How Hetlioz Compares to Melatonin to Treat Non-24 in Blind People

Non-24-hour sleep-wake disorder is a circadian rhythm disorder in which a person's body doesn't synchronize with a 24-hour day. This condition commonly affects blind individuals, but not exclusively. Hetlioz (tasimelteon) is an FDA-approved drug used for the treatment of non-24-hour sleep-wake disorder (non-24). How does it compare to melatonin, the standard treatment for this disorder?

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Research Comparisons Between Hetlioz and Melatonin

There have been no clinical research trials that compare the use of Hetlioz and melatonin in a head-to-head fashion. The U.S. Food and Drug Administration (FDA) approved Hetlioz based on placebo-controlled trials. This means that Hetlioz, which acts on receptors in the brain for melatonin, was more effective for treating non-24 than placebo pills. Its effectiveness has not yet been directly compared to taking over-the-counter melatonin, which has previously been the standard of care for this condition.

Standard Recommendations for Treatment

In its last guidelines from 2007, prior to the availability of Hetlioz, the American Academy of Sleep Medicine (AASM) recommends the use of melatonin for the treatment of non-24. In order to stabilize the genetically determined circadian rhythms that can lead to cycles of insomnia and excessive sleepiness, melatonin can be highly effective. This stabilization is called entrainment. The rhythms of sleep and wakefulness in blind people can be aligned, or entrained, to the natural day-night patterns.

This can be accomplished with very low doses of over-the-counter melatonin. It is important to select a reputable manufacturer that ensures the quality and precise contents of the product. In general, small doses (0.3 milligrams [mg]) can be used for entrainment of blind people with non-24. In comparison, many supplement products often contain 3 mg of melatonin (10 times as much as is required) or even more. This excessive melatonin may flood the system, counteracting the benefits and potentially leading to side effects.

The timing of the melatonin dose is critical. It may be difficult to stabilize the circadian rhythm, and sometimes the condition may recur if a dose is missed. It may require the assistance of a sleep specialist to ensure that the dose amount and timing are appropriate.

Assessing the Treatment Effects

How do you know if the treatment is working? Most people with non-24 experience cycles of insomnia and excessive daytime sleepiness. These symptoms may shift in timing (and intensity) over weeks to months. This circadian disorder can profoundly impact the ability to function on a regular schedule, affecting work performance, cognitive function (concentration, attention, and short-term memory), and even mood (causing depression, anxiety, or irritability). If treatment is effective, it would be expected that the baseline symptoms should resolve.

Beyond symptomatic improvement, it can be helpful to track the treatment’s effectiveness in other objective ways. Sleep logs and laboratory measurements of circadian phase markers, such as the measurement of melatonin levels in saliva, can be useful.

Importantly, in people with non-24 who are not totally blind, timed light exposure may be a helpful adjunctive therapy. This can be achieved with sunlight exposure or the use of a lightbox. Depending on the nature of the circadian dysfunction, when this light exposure optimally occurs may vary somewhat. As such, input from a sleep specialist is recommended.

A Word From Verywell

Hopefully, further research will make direct comparisons between Hetlioz and melatonin. This research would give us the best understanding of how effective the medication is. It may also be possible to learn who is the best candidate to use Hetlioz, and who may benefit more from melatonin use. In the meanwhile, you may consider discussing the treatment options for non-24 with your board-certified sleep specialist to determine the best option for you.

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