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Patient Information Sheet
Zaleplon (marketed as Sonata)
This is a summary of the most important information about Sonata. For details, talk to
your healthcare professional.
What is Sonata used for?
Sonata is used to treat short-term difficulty in falling asleep.
Sonata has been shown to decrease the
time to sleep onset for up to 30 days in clinical studies.
Sonata has not been shown to increase your total sleep time
or decrease the number of times you wake up after falling asleep.
In general, medications used to bring on sleep should only be
used for 7- 10 days.
Who should not take Sonata?
Do not take Sonata if you are allergic to Sonata or any of its
ingredients. Sonata contains FD&C Yellow No. 5 dye (tartrazine)
which may cause allergic reactions in certain people such as
asthma-like symptoms and difficulty breathing. Patients who are
allergic to aspirin may be more likely to have a reaction to Sonata.
General Precautions with Sonata:
- Sonata, like all sleep medicines, may make
you drowsy during the day. The amount of drowsiness you feel
depends upon how your body reacts to Sonata and the dose of Sonata
you are taking. If you experience drowsiness during the day, talk
to your doctor.
- If your sleep problems do not get better or
you begin to have unusual thinking or behavior changes while you
take Sonata, they may be due to another medical reason. Tell your
doctor right away.
- If you abruptly stop taking Sonata you may
experience withdrawal symptoms.
- You may have more trouble falling asleep the
first few nights after you stop taking Sonata than before starting
Sonata, (rebound insomnia). This problem usually goes away on its
own after 1-2 nights.
- Withdrawal symptoms may occur when sleep
medicines are stopped suddenly after being used daily for a long
time. In some cases, withdrawal symptoms may include unpleasant
feelings. In severe cases, stomach 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 studies of Sonata so far, there
is, nevertheless, the risk of such events in association with the
use of any sleep medicines.
- There is a chance that you may experience a
certain type of memory loss (amnesia). This can usually be avoided
by taking Sonata only when you are able to get 4 or more hours of
sleep before you need to be active again. If you do have memory
problems while taking Sonata, tell your doctor.
- There is a risk of becoming dependent on
Sonata, as with any sleeping medication. However, if you have a
history of addiction to alcohol or drugs your risk of your
becoming dependent on Sonata is higher. Be sure to tell your
doctor about any previous addictions to alcohol or drugs before
you start taking Sonata.
- Until you know if Sonata causes you
drowsiness during the day, be extremely careful while doing
anything that requires your complete attention, or physical
coordination, like driving a car, or operating machinery.
- Never drink alcohol while you are taking
Sonata or any other sleep medication. Alcohol can increase the
side effects of Sonata.
What should I tell my doctor or healthcare provider?
Tell your doctor if you or your family notice any changes in your
thinking, or any new behaviors. Some people using sleep medications
have experienced:
- More outgoing or aggressive behavior than
normal
- Change in personality
- Confusion
- Strange behavior
- Agitation
- Hallucinations
- Worsening of depression
- Suicidal thoughts
Because certain other medications can interact with Sonata,
review all medications that you are taking with your doctor, or
healthcare provider, including those you take without a
prescription.
Tell your healthcare provider if you are trying to become
pregnant, are already pregnant, or are breast-feeding. Sonata is not
recommended during pregnancy or nursing.
Tell your doctor if you have or have had a history of
liver problems. Your doctor will evaluate and decide Sonata is right
for you.
What are some possible side effects of Sonata? (This is
NOT a
complete list of side effects reported with Sonata. Your healthcare
provider can discuss with you a more complete list of side effects.)
- Drowsiness
- Dizziness
- Lightheadedness
- Difficulty with coordination
For more detailed information about Sonata, ask your healthcare
provider.
Link to Sonata's Approved Labeling and Patient Information 
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Date created: January 10, 2000
Updated: August 22, 2006 |
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