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SONATA is indicated for the short-term treatment of insomnia. SONATA has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies
Hypnotics like SONATA should generally be limited to 7 to 10 days of use, and reevaluation of the patient is recommended if they are to be taken for more than 2 to 3 weeks. Dosage and Administration of SONATA: The dose of SONATA should be individualized. The recommended dose of SONATA for most adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose of SONATA. SONATA should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep. Taking SONATA with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of SONATA on sleep latency. How to Use SONATA : 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. This medication 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 SONATA dose, take SONATA more frequently or use SONATA for a longer period of time than prescribed because this drug can be habit-forming. Also, if SONATA is used for a longer period of time, do not stop using this medication without your doctor's approval. Special Populations Elderly patients and debilitated patients appear to be more sensitive to the effects of SONATA and respond to 5 mg of SONATA. The recommended dose of SONATA for these patients is therefore 5 mg. Doses over 10 mg are not recommended. Liver impairment: Patients with mild to moderate liver impairment should be treated with SONATA 5 mg because clearance is reduced in this population. SONATA is not recommended for use in patients with severe liver impairment. Kidney impairmet: No Sonata dose adjustment is necessary in patients with mild to moderate kidney impairment. Sonata has not been adequately studied in patients with severe kidney impairment. An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because SONATA clearance is reduced in this population. Side Effects Of SONATA SONATA may cause headache, drowsiness, nausea or stomach upset may occur. If any of these effects persist or worsen, on SONATA notify your doctor promptly. Tell your doctor immediately if you have any of these serious side effects while taking SONATA : 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 while on SONATA , contact your doctor or pharmacist. SONATA Warnings: Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia with SONATA should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment with SONATA may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including Sonata. Because some of the important adverse effects of Sonata appear to be dose-related, it is important to use the lowest possible effective dose, especially in the elderly. A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics like SONATA. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes with SONATA have included bizarre behavior, agitation, hallucinations, and depersonalization. Amnesia and other neuropsychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thinking, has been reported in association with the use of sedative/hypnotics. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is SONATA induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern while taking SONATA requires careful and immediate evaluation. Following rapid dose decrease or abrupt discontinuation of the use of SONATA, there have been reports of signs and symptoms similar to those associated with withdrawal. SONATA, like other hypnotics, has CNS-depressant effects. Because of the rapid onset of action, SONATA should only be ingested immediately prior to going to bed or after the patient has gone to bed and has experienced difficulty falling asleep. Patients receiving SONATA should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination (e.g., operating machinery or driving a motor vehicle) after ingesting the drug, including potential impairment of the performance of such activities that may occur the day following ingestion of SONATA. SONATA, as well as other hypnotics, may produce additive CNS-depressant effects when co administered with other psychotropic medications, anticonvulsants, antihistamines, narcotic analgesics, anesthetics, ethanol, and other drugs that themselves produce CNS depression. SONATA should not be taken with alcohol. SONATA dosage adjustment may be necessary when SONATA is administered with other CNS-depressant agents because of the potentially additive effects. |
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