Sonata

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Sonata Information

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. It has not been shown to increase total sleep time or decrease the number of awakenings.

Hypnotics 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. Sonata should not be prescribed in quantities exceeding a 1-month supply.

Sonata Ingredients and Composition

How Does Sonata Work?

Pharmacodynamics and Mechanism of Action

While Sonata (zaleplon) is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties, it interacts with the gamma-aminobutyric acid-benzodiazepine (GABA-BZ) receptor complex. Subunit modulation of the GABA-BZ receptor chloride channel macromolecular complex is hypothesized to be responsible for some of the pharmacological properties of benzodiazepines, which include sedative, anxiolytic, muscle relaxant, and anticonvulsive effects in animal models.

Other nonclinical studies have also shown that zaleplon, the active ingredient in Sonata, binds selectively to the brain omega-1 receptor situated on the alpha subunit of the GABAA/chloride ion channel receptor complex and potentiates t-butyl-bicyclophosphorothionate (TBPS) binding. Studies of binding of zaleplon to recombinant GABAA receptors (a1b1g2 [omega-1] and a2b1g2 [omega-2]) have shown that zaleplon has a low affinity for these receptors, with preferential binding to the omega-1 receptor.

How To Take Sonata and Sonata Dosage and Administration

The dose of Sonata should be individualized. The recommended SOnate dose for most nonelderly adults is 10 mg. For certain low weight individuals, 5 mg may be a sufficient dose. Although the risk of certain adverse events associated with the use of Sonata appears to be dose dependent, the 20 mg dose has been shown to be adequately tolerated and may be considered for the occasional patient who does not benefit from a trial of a lower dose. Doses above 20 mg have not been adequately evaluated and are not recommended.

Sonata should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep. Taking it 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.

Special Populations

Elderly patients and debilitated patients appear to be more sensitive to the effects of hypnotics, and respond to 5 mg of Sonata. The recommended Sotana dose for these patients is therefore 5 mg. Doses over 10 mg are not recommended.

Hepatic insufficiency
Patients with mild to moderate hepatic 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 hepatic impairment.

Renal insufficiency No dose adjustment is necessary in patients with mild to moderate renal impairment. Sonata has not been adequately studied in patients with severe renal impairment.

An initial dose of 5 mg should be given to patients concomitantly taking cimetidine because zaleplon clearance is reduced in this population.

If you suspect a Sonata Overdose

There is limited pre-marketing clinical experience with the effects of an overdosage of Sonata. Two cases of Sonata overdose were reported. One was the accidental ingestion by a 2½ year old boy of 20 mg to 40 mg of zaleplon. The second was a 20 year old man who took 100 mg zaleplon plus 2.25 mg of triazolam. Both were treated and recovered uneventfully.

Signs and Symptoms

Signs and symptoms of overdose effects of CNS depressants can be expected to present as exaggerations of the pharmacological effects noted in preclinical testing. Overdose is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy; in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma, and very rarely death.

Recommended Treatment

General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Animal studies suggest that flumazenil is an antagonist to zaleplon. However, there is no pre-marketing clinical experience with the use of flumazenil as an antidote to a Sonata overdose. As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention.

Poison Control Center

As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.

Sonata Side Effects

Sonata Warnings

Sonata Precautions and Contraindications

Timing of Drug Administration

Sonata should be taken immediately before bedtime or after the patient has gone to bed and has experienced difficulty falling asleep. As with all sedative/hypnotics, taking Sonata while still up and about may result in short-term memory impairment, hallucinations, impaired coordination, dizziness, and lightheadedness.

Use in the elderly and/or debilitated patients

Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. A dose of 5 mg is recommended for elderly patients to decrease the possibility of side effects. Elderly and/or debilitated patients should be monitored closely.

Use in patients with concomitant illness

Clinical experience with Sonata in patients with concomitant systemic illness is limited. Sonata should be used with caution in patients with diseases or conditions that could affect metabolism or hemodynamic responses.

Although preliminary studies did not reveal respiratory depressant effects at hypnotic doses of Sonata in normal subjects, caution should be observed if Sonata (zaleplon) is prescribed to patients with compromised respiratory function, because sedative/hypnotics have the capacity to depress respiratory drive. Controlled trials of acute administration of Sonata 10 mg in patients with mild to moderate chronic obstructive pulmonary disease or moderate obstructive sleep apnea showed no evidence of alterations in blood gases or apnea/hypopnea index, respectively. However, patients with compromised respiration due to preexisting illness should be monitored carefully.

The dose of Sonata should be reduced to 5 mg in patients with mild to moderate hepatic impairment. It is not recommended for use in patients with severe hepatic impairment.

No dose adjustment is necessary in patients with mild to moderate renal impairment. Sonata has not been adequately studied in patients with severe renal impairment.

Use in patients with depression

As with other sedative/hypnotic drugs, Sonata should be administered with caution to patients exhibiting signs or symptoms of depression. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional Sonata overdosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.

Sonata contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Contraindications to Sonata

Hypersensitivity to zaleplon or any excipients in the formulation

Sonata Drug Interactions

Because the active ingredient of Sonata, zaleplon is primarily metabolized by aldehyde oxidase, and to a lesser extent by CYP3A4, inhibitors of these enzymes might be expected to decrease zaleplon's clearance and inducers of these enzymes might be expected to increase its clearance. Zaleplon has been shown to have minimal effects on the kinetics of warfarin (both R- and S-forms), imipramine, ethanol, ibuprofen, diphenhydramine, thioridazine, and digoxin. However, the effects of zaleplon on inhibition of enzymes involved in the metabolism of other drugs have not been studied.

Sonata Clinical Trials and Studies

Sonata Pill Identification / ID and Appearance

Sonata (zaleplon) capsules are available in bottles of 100 capsules in the following dosage strengths:

The appearance of these capsules is a trademark of Wyeth Pharmaceuticals.

Storing Sonata

Store SOnata at controlled room temperature, 20°C to 25°C (68°F to 77°F).

Additional Patient Information for Sonata

Special Concerns

There are some special problems that may occur while taking sleep medicines.

Memory Problems

Sleep medicines, such as Sonata, may cause a special type of memory loss or "amnesia." When this occurs, a person may not remember what has happened for several hours after taking the medicine. This is usually not a problem since most people fall asleep after taking the medicine. Memory loss can be a problem, however, when sleep medicines are taken while traveling, such as during an airplane flight and the person wakes up before the effect of the medicine is gone. This has been called "traveler's amnesia." Memory problems are not common while taking Sonata. In most instances memory problems can be avoided if you take Sonata only when you are able to get 4 or more hours of sleep before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.

Tolerance

When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as "tolerance." Development of tolerance to Sonata has not been observed in outpatient clinical studies of up to 4 weeks in duration; however, it is unknown if the benefits of Sonata in falling asleep more quickly persist beyond 4 weeks. Sleep medicines should, in most cases, be used only for short periods of time, such as 1 or 2 days and generally no longer than 1 or 2 weeks. If your sleep problems continue, consult your doctor, who will determine whether other measures are needed to overcome your sleep problems.

Sonata Addiction and Dependency

Sonata Withdrawal Symptoms

Withdrawal symptoms may occur when sleep medicines such as Sonata are stopped suddenly after being used daily for a long time. In some cases, these symptoms can occur even if the medicine has been used for only a week or two. In mild cases, withdrawal symptoms may include unpleasant feelings. In more severe cases, abdominal 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 the relatively limited controlled trials experience with Sonata, there is, nevertheless, the risk of such events in association with the use of any sleep medicines.

Another problem that may occur when sleep medicines are stopped is known as "rebound insomnia". This means that a person may have more trouble sleeping the first few nights after the medicine is stopped than before starting the medicine. If you should experience rebound insomnia, do not get discouraged. This problem usually goes away on its own after 1 or 2 nights.

If you have been taking Sonata or any other sleep medicine for more than 1 or 2 weeks, do not stop taking it on your own. Always follow your doctor's directions.

Changes In Behavior and Thinking

Some people using sleep medicines such as Sonata have experienced unusual changes in their thinking and/or behavior. These effects are not common. However, they have included:

How often these effects occur depends on several factors, such as a person's general health, the use of other medicines, and which sleep medicine is being used. Clinical experience with Sonata (zaleplon) suggests that it is uncommonly associated with these behavior changes.

It is also important to realize that it is rarely clear whether these behavior changes are caused by the medicine, an illness, or occur on their own. In fact, sleep problems that do not improve may be due to illnesses that were present before the medicine was used. If you or your family notice any changes in your behavior, or if you have any unusual or disturbing thoughts, call your doctor immediately.

Taking Sonata during Pregnancy or Breast-feeding

Sleep medicines may cause sedation or other potential effects in the unborn baby when used during the last weeks of pregnancy. Therefore, Sonata is not recommended for use during pregnancy. Be sure to tell your doctor if you are pregnant, if you are planning to become pregnant, or if you become pregnant while taking Sonata.

In addition, a very small amount of Sonata may be present in breast milk after use of the medication. The effects of very small amounts of Sonata on an infant are not known; therefore, as with all other hypnotics, it is recommended that you not take Sonata if you are breastfeeding a baby.

Safe Use of Sleeping Medicines

To ensure the safe and effective use of Sonata or any other sleep medicine, you should observe the following cautions:

  1. Sonata is a prescription medicine and should be used ONLY as directed by your doctor. Follow your doctor's instructions about how to take, when to take, and how long to take Sonata.

  2. Never use Sonata or any other sleep medicine for longer than directed by your doctor.
  3. If you notice any unusual and/or disturbing thoughts or behavior during treatment with Sonata or any other sleep medicine, contact your doctor.
  4. Tell your doctor about any medicines you may be taking, including medicines you may buy without a prescription. You should also tell your doctor if you drink alcohol. DO NOT use alcohol while taking Sonata or any other sleep medicine.
  5. Do not take Sonata unless you are able to get 4 or more hours of sleep before you must be active again.
  6. Do not increase the prescribed dose of Sonata or any other sleep medicine unless instructed by your doctor.
  7. When you first start taking Sonata or any other sleep medicine, until you know whether the medicine will still have some carryover effect in you the next day, use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft.
  8. Be aware that you may have more sleeping problems the first night or two after stopping any sleep medicine.
  9. Be sure to tell your doctor if you are pregnant, if you are planning to become pregnant, if you become pregnant, or are breastfeeding a baby while taking Sonata.
  10. 0. As with all prescription medicines, never share Sonata or any other sleep medicine with anyone else. Always store Sonata or any other sleep medicine in the original container and out of reach of children.
  11. 1. Be sure to tell your physician if you suffer from depression.
  12. 2. Sonata works very quickly. You should only take Sonata immediately before going to bed or after you have gone to bed and are having difficulty falling asleep.
  13. 3. For Sonata to work best, you should not take Sonata with or immediately after a high-fat/heavy meal.
  14. 4. Some people should start with the lowest dose (5 mg) of Sonata; these include the elderly (ie, ages 65 and over) and people with liver disease.

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