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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.
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'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.
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