OTC Melatonin Improves Sleep Quality in MS Patients, Trial Finds

Taking the hormone melatonin may increase overall sleep quality in people with multiple sclerosis (MS), a clinical trial found.

The compound, available as an over-the-counter dietary supplement, was particularly effective at extending sleep time in patients. Of note, sleep time decreased with age, meaning that “younger participants may have a better response to the use of melatonin to improve sleep,” the researchers wrote.

Furthermore, the study showed that measures of fatigue — which has been associated with poor sleep — also were “nominally improved (though these results were neither statistically nor clinically significant).”

According to the researchers, “larger studies are needed to unravel the complex relationship between MS and sleep disturbances,” especially concerning both fatigue and daytime sleepiness.

“Since fatigue is a primary determinant of poor QoL [quality of life] and may worsen cognitive domains such as information processing, memory and attention, relief of fatigue could help [people with] MS to reduce the profound impacts of fatigue on their social and professional capabilities as well as their QoL,” the researchers wrote.

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The study, “Effects of melatonin on sleep disturbances in multiple sclerosis: A randomized, controlled pilot study,” was published in Multiple Sclerosis Journal – Experimental, Translational and Clinical.

About half of people living with MS have trouble sleeping. Lack of restful sleep can make symptoms worse and increase both daytime sleepiness and fatigue, which can affect overall well-being. However, the best way to manage sleep problems in people with MS is unclear.

Melatonin is a hormone that helps control the body’s sleep/wake cycle. It is made naturally in the brain in response to darkness but can also be produced in a lab and sold as a dietary supplement.

People with MS make lower levels of melatonin than others of the same age, which might be linked with the greater time to fall asleep and overall lower sleep quality in patients.

Melatonin is frequently used by healthy individuals and those with neurologic diseases to improve sleep quality and ease jet lag, but no studies have evaluated supplement melatonin as a way to reduce sleep problems in people with MS.

To address that, a team of researchers in the U.S. conducted a clinical trial (NCT04035889) involving 30 adults with MS who reported sleep difficulties. Their mean age was 46.7, and they had been diagnosed a mean of 9.7 years earlier.

Participants were randomly assigned to receive melatonin or a placebo for two weeks, after which they switched to the opposite treatment for another two weeks. They were instructed to start with 0.5 mg of melatonin, or one pill every night, for three days, and to increase the dose to 3 mg if no changes in sleep were noted.

Both the melatonin and placebo were given in the form of white, peppermint-flavored mints, and both patients and researchers were unaware of the treatment being given.

During weeks two and four, all patients wore an actigraph — a small device worn like a watch on the wrist — to record the amount and quality of sleep. However, two patients in each group failed to wear the device correctly, and were excluded from the analysis. Two other patients encountered technical issues with recording.

As part of the study, the participants also were asked to complete a sleep diary online. In it, they reported their sleep quality, daytime sleepiness, fatigue, walking ability, and feelings of anxiety and depression at the beginning of the study, as well as at the end of weeks two and four.

When the researchers looked at differences in total sleep time, they found that people who took melatonin slept a mean 18 minutes longer than those on a placebo (7.0 vs. 6.7 hours), which was close to the clinically significant mark of 20 minutes.

Knowing that the levels of melatonin in the blood typically decrease with age, the researchers searched for a link between age and sleep time. They found that younger people with MS slept the longest, and that sleep time decreased with age.

Moreover, those who took melatonin tended to experience fewer sleep problems, as assessed using the Insomnia Severity Index, and have better sleep quality, as assessed using the Pittsburgh Sleep Quality Index. They also showed a trend toward less fatigue than those on a placebo, although those differences were not significant.

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Daytime sleepiness, the number of walking steps, and feelings of anxiety and depression were not different between those on melatonin versus the placebo.

There were no side effects related to the use of melatonin.

“Melatonin use was associated with greater total sleep time; furthermore, sleep efficiency and self-reported sleep measures, including sleep quality, sleep disturbances and fatigue, were also nominally improved,” the researchers wrote.

Regarding fatigue, the team wrote that “subjective fatigue without sleepiness is frequently reported by individuals complaining of poor sleep.” Given that, they suggest that “it is possible that melatonin mitigates symptoms of fatigue, with limited effects on daytime sleepiness.”

Since people with sleep problems are at greater risk for heart diseases, obesity, and diabetes, the researchers say their findings suggest that sleep disturbances “should be routinely evaluated in standard MS care.”

“Sleep disorders are under-recognized and under-treated in this population,” the team wrote, saying that measures should be taken “to improve sleep and possibly reduce long-term health consequences caused by poor sleep.”