Inpatient Sleeping Drug Quadrupled Fall Risk; May
Boost Risk of Unexpected Sex?
Advancing age causes fall risk to rise rapidly but
this drug increases risk more than aging
Nov. 19, 2012 - A drug commonly prescribed to help
patients sleep in hospitals has been associated with an increased risk
of falls, according to a study published in the Journal of Hospital
Medicine. The Food and Drug Administration warns, too, you may even
have unplanned sex after taking zolpidem (see box below).
U.S. sleep specialists from the Mayo Clinic found
that the risk posed by the drug was greater than the risks posed by
factors such as age, cognitive impairment, delirium or insomnia,
regardless of the dosage used.
They report that the fall rate among the 4,962
patients who took zolpidem during their hospital stay was more than four
times as high as the 11,358 who did not take the drug.
"Ensuring that people get enough sleep during their
hospital stay is very important, but it can also prove very
challenging," says the Clinic's Chief Patient Safety Officer Dr. Timothy
I. Morgenthaler, who specializes in sleep disorders and pulmonary and
You May End Up
Having Unplanned Sex After Taking Zolpidem: FDA
The FDA warns that
people taking Zolpidem may end up doing some unintended things –
like having sex. Here is what they warn:
“What is the most
important information I should know about Zolpidem Tartrate
"After taking Zolpidem
Tartrate Tablets, you may get up out of bed while not being
fully awake and do an activity that you do not know you are
doing. The next morning, you may not remember that you did
anything during the night. You have a higher chance for doing
these activities if you drink alcohol or take other medicines
that make you sleepy with Zolpidem Tartrate Tablets. Reported
● driving a car
● making and eating
● talking on the phone
● having sex
"Call your doctor right
away if you find out that you have done any of the above
activities after taking Zolpidem Tartrate Tablets.”
"Patient falls are also a significant patient
safety issue in hospitals and one that has been quite difficult to
tackle, despite considerable efforts. That is why it is one of the
target aims of the U.S. Department of Health and Human Services
Partnership for Patients project."
"Discovering that zolpidem, which is commonly used
in hospitals, is a significant risk factor for patient falls provides us
with additional knowledge to help tackle this problem."
Key findings of the study include:
● Just under 39 percent of eligible admissions
during 2010 were prescribed zolpidem (16,320 patients) but 88 percent of
the prescriptions were issued on an "as needed basis."
● Zolpidem was administered to 30.4 percent of
patients who were prescribed it and to 11.8 percent of all Mayo Clinic
admissions in 2010.
● Just over three percent of the patients on
zolpidem fell during their in-patient hospital stay, compared with 0.7
percent of the patients who did not take zolpidem.
● Zolipdem use continued to be associated with
an increased fall risk when other key factors, including health, length
of hospital stay and assessed fall risk, were taken into consideration.
"Our hospitals have an overall fall rate of about
2.5 per 1000 patient days, which is lower than many national benchmarks.
"However, we have not been able to significantly
reduce this rate in recent years. Now, we calculate that for every 55
patients who received zolpidem, there was one additional fall that may
have been avoided by not administering the drug," says Dr. Morgenthaler.
"As a result of our study, we are now phasing out
zolpidem and moving toward sleep enhancement techniques that are not
based on drugs and which we believe are safer and probably as
About Zolpidem by
National Library of Medicine
pi dem )
Why is this medication prescribed?
Zolpidem is used to treat insomnia (difficulty
falling asleep or staying asleep). Zolpidem belongs to a class of
medications called sedative-hypnotics. It works by slowing activity in
the brain to allow sleep.
Zolpidem comes as a tablet (Ambien) and an
extended-release (long-acting) tablet (Ambien CR) to take by mouth.
Zolpidem also comes as a sublingual tablet (Edluar, Intermezzo) to place
under the tongue and an oral spray (Zolpimist) which is sprayed into the
mouth over the tongue.
If you are taking the tablets, extended-release
tablets, sublingual tablets (Edluar), or oral spray, you will take the
medication as needed, not more than one time a day, immediately before
bedtime. If you are taking the sublingual tablets (Intermezzo), you will
take the medication as needed, not more than one time during the night
if you wake up and have difficulty returning to sleep. Zolpidem will
work faster if it is not taken with a meal or immediately after a meal.
Follow the directions on your prescription label carefully, and ask your
doctor or pharmacist to explain any part you do not understand. Use zolpidem exactly as directed.
You will probably become very sleepy soon after you
take zolpidem and will remain sleepy for some time after you take the
medication. Plan to go to bed right after you take zolpidem tablets,
extended-release tablets, sublingual tablets (Edluar), and oral spray
and to stay in bed for 7 to 8 hours.
Take zolpidem sublingual tablets
(Intermezzo) only when you are already in bed and can remain in bed for
at least 4 more hours. Do not take zolpidem if you will be unable to
remain asleep for the required number of hours after taking the
medication. If you get up too soon after taking zolpidem, you may
experience memory problems.
Swallow the extended release tablets whole; do not
split, chew, or crush them. Tell your doctor or pharmacist if you cannot
Do not open the pouch that contains the blister
pack of the sublingual tablet (Intermezzo) until you are ready to take
the tablet. To remove the sublingual tablet (Edluar) from the blister
pack, peel off the top layer of paper and push the tablet through the
foil. To take either brand of sublingual tablet, place the tablet under
your tongue, and wait for it to dissolve. Do not swallow the tablet or
take the tablet with water.
To use the oral spray, follow these directions and
those that appear in the package label:
Before using zolpidem spray for the first time, or
if you have not used the spray bottle for 14 days, you must prime the
Line up the arrows on the cap and the base of the
container. Squeeze the cap at the arrows and pull the cap and base apart
to separate. Remove the clear protective cap from the pump.
To prime the pump, hold the container upright.
Point the black spray opening away from your face and other people.
Press down on the pump with your forefinger, release and let it return
to the starting position and repeat 4 more times. You should see a fine
spray come out of the container.
To use zolpidem spray, hold the container upright
with the black spray opening pointed directly into your mouth, over the
top of your tongue. Press down fully on the pump to make sure that a
full dose of zolpidem is sprayed.
Let the pump return to the starting position. If
your doctor prescribed only one spray of zolpidem, put the clear
protective cap back over the pump at the top of the base after each use.
If your doctor has prescribed two sprays of zolpidem for your dose, a
second spray should be used.
Snap the child-resistant cap back onto the base and
rotate the cap and base so that the arrows are not lined up. This is to
help prevent a child from using the spray mist bottle.
Your sleep problems should improve within 7 to 10
days after you start taking zolpidem. Call your doctor if your sleep
problems do not improve during this time or if they get worse at any
time during your treatment.
Zolpidem should normally be taken for short periods
of time. If you take zolpidem for 2 weeks or longer, zolpidem may not
help you sleep as well as it did when you first began to take the
medication. If you take zolpidem for a long time, you also may develop
dependence ('addiction,' a need to continue taking the medication) on
zolpidem. Talk to your doctor about the risks of taking zolpidem for 2
weeks or longer. Do not take a larger dose of zolpidem, take it more
often, or take it for a longer time than prescribed by your doctor.
Do not stop taking zolpidem without talking to your
doctor, especially if you have taken it for longer than 2 weeks. If you
suddenly stop taking zolpidem, you may develop unpleasant feelings or
mood changes or you may experience other withdrawal symptoms such as
shakiness, lightheadedness, stomach and muscle cramps, nausea, vomiting,
sweating, flushing, tiredness, uncontrollable crying, nervousness, panic
attack, difficulty falling asleep or staying asleep, uncontrollable
shaking of a part of your body, and rarely, seizures.
You may have more difficulty falling asleep or
staying asleep on the first night after you stop taking zolpidem than
you did before you started taking the medication. This is normal and
usually gets better without treatment after one or two nights.
Your doctor or pharmacist will give you the
manufacturer's patient information sheet (Medication Guide) when you
begin treatment with zolpidem and each time you refill your
prescription. Read the information carefully and ask your doctor or
pharmacist if you have any questions. You can also visit the Food and
Drug Administration (FDA) website (http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089833.pdf)
or the manufacturer's website to obtain the Medication Guide.