USES: This medication is used for the short-term
treatment of sleep problems (insomnia).
HOW TO USE: Take this product by mouth, immediately before bedtime or after
you have gone to bed and have difficulty sleeping, as directed by your doctor.
Do not take this medication with, or immediately after, a high-fat or heavy
meal. This medication helps you fall asleep. To minimize side effects while
you are awake (e.g., dizziness or memory trouble), take this medication when
you are in bed and are able to get at least four hours of sleep before you
need to be active again. Do not use this medication for longer than ten days
without your doctor's approval. If your sleep problems continue, consult
with your doctor. Use this medication exactly as prescribed. Do not increase
your dose, take it more frequently or use it for a longer period of time
than prescribed because this drug can be habit-forming. Also, if used for
a longer period of time, do not stop using this medication without your doctor's
approval.
SIDE EFFECTS: Headache, drowsiness, nausea or stomach upset may occur. If
any of these effects persist or worsen, notify your doctor promptly. Tell
your doctor immediately if you have any of these serious side effects: dizziness,
weakness, loss of coordination, muscle joint pain. Tell your doctor immediately
if you have any of these unlikely but serious side effects: mental/mood changes,
persistent trouble sleeping, memory problems, loss of appetite, tingling
of the hands or feet, rash, itching, tremors, eye/ear problems. Tell your
doctor immediately if you have any of these very unlikely but serious side
effects: fast/slow/irregular pulse, chest pain, trouble breathing, blood
in the stool, unusual thirst, change in amount of urine. If you notice other
effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, including: allergies,
liver disease, lung/breathing problems, mental/mood problems (e.g., depression),
alcohol use or drug dependence. Avoid alcohol, as it may aggravate certain
side effects of this drug (e.g., dizziness, drowsiness). Use caution when
performing tasks requiring alertness (e.g., driving). You may have trouble
sleeping the first few nights after you stop using this medication. This
problem usually goes away after one or two nights. If sleep problems persist,
consult with your doctor. Use with caution in the elderly, as they may be
more sensitive to the effects of this medication. This medication should
be used only when clearly needed during pregnancy. Discuss the risks and
benefits with your doctor. This medication passes into breast milk. Because
of the potential risk to the infant, breast-feeding while using this medication
is not recommended. Consult your doctor before breast- feeding.
DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription
medication you may use, especially of: rifamycin antibiotics (e.g., rifampin,
rifabutin), antidepressants (e.g., imipramine, amitriptyline), ulcer medication
(e.g., cimetidine). Also report any drugs causing drowsiness such as: other
medicines for sleep, sedatives, tranquilizers, anti-anxiety drugs, narcotic
pain relievers (e.g., codeine), psychiatric medications (e.g., thioridazine),
anti-seizure medications (e.g., phenytoin, phenobarbital, carbamazepine),
muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine).
Check all medicine labels carefully, especially cough-and-cold preparations,
since many contain antihistamines (e.g., diphenhydramine). Consult your pharmacist
regarding safe use of these products. Do not start or stop any medicine without
doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison control center
or emergency room immediately. Symptoms of overdose may include drowsiness;
confusion; sluggishness; loss of coordination; slow, shallow breathing; and
loss of consciousness.
NOTES: Do not share this medication with others.
MISSED DOSE: Not applicable.
STORAGE: Store at room temperature between 68 and 77 degrees F (20 to 25
degrees C) away from light and moisture.
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