Prescription sleeping pills must now carry warnings on the boxes, US health officials declare because dozens of people have lost limbs, drowned and even SHOT themselves while sleepwalking after taking them
- US Food and Drug Administration has upgraded the level of warning for the pills
- Its rule change will cover the branded drugs Ambien, Sonata and Lunesta
- It cited 66 reports of people injuring themselves or dying while asleep
- An expert warned the side effects could happen after someone’s first dose
Sleeping pills will now have to show warning labels in the US because people are accidentally killing themselves by walking or driving while asleep.
The Food and Drug Administration this week said certain prescribed insomnia medications will have to carry the cautions.
Drugs including Ambien, Sonata and Lunesta will now have to have boxed warnings – the most severe type of product warning issued by the FDA.
People have been reported to have had car crashes, drowned, shot themselves, or lost limbs to cold after sleepwalking on the drugs.
Ambien, pharmaceutical name zolpidem, must now carry the most severe warning possible in the US because people have injured themselves or died after taking it, the FDA said
The US’s drug regulator announced the requirement this week, reporting 66 incidents in which people hurt themselves or died sleepwalking.
‘While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk, said FDA commissioner Ned Sharpless.
‘These incidents can occur after the first dose of these sleep medicines or after a longer period of treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended doses.’
Out of the 66 cases, 20 of the people died – from carbon monoxide poisoning, drowning, falling, hypothermia, car accidents, or potential suicide, USA Today reported.
IS IT DANGEROUS TO TAKE SLEEPING PILLS EVERY NIGHT?
It is common to use sleeping pills to help you drift off, but they can cause side effects such as grogginess the next day, unusual dreams, weakness or headaches.
But Daily Mail columnist, Dr Martin Scurr explains that, while a useful stopgap, the pills may not be ideal for tackling the cause of sleeping disorders.
He said: ‘The ease with which these sleeping pills are prescribed increases the likelihood of the major problem associated with all of them: dependence.’
‘All of these drugs affect nerve pathways deep in the brain associated with regulating wakefulness,’ he added.
‘The problem is that their effect on brain chemicals – which, in many cases, are not fully understood – means they can lead to dependence and withdrawal symptoms when used for long periods.’
Dr Scurr instead suggests people attend a sleep clinic to get to the root cause of their sleeplessness and try to tackle that in a more sustainable way.
Non-deadly injuries among the other 46 people were accidental overdose, losing limbs to cold, burns, falls and what appeared to be suicide attempts.
Although the drugs’ warnings are already included on patient information labels, the new ruling would require companies to make them more obvious.
The sleeping pills, medical names eszopiclone, zaleplon and zolpidem, are a class of drugs called sedative-hypnotics which are used to treat insomnia.
They are also prescribed in the UK under the names Zolpidem, Ambien and Zopiclone, among others – but the FDA ruling won’t apply to Britain.
They help people fall asleep faster by slowing down activity in the brain, and can prevent them from waking up in the night.
Patients taking them have been warned to immediately stop taking the drugs and tell their doctor if they notice sleepwalking or unusual behaviour after taking them.
Researchers earlier this year revealed millions of people taking sleeping pills may be so out of it at night that they wouldn’t even wake up to the sound of a fire alarm.
Tests on mice showed half of the rodents given a type of benzodiazepines – which include Xanax and Valium – failed to rise to the startling noise.
When comparing the effects of the commonly-used drugs to those of a hypnosis sleeping treatment, the researchers found the mice were more likely to wake up after being hypnotised.
They tested this by trying to wake the mice with a threatening stimulus such as the smell of a fox, a high-pitched dog whistle or someone shaking their cage.