New evidence has linked a commonly prescribedsleep medication with bizarre behaviours, including acase in which a woman painted her front door in hersleep.
UK and Australian health agencies have released information about 240 cases of oddoccurrences, including sleepwalking, amnesia and hallucinations among people taking the drugzolpidem.
While doctors say that zolpidem can offer much-needed relief for people with sleepdisorders, they caution that these newly reported cases should prompt a closer look at itspossible side effects.
Zolpidem, sold under the brand names Ambien, Stilnoct and Stilnox, is widely prescribed totreat insomnia and other disorders such as sleep apnea. Various forms of the drug, made byFrench 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 ofhallucinations and 62 cases of amnesia experienced by people taking zolpidem since marketingof the drug began there in 2000. The health department report also mentioned 16 cases ofstrangesleepwalking by people taking the medication.
Midnight snack
In one of these sleepwalking cases a patient woke with a paintbrush in her hand afterpainting the front door to her house. Another case involved a woman who gained 23 kilogramsover seven months while taking zolpidem. "It was only when she was discovered in front of anopen refrigerator while asleep that the problem was resolved," according to the report.
The UK's Medicines and Healthcare products Regulatory Agency, meanwhile, has recorded68 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 bizarresleepwalking 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 apassenger caused havoc after taking zolpidem.
Hypnotic effects
There is no biological pathway that has been proven to connect zolpidem with thesebehaviours. The drug is a benzodiazepine-like hypnotic that promotes deep sleep by interactingwith brain receptors for a chemical called gamma-aminobutyric acid. While parts of the brainbecome less active during deep sleep, the body can still move, making sleepwalking a possibility.
The product information for prescribers advises that psychiatric adverse effects, includinghallucinations, sleepwalking and nightmares, are more likely in the elderly, and treatment shouldbe stopped if they occur.
Patient advocacy groups say they would like government health agencies and drugcompanies to take a closer look at the possible risks associated with sleep medicines. Theystress 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," saysVera Sharav of the New York-based Alliance for Human Research Protection, a US network thatadvocates responsible and ethical medical research practices.
Tried and tested
"The more reports that come out about the potential side effects of the drug, the moreresearch needs to be done to understand if these are real side effects," says sleep researcherKenneth Wright at the University of Colorado in Boulder, US.
Millions of people have taken the drug without experiencing any strange side effects, pointsout Richard Millman at Brown Medical School, director of the Sleep Disorders Center of LifespanHospitals 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 beeasily explained: some patients have wrongly taken the drug right before leaving work in hopesthat the medicine will kick in by the time they reach home. Doctors stress that the medicationshould be taken just before going to bed.
The US Food & Drug Administration says it is continuing to "actively investigate" andcollect information about cases linking zolpidem to unusual side effects.
The Ambien label currently lists strange behaviour as a "special concern" for people takingthe drug. "It's a possible rare adverse event," says Sanofi-Aventis spokesperson MelissaFeltmann, adding that the strange sleepwalking behaviours "may not necessarily be caused bythe drug" but instead result from an underlying disorder. She says that "the safety profile [ofzolpidem] is well established". The drug received approval in the US in 1993.
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Questions 1-6 Do the following statements agreewith the information given in the reading passage?
In boxes 1-6 on your answer sheet write
TRUE if the statement is true according to thepassage
FALSE if the statement is false according to thepassage
NOT GIVEN if the information is not given in thepassage
1. Ambien, Stilnoct and Stilnox are brand namesof 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 ofa 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 officeworker.
Question 7-9 Choose the appropriate letters A-D and Write them in boxes 7-9 on youranswer 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 WORDSeach 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 patientadvocacy groups?
13. What US administration says that it has been investigating the cases relating zolpidemto unusual side effects?
Answer keys and explanations:
1. True
See para.3 from the beginning: Zolpidem, soldunder the brand names Ambien, Stilnoct andStilnox, is widely prescribed to treat insomnia andother disorders such as sleep apnea.
2. False
See para.1 under the subtitle "Midnight snack":Another case involved a woman who gained 23kilograms over seven months while taking zolpidem. "It was only when she was discovered in front of anopen 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 productsRegulatory Agency, meanwhile, has recorded 68 cases of adverse reactions to zolpidem from2001 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 bediverted 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 sleepmedications, 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 thereports of "sleep-driving" linked to zolpidem can be easily explained: some patients havewrongly taken the drug right before leaving work in hopes that the medicine will kick in by thetime 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 HealthDepartment describes 104 cases of hallucinations and 62 cases of amnesia experienced bypeople taking zolpidem since marketing of the drug began there in 2000. The health departmentreport 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 informationfor prescribers advises that psychiatric adverse effects, including hallucinations, sleepwalkingand 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 productinformation" 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 MelissaFeltmann … 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 pharmaceuticalgiant Sanofi-Aventis, were prescribed 674,500 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 chemicalcalled gamma-aminobutyric acid.
12. risky consequences
See para.3 under the subtitle "Hypnotic effects": Patient advocacy groups … stress thatstrange 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 Administrationsays it is continuing to "actively investigate" and collect information about cases linkingzolpidem to unusual side effects.