People who take the insomnia treatment melatonin long-term have double the risk of heart failure, according to a recent study.
Previous research has found that melatonin does not even work well as a sleep aid. Other medicines are more effective for insomnia, but are discouraged apart from as a stopgap measure because people can become dependent on them.
So, what do doctors recommend for insomnia?
Insomnia is one of the commonest health problems, with one in 10 people having difficulties getting off to sleep either at the start of the night or after waking up in the early hours.
Sedating medicines like Valium, a benzodiazepine, were once the mainstay of treatment but are now used less because of their high potential for causing addiction.
More recently, doctors have turned to allergy medicines like antihistamines, as these can cause drowsiness as a side effect, or another class of medicines called “Z drugs”. These work by slowing down brain activity.
But even these newer approaches have downsides. They can cause daytime drowsiness, and also lead to tolerance – in other words, people become dependent on taking the medicine to get to sleep. Z drugs also raise the risk of sleep walking, which can be dangerous.
Daily exercise can help avoid sleeping difficulties (Photo: SimpleImages/Getty)Melatonin works in a different way. It is a hormone made by the brain that helps set our sleep-wake cycle. “It’s the hormone that tells your body it’s dark,” said Professor Kevin Morgan, a psychologist at Loughborough University.
“When darkness occurs, special cells in your retina allow the levels of melatonin in your nervous system to increase. The reverse happens during daylight hours.”
In the UK, melatonin is available on prescription, and should be taken one to two hours before bedtime. It is typically prescribed for jet lag, for older people and for children with sleep problems caused by autism.
Melatonin tablets are surprisingly popular. They can be bought in the US as an over-the-counter supplement, and their use there has soared, with about 2 per cent of Americans using them. Visiting Brits may also buy large jars of the tablets to bring home.
Melatonin ‘surprisingly ineffective’
Despite its popularity, placebo-controlled trials found that melatonin does not work that well. One review showed it increases time spent asleep by just eight minutes and speeds up sleep onset by seven minutes.
The scientists who carried out that analysis concluded that melatonin could still be useful as it had less risk of causing dependence than traditional sleeping pills.
“Although the absolute benefit of melatonin compared to placebo is smaller than other treatments, melatonin may have a role in the treatment of insomnia given its relatively benign side-effect profile,” they said in their paper.
But is it time to rethink melatonin’s benign image? The new study analysed five years of health records for more than 130,000 people with insomnia.
They found that people who had used melatonin for a year or more had nearly twice the risk of developing heart failure, and of dying from any cause. The figures showed 7.8 per cent of melatonin users died over the study period compared with 4.3 per cent of non-users.
“It was striking to see such consistent and significant increases in serious health outcomes, even after balancing for many other risk factors,” said Dr Ekenedilichukwu Nnadi, an internal medicine physician at SUNY Downstate Health Sciences University in New York, who led the study.
The findings were presented at the American Heart Association’s meeting in New Orleans last week.
Dr Nnadi cautioned that because this study was not a randomised trial, the best kind of medical evidence, it could not prove melatonin was causing the deaths – it could just be correlation.
Natural doesn’t always mean safe
Nevertheless, people might need to rethink seeing melatonin as harmless, he said. “[It] is widely thought of as a safe and natural option.”
“It should not be taken chronically without a proper indication,” said Professor Marie-Pierre St-Onge, professor of nutritional medicine at Columbia University Irving Medical Center in New York, who was not involved in the study.
It is likely that fewer people take melatonin in the UK, because of the need for a prescription. But those who do may be overestimating how well it works, said Professor Morgan.
“It helps people whose circadian rhythm and sleep is slightly out of phase to resynchronise their sleep. But if people suppose that it’s a bit like a sleeping drug, that will be a disappointment.”
A new kind of insomnia treatment called daridorexant that has recently become available in the UK is causing interest. This works by suppressing a brain signalling molecule called orexin, which normally helps keep us awake.
But as daridorexant is a new drug, some doctors may be cautious about prescribing it. And as with all insomnia medicines, it is supposed to be used for as short a time as possible.
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Rather than sleeping pills, doctors should be trying to steer patients toward a special form of cognitive behavioural therapy (CBT) designed for insomnia, said Professor Morgan. This involves educating people on how to change sleep habits – including initially restricting sleep to make them fall asleep more quickly at the next night time – as well as relaxation exercises.
Trials have shown that these kinds of techniques benefit 60 to 80 per cent of people who try them. Insomnia CBT can be accessed through the NHS and there are now free apps that provide it, such as Sleepio and Sleepful.
Such approaches are more time-consuming than just taking sleeping tablets, but they avoid starting down a pharmaceutical pathway that might create more problems than it solves, said Professor Morgan.
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