Sonata

DRUG DESCRIPTION

Zaleplon is a nonbenzodiazepine hypnotic from the pyrazolopyrimidine class.
The chemical name of zaleplon is N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide.
Its empirical formula is C₁₇H₁₅N₅O, and its
molecular weight is 305.34. The structural formula is shown below.

Zaleplon is a white to off-white powder that is practically insoluble in water and sparingly soluble in alcohol or propylene glycol. Its partition coefficient in octanol/water is constant (log PC = 1.23) over the pH range of 1 to 7.

Sonata® capsules contain zaleplon as the active ingredient. Inactive ingredients consist of microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1, FD&C green #3, and FD&C yellow #5.

What are the possible side effects of zaleplon (Sonata)?

Zaleplon may cause a severe allergic reaction. Stop taking zaleplon and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using zaleplon and call your doctor at once if you have any of these serious side effects:

• aggression, agitation, changes in behavior;


• thoughts of hurting yourself; or


• hallucinations (hearing or seeing things).

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Sonata »

What are the precautions when taking zaleplon (Sonata)?

Before taking zaleplon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, very high/low blood pressure, breathing problems (e.g., asthma), depression, history of drug/alcohol abuse.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting...

Read All Potential Precautions of Sonata »

Sonata Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, short-term memory loss, or lack of coordination may occur, especially during the first 2 hours after you take the medication. Taking the medication properly just before falling asleep will reduce your risk of these effects. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., agitation, seeing/hearing things that are not there, rare thoughts of suicide), unusual behavior.

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor immediately. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zaleplon.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking zaleplon, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, very high/low blood pressure, breathing problems (e.g., asthma), depression, history of drug/alcohol abuse.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist that you are using this medication.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of this drug, especially memory problems.

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 and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Sonata Patient Information Including Side Effects

Brand Names: Sonata

Generic Name: zaleplon (Pronunciation: ZAH le plon)

• What is zaleplon (Sonata)?


• What are the possible side effects of zaleplon (Sonata)?


• What is the most important information I should know about zaleplon (Sonata)?


• What should I discuss with my healthcare provider before taking zaleplon (Sonata)?


• How should I take zaleplon (Sonata)?


• What happens if I miss a dose (Sonata)?


• What happens if I overdose (Sonata)?


• What should I avoid while taking zaleplon (Sonata)?


• What other drugs will affect zaleplon (Sonata)?


• Where can I get more information?

What is zaleplon (Sonata)?

Zaleplon is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Zaleplon is used to treat insomnia. This medication causes relaxation to help you fall asleep and stay asleep.

Zaleplon may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of zaleplon (Sonata)?

Zaleplon may cause a severe allergic reaction. Stop taking zaleplon and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using zaleplon and call your doctor at once if you have any of these serious side effects:

• aggression, agitation, changes in behavior;


• thoughts of hurting yourself; or


• hallucinations (hearing or seeing things).

Less serious side effects may include:

• day-time drowsiness, dizziness, "hangover" feeling;


• problems with memory or concentration;


• numbness or tingling;


• anxiety, depression, nervous feeling;


• problems with vision;


• headache;


• nausea, stomach pain, loss of appetite, constipation;


• dry mouth;


• increased menstrual pain (cramps);


• back pain, joint or muscle pain; or


• mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about zaleplon (Sonata)?

Zaleplon may cause a severe allergic reaction. Stop taking zaleplon and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Zaleplon will make you fall asleep. Never take this medication during your normal waking hours, unless you have at least 4 hours to dedicate to sleeping.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zaleplon and talk with your doctor about another treatment for your sleep disorder.

Zaleplon can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not drink alcohol while you are taking zaleplon. It can increase some of the side effects of zaleplon, including drowsiness.

Zaleplon may be habit-forming and should be used only by the person it was prescribed for. Zaleplon should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

You may have withdrawal symptoms if you stop taking zaleplon after taking it over several days in a row. Do not stop taking zaleplon suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

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