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　　Sleep medication linked to bizarre behaviour

　　12:44 06 February 2007

　　NewScientist.com news service

　　Roxanne Khamsi

　　New evidence has linked a commonly prescribed sleep medication with bizarre
behaviours, including a case in which a woman painted her front door in her
sleep.

　　UK and Australian health agencies have released information about 240 cases
of odd occurrences, including sleepwalking, amnesia and hallucinations among
people taking the drug zolpidem.

　　While doctors say that zolpidem can offer much-needed relief for people
with sleep disorders, they caution that these newly reported cases should prompt
a closer look at its possible side effects.

　　Zolpidem, sold under the brand names Ambien, Stilnoct and Stilnox, is
widely prescribed to treat insomnia and other disorders such as sleep apnea.
Various forms of the drug, made by French pharmaceutical giant Sanofi-Aventis,
were prescribed 674,500 times in 2005 in the UK.

　　A newly published report from Australia’s Federal Health Department
describes 104 cases of hallucinations and 62 cases of amnesia experienced by
people taking zolpidem since marketing of the drug began there in 2000. The
health department report also mentioned 16 cases of strange sleepwalking by
people taking the medication.

　　Midnight snack

　　In one of these sleepwalking cases a patient woke with a paintbrush in her
hand after painting the front door to her house. Another case involved a woman
who gained 23 kilograms over seven months while taking zolpidem. “It was only
when she was discovered in front of an open refrigerator while asleep that the
problem was resolved,” according to the report.

　　The UK’s Medicines and Healthcare products Regulatory Agency, meanwhile,
has recorded 68 cases of adverse reactions to zolpidem from 2001 to 2005.

　　The newly reported cases in the UK and Australia add to a growing list of
bizarre sleepwalking episodes linked to the drug in other countries, including
reports of people sleep-driving while on the medication. In one case, a
transatlantic flight had to be diverted after a passenger caused havoc after
taking zolpidem.

　　Hypnotic effects

　　There is no biological pathway that has been proven to connect zolpidem
with these behaviours. The drug is a benzodiazepine-like hypnotic that promotes
deep sleep by interacting with brain receptors for a chemical called
gamma-aminobutyric acid. While parts of the brain become less active during deep
sleep, the body can still move, making sleepwalking a possibility.

　　The product information for prescribers advises that psychiatric adverse
effects, including hallucinations, sleepwalking and nightmares, are more likely
in the elderly, and treatment should be stopped if they occur.

　　Patient advocacy groups say they would like government health agencies and
drug companies to take a closer look at the possible risks associated with sleep
medicines. They stress that strange sleepwalking and sleep-driving behaviours
can have risky consequences.

　　“When people do something in which they’re not in full control it’s always
a danger,” says Vera Sharav of the New York-based Alliance for Human Research
Protection, a US network that advocates responsible and ethical medical research
practices.

　　Tried and tested

　　“The more reports that come out about the potential side effects of the
drug, the more research needs to be done to understand if these are real side
effects,” says sleep researcher Kenneth Wright at the University of Colorado in
Boulder, US.

　　Millions of people have taken the drug without experiencing any strange
side effects, points out Richard Millman at Brown Medical School, director of
the Sleep Disorders Center of Lifespan Hospitals in Providence, Rhode Island,
US. He says that unlike older types of sleep medications, zolpidem does not
carry as great a risk of addiction.

　　And Wright notes that some of the reports of “sleep-driving” linked to
zolpidem can be easily explained: some patients have wrongly taken the drug
right before leaving work in hopes that the medicine will kick in by the time
they reach home. Doctors stress that the medication should be taken just before
going to bed.

　　The US Food & Drug Administration says it is continuing to "actively
investigate" and collect information about cases linking zolpidem to unusual
side effects.

　　The Ambien label currently lists strange behaviour as a “special concern”
for people taking the drug. “It’s a possible rare adverse event,” says
Sanofi-Aventis spokesperson Melissa Feltmann, adding that the strange
sleepwalking behaviours “may not necessarily be caused by the drug” but instead
result from an underlying disorder. She says that “the safety profile [of
zolpidem] is well established”. The drug received approval in the US in
1993.

　　Questions 1-6

　　Do the following statements agree with the information given in the reading
passage?

　　In boxes 1-6 on your answer sheet write

　　TRUE if the statement is true according to the passage

　　FALSE if the statement is false according to the passage

　　NOT GIVEN if the information is not given in the passage

　　1. Ambien, Stilnoct and Stilnox are brand names of one same drug treating
insomnia.

　　2. The woman’s obesity problem wasn’t resolved until she stopped taking
zolpidem.

　　3. Zolpidem received approval in the UK in 2001.

　　4. The bizarre behaviour of a passenger after taking zolpidem resulted in
the diversion of a flight bound for the other side of the Atlantic.

　　5. Zolpidem is the only sleep medication that doesn’t cause addiction.

　　6. The sleep-driving occurrence resulted from the wrong use of zolpidem by
an office worker.

　　Question 7-9

　　Choose the appropriate letters A-D and Write them in boxes 7-9 on your
answer sheet.

　　7. How many cases of bizarre behaviours are described in an official report
from Australia?

　　A. 68

　　B. 104

　　C. 182

　　D. 240

　　8. Which of the following is NOT mentioned in the product information about
zolpidem?

　　A. Treatment should be stopped if side effects occur.

　　B. Medication should be taken just before going to bed.

　　C. Adverse effects are more likely in the elderly.

　　D. Side effects include nightmares, hallucinations and sleepwalking.

　　9. Who claimed that the safety description of zolpidem was well
established?

　　A. Kenneth Wright

　　B. Melissa Feltmann

　　C. Richard Millman

　　D. Vera Sharav

　　Questions 10-13

　　Answer the following questions with NO MORE THAN THREE WORDS each in boxes
10-13.

　　10. How many times was French-made zolpidem prescribed in 2005 in
Britain?

　　11. What kind of hypnotic is zolpidem as a drug which promotes deep sleep
in patients?

　　12. What can sleepwalking and sleep-driving behaviours cause according to
patient advocacy groups?

　　13. What US administration says that it has been investigating the cases
relating zolpidem to unusual side effects?

　　Answer keys and explanations:

　　1. True

　　See para.3 from the beginning: Zolpidem, sold under the brand names Ambien,
Stilnoct and Stilnox, is widely prescribed to treat insomnia and other disorders
such as sleep apnea.

　　2. False

　　See para.1 under the subtitle “Midnight snack”: Another case involved a
woman who gained 23 kilograms over seven months while taking zolpidem. “It was
only when she was discovered in front of an open refrigerator while asleep that
the problem was resolved”…

　　3. Not Given

　　See para.2 under the subtitle “Midnight snack”: The UK’s Medicines and
Healthcare products Regulatory Agency, meanwhile, has recorded 68 cases of
adverse reactions to zolpidem from 2001 to 2005. (The time the drug was approved
in the UK was not mentioned.)

　　4. True

　　See para.3 under the subtitle “Midnight snack”: In one case, a
transatlantic flight had to be diverted after a passenger caused havoc after
taking zolpidem.

　　5. False

　　See para.2 under the subtitle “Tried and tested”: He says that unlike older
types of sleep medications, zolpidem does not carry as great a risk of
addiction.

　　6. Not Given

　　See para.3 under the subtitle “Tried and tested”: And Wright notes that
some of the reports of “sleep-driving” linked to zolpidem can be easily
explained: some patients have wrongly taken the drug right before leaving work
in hopes that the medicine will kick in by the time they reach home. (No
patients as office workers are mentioned in the passage.)

　　7. C

　　See para.4 from the beginning: A newly published report from Australia’s
Federal Health Department describes 104 cases of hallucinations and 62 cases of
amnesia experienced by people taking zolpidem since marketing of the drug began
there in 2000. The health department report also mentioned 16 cases of strange
sleepwalking by people taking the medication.

　　8. B

　　See the sentence in para.2 under the subtitle “Hypnotic effects” (The
product information for prescribers advises that psychiatric adverse effects,
including hallucinations, sleepwalking and nightmares, are more likely in the
elderly, and treatment should be stopped if they occur.) and the sentence in
para.3 under the subtitle “Tried and tested” (Doctors “not the product
information” stress that the medication should be taken just before going to
bed.)

　　9. B

　　See para.5 under the subtitle “Tried and tested”: Sanofi-Aventis
spokesperson Melissa Feltmann … says that “the safety profile [of zolpidem] is
well established”.

　　10. 674,500 (times)

　　See para.3 from the beginning: Various forms of the drug, made by French
pharmaceutical giant Sanofi-Aventis, were prescribed674,500 times in 2005 in the
UK.

　　11. (a) benzodiazepine-like (hypnotic)

　　See para.1 under the subtitle “Hypnotic effects”: The drug is a
benzodiazepine-like hypnotic (类苯二氮催眠药)that promotes deep sleep by interacting
with brain receptors for a chemical called gamma-aminobutyric acid.

　　12. risky consequences

　　See para.3 under the subtitle “Hypnotic effects”: Patient advocacy groups …
stress that strange sleepwalking and sleep-driving behaviours can have risky
consequences.

　　13. Food & Drug (Administration)

　　See para.4 under the subtitle “Tried and tested”: The US Food & Drug
Administration says it is continuing to "actively investigate" and collect
information about cases linking zolpidem to unusual side effects.

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