Drug info - Sedative (Zolpidem) blamed in sleep-driving cases

[Lunar Loops]

This from The Observer (UK):
Sedative blamed in sleep-driving cases


Denis Campbell, social affairs correspondent
Sunday February 4, 2007
The Observer


One of Britain's most popular sleeping drugs has been blamed for a series of bizarre events in which patients have driven their cars or had eating binges in the middle of the night while still unconscious.
New evidence has linked zolpidem to a series of incidents of strange and often risky behaviour, including a woman who painted her front door while still asleep and another user who put on just under four stone in seven months after she began raiding her fridge.

The research, by Australia's Federal Health Department, found 16 cases of odd sleepwalking, 104 of hallucinations and 62 of amnesia among users of the powerful sedative.
Britain's official medicines watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA), said this weekend that it had recorded 68 incidents of adverse reactions to zolpidem between 2001 and 2005 under its 'yellow card' scheme, which doctors use to alert the agency to patients suffering worrying side-effects to a drug.
Twenty-one involved 'psychiatric disorders', 13 were of 'nervous system disorders' and eight involved 'injury, poisoning and procedural' issues.
Problems involving zolpidem have also emerged in America, where some people have been injured by cars driven by people under the influence of the drug, known there as Ambien.
In one high-profile case last year, Representative Patrick Kennedy, son of veteran senator Edward Kennedy, crashed his car into a traffic barrier on Capitol Hill at 3am. He told police that he had been going to vote at the House of Representatives. Kennedy said that he had been taking Ambien and another drug, and had become 'disorientated from the medication'.
In another case, Sean Joyce, a British painting contractor, caused havoc on a flight from North Carolina to London after taking an Ambien pill and two glasses of wine. His behaviour caused the flight to be diverted to Boston and he was later jailed for five days.
Health experts last night voiced alarm about zolpidem, which was prescribed 674,500 times in 2005 in Britain. Of those, 46,800 were for Stilnoct, the name for one of the six versions of zolpidem available in the UK and the drug implicated in the 182 episodes reported on by Australia's Adverse Drug Reactions Advisory Committee.
Professor Mayur Lakhani, chairman of the Royal College of General Practitioners, said: 'I'm concerned to hear about these instances in Australia and the 68 yellow card flaggings by our MHRA, especially as there's an increasing use of hypnotic drugs in this country. It's not the sort of thing you can ignore. We need to be vigilant, to monitor things closely and be careful how we prescribe and take this whole class of drugs.
'GPs should think carefully before they prescribe anything like this, and prescribe it for as short a time as possible, as the guidelines say. The trouble is that there are few alternative treatments for insomnia.'
Labour MP Howard Stoate, who is also a GP in Kent and the only practising GP in the Commons, said: 'I have heard of this problem with zolpidem. It's a matter of great concern. If people are operating machinery, or driving their cars, or doing skilled jobs, you wouldn't want them to be under the influence of anything that would alter their mental state, as drugs such as this do. That could be catastrophic.'
Stoate, a member of the Commons Health Select Committee, added: 'A common impression of sleeping medications is that these things are fairly mild and fairly harmless, and that's a mistake. These drugs all have problems.'
Vanessa Bourne, a spokesman for the Patients Association, said: 'Many of us are only alive because of modern drugs, so it is vital that patients have confidence not just in the drugs themselves, but in the regulatory systems that govern their use.'
An MHRA spokesman said that, as the accompanying information leaflet for both prescribers and users of Stilnoct already warns of possible side-effects including nightmares, night restlessness, sleepwalking, hallucinations and other problems, it was not necessary to conduct any inquiry into the drug or the advice that goes with it. Drug giant Sanofi Aventis, which makes Stilnoct, said it had not been proved in the Australian cases that the drug was causing the incidents of disturbed sleep behaviour.

[~lostgurl~]

SWIM has talked to a few people online who have suffered from SRED (Sleep Related Eating Disorder) from long term use of Ambien. SWIM has also experienced it while taking Zopiclone, though there doesn't seem to be any research for this happening with Zopiclone. For SWIM it also occured after long term use and high doses set it off. Amitriptyline also worsened this condition, and while on Zopiclone and Amitriptyline SWIM was cooking and smoking in her sleep too, she also found her front door wide open one morning. There is a news clip in the file archive about SRED and Ambien: http://www.drugs-forum.com/forum/loc...=1253&catid=39

[Abrad]

www.sfgate.com
All prescription sleeping pills may sometimes cause sleep-driving, federal health officials warned Wednesday, almost a year after the bizarre side effect first made headlines when Rep. Patrick Kennedy crashed his car after taking Ambien.

It's a more complicated version of sleepwalking, but behind the wheel: getting up in the middle of the night and going for a drive — with no memory of doing so.

The Food and Drug Administration wouldn't say exactly how many cases of sleep-driving it had linked to insomnia drugs, but neurology chief Dr. Russell Katz said the agency uncovered more than a dozen reports — and is worried that more are going uncounted.

Given the millions of prescriptions for insomnia drugs, Katz called the problem rare, and said he was unaware of any deaths. But because sleep-driving is so dangerous — and there are precautions that patients can take — the FDA ordered a series of strict new steps Wednesday.

First, the makers of 13 sleep drugs must put warnings on their labels about two rare but serious side effects:

_sleep-driving, along with other less dangerous "complex sleep-related behaviors" — like making phone calls, fixing and eating food, and having sex while still asleep.

_and life-threatening allergic reactions, as well as severe facial swelling, both of which can occur either the first time the pills are taken or anytime thereafter.

Next, doctors this week will begin getting letters notifying them of the new warnings.

Later this year, all prescription sleeping pills will begin coming with special brochures called "Medication Guides" that spell out the risks for patients in easy-to-understand language.

Sleep-driving made headlines last May when Kennedy, D-R.I., crashed his car into a security barrier outside the U.S. Capitol after taking Ambien and a second drug, Phenergan, an anti-nausea pill that also acts as a sedative. Kennedy has said he had no memory of the event. He pleaded guilty to driving under the influence of prescription drugs, and was sentenced to court-ordered drug treatment and a year's probation.

Ambien isn't the only insomnia drug that can cause sleep-driving — any of the class known as "sedative-hypnotics" can, FDA's Katz stressed Wednesday.

To lower the risk of a sleep-driving episode, he advised patients to never take any prescription insomnia drug along with alcohol or any other sedating drug. Also, don't take higher-than-recommended doses of the pills.

"We really want people to know these things can occur, and these sleep behaviors can be perhaps to a large extent mitigated by behaviors the patients can control," he said.

Some of the insomnia drugs may be riskier than others, so FDA also recommended that manufacturers conduct clinical trials to figure that out.

The drugs are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; Sonata.

Fewer than one in 1,000 patients in studies of Ambien reported somnambulism — a scientific term that includes the sleep behaviors flagged by the FDA — said Lisa Kennedy, a spokeswoman for manufacturer Sanofi-Aventis SA, who is not related to the congressman. The side effect has remained similarly rare since widespread sales began, she said.