Hetlioz -Tasimelteon

What is Hetlioz -Tasimelteon and what is it used for?

Hetlioz is a medicine indicated for the treatment of impaired sleep-wake cycle syndrome ("non-24" syndrome) in blind adults. Non-24 syndrome is a condition that almost exclusively affects blind people, who have a sleep-wake cycle that is not synchronized with day and night, often longer than the normal 24-hour cycle. As a result, patients fall asleep and wake up at unusual times.

Hetlioz contains the active substance tasimelteon.

Because the number of patients with non-24 syndrome is low, the disease is considered 'rare', and Hetlioz was designated an 'orphan medicine' (a medicine used in rare diseases) on 23 February 2011.

How is Hetlioz -Tasimelteon used?

Hetlioz is available as capsules (20 mg) and can only be obtained with a prescription.

Hetlioz is intended for long-term use. The recommended dose is one capsule per day, taken one hour before bedtime, at the same time each night. The medicine should be taken on an empty stomach.

How does Hetlioz-Tasimelteon work?

A hormone called melatonin plays a fundamental role in coordinating the body's sleep cycle. In people with a normal perception of light and dark, melatonin is produced in the hours of darkness and promotes sleep by acting on the melatonin receptors present in specific areas. The active ingredient in Hetlioz, tasimelteon, acts on the same receptors as melatonin to stimulate sleep and regulate sleep rhythm. When taken at an appropriate time each day, it can help restore a more normal wake-sleep cycle.

What benefit has Hetlioz-Tasimelteon shown during the studies?

Hetlioz has been shown to be effective in "helping patients adjust to their normal 24-hour sleep rhythm" in 2 main studies.

The first study, involving a total of 84 blind patients with non-24 syndrome, compared Hetlioz with placebo (a dummy treatment). The main measure of effectiveness was the percentage of patients able to adapt to the 24-hour wake-sleep rhythm, calculated by observing the changes in melatonin metabolism in the patients' urine over time. 20% of patients treated with Hetlioz (8 out of 40) were able to adjust to the 24-hour wake-sleep rhythm after 1 month of therapy compared with around 3% of patients treated with placebo (1 out of 38). Better results were seen in a subset of patients after 7 months of treatment, suggesting that patients may take weeks or months to respond to therapy.

In the second study, 57 patients were initially treated with Hetlioz for approximately 11 weeks. Patients who were able to adapt to the 24-hour wake-sleep rhythm (20 in total) were subsequently treated with Hetlioz or placebo for an additional 8 weeks, to see if the effect of Hetlioz was maintained over time. Of the 10 patients who continued to receive the medicine, at the end of the study 9 people had maintained their normal 24-hour sleep-wake rhythm compared to 2 of 10 patients treated with placebo.

What is the risk associated with Hetlioz-Tasimelteon?

The most common side effects with Hetlioz (which may affect more than 3 in 100 people) are headache, sleepiness, nausea and dizziness. These effects are usually mild to moderate and transient in nature.

For the full list of side effects and limitations reported with Hetlioz, see the package leaflet.

Why has Hetlioz -Tasimelteon been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Hetlioz's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that only around 20% of patients would be able to benefit from Hetlioz treatment. However, given the absence of approved therapies for non-24 syndrome, which is a debilitating condition, this response, albeit modest, was considered important. However, prolonged treatment is required to maintain the beneficial effects of the drug. As for safety, Hetlioz has been shown to be well tolerated, causing only a few mild side effects.

What measures are being taken to ensure the safe and effective use of Hetlioz-Tasimelteon?

A risk management plan has been developed to ensure that Hetlioz is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Hetlioz, including the appropriate precautions to be followed by healthcare professionals and patients.

More information about Hetlioz -Tasimelteon

On 3 July 2015, the European Commission issued a "Marketing Authorization" for Hetlioz, valid throughout the European Union.

For more information about Hetlioz therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.

Last update of this summary: 07-2015.

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