: Vanda Pharmaceuticals, Inc
FDA Approval Date: January 31, 2014

What is Hetlioz

Hetlioz is a medication that binds to and activates the melatonin receptor in the brain. Hetlioz resembles the  natural melatonin hormone produced by our body during sleep. Melatonin is a hormone (chemical) produced  in the pineal gland from the amino acid tryptophan and is shown to help regulate sleep. Stimulation of melatonin receptors helps the body maintain normal circadian rhythms. 

Melatonin supplements, containing various concentrations of melatonin, are available over-the-counter.Hetlioz requires doctor’s prescription and it is not a supplement. Hetlioz is a melatonin receptor agonist and thought to have better therapeutic effects in patients with non-24-hour sleep-wake disorder (Non-24-Hour Disorder) in the blind than natural melatonin as it binds with much higher affinity with melatonin receptors. There is little scientific data supporting a beneficial effect of melatonin supplements in the treatment of this disorder. What is Hetlioz used for

Hetlioz is indicated for the treatment of non-24-hour sleep-wake disorder in completely blind individuals. Non-24-hour sleep-wake disorder is a body clock disorder in totally blind persons caused by the inability to perceive light to maintain a normal sleep schedule. Those with this disorder have problems staying asleep or falling asleep. Hetlioz has been shown to correct this abnormality as well as improve sleep. Approximately 100,000 people in the United States have this condition and Hetlioz is the first FDA treatment approved for this disorder.

How well does Hetlioz work

The effectiveness of Hetlioz was evaluated in totally blind individuals with non-24-hour sleep-wake disorder in two studies:

·n study 1:84 patients were placed in a group either taking Hetlioz 20 mg or placebo one hour before bedtime, at the same time every night for 6 months. In a second study 20 patients were randomly withdrawn after being treated for 12 weeks with Hetlioz 20 mg one hour before bedtime, at the same time every night. They were placed in a group either receiving Hetlioz 20 mg for 8 weeks or placebo. In both studies Hetlioz was more effective than placebo. Hetlioz treatment resulted in greater than 45 minutes increase in nighttime sleep and greater than 45 minutes decrease in daytime sleep.

What are interesting facts about Hetlioz

• Hetlioz is the first FDA-approved therapy for treatment of non-24-hour sleep-wake disorder.
• It is similar to ramelteon (Rozerem)

What is the dosage of Hetlioz

Hetlioz is available as 20 mg capsules and the recommended dose of Hetlioz is 20 mg per day. 

• Hetlioz should be taken before bedtime at the same time every night and without food.
• If you forget to take Hetlioz at the same time on a given night, you should skip that dose.
• Limit activities after taking this medicine.
• It may take weeks or months to see effects.
• No dosage adjustment is necessary for renal impairment.
• No dosage adjustment necessary for mild to moderate liver impairment. It is not recommended for individuals with severe liver impairment.

What are the common side effects of Hetlioz

• Headache
• Drowsiness
• Nightmares
• Elevated liver enzymes in the blood
• Urinary tract infection
• Elderly patients (> 65 years) have higher risk of adverse reactions than younger patients.

Hetlioz Drug Interactions

Hetlioz should not be taken with strong inhibitors (e.g., fluvoxamine) of liver enzymes that breakdown Hetlioz. Such combinations may result in large increases in drug concentrations of Hetlioz leading to increased side effects.

Hetlioz should not be taken with  drugs (e.g., rifampin) that increase the breakdown of Hetlioz in the liver. Such combinations may decrease blood levels and effect of Hetlioz.

What is the Cost of Hetlioz

Hetlioz will not be available for sale until Spring 2014. The price of Hetlioz is not available at this time. 

How to obtain prescription cost assistance for Hetlioz

Patient Assistance Program Center. http://www.rxassist.org/

Call 1-888-4PPA-NOW (1-888-477-2669) for any questions regarding eligibility and application process.

References

Hetlioz (tasimelteon) Prescribing Information