Sonata Sleep Medication

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SONATA is indicated for the short-term treatment of insomnia. SONATA is not indicated for use in pediatric patients. Although SONATA improved sleep time from baseline in clinical trials, it has not been shown to increase total time slep or decrease awakenings vs. placebo.

Hypnotics should generally be limited to 7 to 10 days of use, and reevaluation of the patient is recommended if hypnotics are taken for more than 2 to 3 weeks.

IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ZALEPLON - ORAL (ZALL-eh-plon)

COMMON BRAND NAME(S): Sonata

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.