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Lunesta
" •'Heszopiclone)c
1.2 AND 3 MG TABLETS
Please read this summary of information about LUNESTA
before you talk to your doctor or start using LUNESTA. It is
not meant to take the place of your doctor's instructions If
you have any questions about LUNESTA tablets, be sure to
ask vour doctor or pharmacist
LUNESTA is used to treat different types of sleep problems,
such as difficulty in falling asleep, difficulty in maintaining
sleep during the nighl and waking up too early in the morning.
Most people with insomnia have more than one of these
problems. You should take LUNESTA immediately before
going to bed because of the risk of falling.
LUNESTA belongs to a group of medicines known as “hypnotics"
or. simply, sleep medicines There are many different sleep
medicines available to help people sleep better. Insomnia is
often transient and intermittent. It usually requires treatment
for only a short time, usually 7to 10 days up to 2 weeks. If your
insomnia does not improve after 7 to 10 days of treatment,
see your doctor, because it may be a sign of an underlying
condition. Some people have chronic sleep problems that
may require more prolonged use of sleep medicine.
However, you should not use these medicines for long periods
without talking with your doctor about the risks and benefits
of prolonged use.
Side Effects
All medicines have side effects. The most common side
effects of sleep medicines are:
• Drowsiness
• Dizziness
• Lightheadedness
• Difficulty with coordination
Sleep medicines can make you sleepy during the day. How
drowsy you feel depends upon how your body reacts to the
medicine, which sleep medicine you are taking, and how
large a dose your doctor has prescribed Daytime drowsiness
is best avoided by taking the lowest dose possible that will
still help you sleep at night Your doctor will work with you
to find the dose of LUNESTA that is best for you Some
people taking LUNESTA have reported next-day sleepiness.
To manage these side effects while you are taking this medicine:
• When you first start taking LUNESTA or any other
sleep medicine, until you know whether the medicine
will still have some effect on you the next day. use
extreme care while doing anything that requires
complete alertness, such as driving a car, operating
machinery, or piloting an aircraft.
• Do not drink alcohol when you are taking LUNESTA or
any sleep medicine. Alcohol can increase the side
effects of LUNESTA or any other sleep medicine.
• Do not take any other medicines without asking your
doctor first. This includes medicines you can buy
without a prescription. Some medicines can cause
drowsiness and are best avoided while taking LUNESTA.
• Always take the exact dose of LUNESTA prescribed by
your doctor Never change your dose without talking
to your doctor first.
Special Concerns
There are some special problems that may occur while taking
sleep medicines.
Memory Problems
Sleep medicines may cause a special type ot memory loss or
“amnesia." When this occurs, a person may not remember
what has happened for several hours after taking the medicine.
This is usually not a problem since most people fall asleep
after taking the medicine. Memory loss can be a problem,
however, when sleep medicines are taken while traveling, such
as during an airplane flight and the person wakes up before
the effect of the medicine is gone This has been called
“travelers amnesia." Memory problems have been
reported rarely by patients taking LUNESTA in clinical
studies. In most cases, memory problems can be avoided if
you take LUNESTA only when you are able to get a full night
of sleep before you need to be active again. Be sure to talk
to your doctor if you think you are having memory problems.
Tolerance
When sleep medicines are used every night for more than a
few weeks, they may lose their effectiveness in helping you
sleep. This is known as Tolerance." Development of tolerance
to LUNESTA was not observed in a clinical study of
6 months duration. Insomnia is often transient and
intermittent, and prolonged use of sleep medicines is generally
not necessary. Some people, though, have chronic sleep
problems that may require more prolonged use of sleep
medicine. If your sleep problems conbnue. consult your doctor,
who will determine whether other measures are needed to
overcome your sleep problems.
Dependence
Sleep medicines can cause dependence in some people,
especially when these medicines are used regularly for
longer than a few weeks or at high doses. Dependence is
the need to continue taking a medicine because stopping it
is unpleasant.
When people develop dependence, stopping the medicine
suddenly may cause unpleasant symptoms (see Withdrawal
below). They may find they have to keep taking the medicine
either at the prescribed dose or at increasing doses just to
avoid withdrawal symptoms.
All people taking sleep medicines have some risk of becoming
dependent on the medicine. However, people who have been
dependent on alcohol or other drugs in the past may have a
higher chance of becoming addicted to sleep medicines. This
possibility must be considered before using these medicines
for more than a few weeks If you have been addicted to
alcohol or drugs in the past, it is important to tell your
doctor before starting LUNESTA or any sleep medicine
Withdrawal
Withdrawal symptoms may occur when sleep medicines are
stopped suddenly after being used daily for a long time. In
some cases, these symptoms can occur even if the medicine has
been used for only a week or two. In mild cases, withdrawal
symptams may include unpleasant feelings. In more severe
cases, abdominal and muscle cramps, vomiting, sweating,
shakiness, and, rarely, seizures may occur. These more
severe withdrawal symptoms are very uncommon. Although
withdrawal symptoms have not been observed in the
relatively limited controlled trials experience with LUNESTA.
there is. nevertheless, the risk of such events in association
with the use of any sleep medicine.
Another problem that may occur when sleep medicines are
stopped is known as “rebound insomnia." This means that a
person may have more trouble sleeping the first few nights
after the medicine is stopped than before starting the medicine.
If you should experience rebound insomnia, do not get
discouraged. This problem usually goes away on its own
after 1 or 2 nights.
If you have been taking LUNESTA or any other sleep medicine
for more than 1 or 2 weeks, do not stop taking it on your
own. Always follow your doctor’s directions.
Changes In Behavior And Thinking
Some people using sleep medicines have experienced
unusual changes in their thinking and/or behavior. These
effects are not common. However, they have included:
• More outgoing or aggressive behavior than normal
• Confusion
• Strange behavior
• Agitation
• Hallucinations
• Worsening of depression
• Suicidal thoughts
How often these effects occur depends on several factors,
such as a person's general health, the use of other medicines,
and which sleep medicine is being used. Clinical experience
with LUNESTA suggests that it is rarely associated with
these behavior changes.
It is also important to realize it is rarely clear whether these
behavior changes are caused by the medicine, are caused by
an illness, or have occurred on their own. In fact, sleep problems
that do not improve may be due to illnesses that were present
before the medicine was used. If you or your family notice
any changes in your behavior, or it you have any unusual or
disturbing thoughts, call your doctor immediately.
Pregnancy And Breastfeeding
Sleep medicines may cause sedation or other potential
effects in the unborn baby when used during the last weeks
ot pregnancy Be sure to tell your doctor if you are pregnant,
if you are planning to become pregnant, or if you become
pregnant while taking LUNESTA
In addition, a very small amount of LUNESTA may be present
in breast milk after use of the medication. The effects of very
small amounts ot LUNESTA on an infant are not known:
therefore, as with all other prescription sleep medicines, it is
recommended that you not take LUNESTA if you are breast
feeding a baby.
Safe Use Of Sleep Medicines
To ensure the safe and effective use of LUNESTA or any other
sleep medicine, you should observe the following cautions:
1. LUNESTA is a prescription medicine and should be
used ONLY as directed by your doctor. Follow your
doctor's instructions about how to take, when to take,
and how long to take LUNESTA.
2. Never use LUNESTA or any other sleep medicine for
longer than directed by your doctor.
3. If you notice any unusual and/or disturbing thoughts
or behavior during treatment with LUNESTA or any
other sleep medicine, contact your doctor.
4. Tell your doctor about any medicines you may be
taking, including medicines you may buy without a
prescription and herbal preparations. You should also
tell your doctor if you drink alcohol. DO NOT use alcohol
while taking LUNESTA or any other sleep medicine.
5. Do not take LUNESTA unless you are able to get 8 or
more hours of sleep before you must be active again.
6 Do not increase the prescribed dose of LUNESTA or
any other sleep medicine unless instructed by your
doctor
7. When you first start taking LUNESTA or any other
sleep medicine, until ynu know whether the medicine
will still have some effect on you the next day. use
extreme care while doing anything that requires
complete alertness, such as driving a car, operating
machinery, or piloting an aircraft.
8 Be aware that you may have more sleeping problems
the first night or two after stopping any sleep medicine.
9. Be sure to tell your doctor if you are pregnant, if
you are planning to become pregnant, if you become
pregnant, or if you are breastfeeding a baby while
taking LUNESTA
10. As with all prescription medicines, never share
LUNESTA or any other sleep medicine with anyone
else. Always store LUNESTA or any other sleep medicine
in the original container and out of reach of children.
11. Be sure to tell your doctor if you suffer from depression.
12. LUNESTA works very quickly. You should only take
LUNESTA immediately before going to bed.
13. For LUNESTA to work best, you should not take it with
or immediately after a high-fat, heavy meal.
14. Some people, such as older adults (i.e., ages 65 and
over) and people with liver disease, should start with
the lower dose (1 mg) of LUNESTA. Your doctor may
choose to start therapy at 2 mg. In general, adults
under age 65 should be treated with 2 or 3 mg.
15. Each tablet is a single dose: do not crush or break
the tablet.
Note: This summary provides important information about
LUNESTA. It you would like more information, ask your
doctor or pharmacist to let you read the Prescribing
Information and then discuss it with him or her.
Rx only
§ SEPRACOR
© 2005 SEPRACOR INC. All Rights Reserved.
STHIH6S
YOU NEED TO KNOW ABOUT
© SEASONAL
AFFECTIVE
DISORDER
1. Shorter, darker days can cause winter
depression, aka seasonal affective disor
der (SAD). The “season” runs from
about November through early spring
in North America. Symptoms include
fatigue, weight gain (as much as 30
pounds!) and a weakened immune sys
tem. About 10 million Americans are
significantly affected.
2. Know the causes. Lack of light dur
ing waking hours is the root. “Your
body’s rhythm and rate of endorphin
production are inter
rupted,” says Carl
Bell, M.D., president
of the Community
Mental Health Coun
cil. The added stress
of upcoming holi
days and inclement
weather can snow
ball. “Try not to take
on major projects when you know you
aren’t your best self,” says Norman
Rosenthal, M.D., author of Wilder Blues.
3. Demographics matter. SAD is more
likely to affect women (75% of sufferers)
and those ages 18 to 40. People who live in
areas with drastic climate change have
increased vulnerability. And it’s genetic.
“Part of the problem is that it’s both
nature and nurture,” Bell says.
4. Help yourself. Phototherapy the
use of light boxes and dawn simulators
is effective in up to 85% of diagnosed
cases. “Sometimes natural light just
doesn’t cut it,” Rosenthal says. Patients
can eat, work and read while they sit
under rays that are up to 20 times
stronger than a light bulb.
5. Get outdoors. A Swiss study found
that in milder SAD cases, an hour-long
walk in winter sunlight could be as effec
tive at raising spirits as spending 2/
hours under bright indoor lights, ca
Ladan Nekoomaram
12
USA WEEKEND • Nov. 2-4,2007
Lack of light
during waking
hours from
now until
early spring
is the culprit