Sonata belongs to the class of drugs called hypnotics, and is used for the short term treatment of sleep problems (insomnia). Hypnotics should generally be limited to 7 to 10 days of use. Reevaluation is recommended if hypnotics are taken for more than 2 to 3 weeks.

Sonata

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.

Uses
Sonata is used for the short-term treatment of sleep problems (insomnia).

How to Use
Take Sonata by mouth, immediately before bedtime or after you have gone to bed and have difficulty sleeping, as directed by your doctor. Do not take Sonata with, or immediately after, a high-fat or heavy meal. Sonata helps you fall asleep. To minimize side effects while you are awake (e.g., dizziness or memory trouble), take Sonata 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 Sonata for longer than ten days without your doctor's approval. If your sleep problems continue, consult with your doctor. Use Sonata 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 Sonata 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 Sonata. 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 Sonata. Sonata should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Sonata passes into breast milk. Because of the potential risk to the infant, breast-feeding while using Sonata 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 Sonata 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.

Do not take SONATA unless you are able to get 4 or more hours of sleep before you must be active again.

SONATA is indicated for the short-term treatment of insomnia. Although SONATA?improved sleep time from baseline in clinical trials, it has not been shown to increase total time slept or decrease awakenings vs. placebo. Hypnotics should generally be limited to 7 to 10 days of use, and reevaluation of patients is recommended if hypnotics are taken for more than 2 to 3 weeks. SONATA?prescriptions should not exceed a 1-month supply. Until patients know how they will react to sleep agents, they should not engage in activities requiring mental alertness or motor coordination (eg, driving or operating machinery) after taking SONATA?or any sleep agent. In clinical trials, the most common side effects were headache, dizziness, and somnolence. As with any sedative/hypnotic, abrupt treatment discontinuation can produce signs and symptoms of withdrawal and rebound insomnia.

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