Butisol Sodium

What is Butisol Sodium used for?

• Butisol Sodium is used to treat sleep problems.
• Butisol Sodium may be given to you for other reasons. Talk to your doctor.

Before taking Butisol Sodium, tell your doctor:

• If you are allergic to Butisol Sodium; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have or have ever had low mood (depression) or thoughts of killing yourself.
• If you have ever abused drugs.
• If you have ever had porphyria.
• If you have liver disease.
• If you are taking any other drugs that can make you sleepy. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Butisol Sodium with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Butisol Sodium?

• Tell all of your health care providers that you take Butisol Sodium. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert after you take Butisol Sodium. You may still feel sleepy the day after you take Butisol Sodium. Avoid these tasks or actions until you feel fully awake.
• Have your blood work checked if you are on Butisol Sodium for a long time. Talk with your doctor.
• This medicine may be habit-forming with long-term use.
• When sleep drugs are used nightly for more than a few weeks, they may not work as well to help sleep problems. This is known as tolerance. Only use sleep drugs for a short time. If sleep problems last, call the doctor.
• Do not take Butisol Sodium for longer than you were told by your doctor.
• If you have been taking Butisol Sodium for many weeks, talk with your doctor before stopping. You may want to slowly stop Butisol Sodium.
• Avoid alcohol while taking Butisol Sodium. Do not take Butisol Sodium if you drank alcohol that evening or before bed.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Some people have done certain tasks or actions while they were not fully awake like driving, making and eating food, and having sex. Most of the time, people do not remember doing these things. Tell your doctor if this happens to you.
• If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
• This medicine may make you feel sleepy and less alert. This may lead to falling. The chance of falling is higher in older people. If you have questions, talk with the doctor.
• If you are 65 or older, use Butisol Sodium with care. You could have more side effects.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Butisol Sodium.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Butisol Sodium, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Butisol Sodium best taken?

Use Butisol Sodium as ordered by your doctor. Read all information given to you. Follow all instructions closely.

For sleep:

• Take Butisol Sodium at bedtime.
• Take Butisol Sodium right before you get into bed.
• Do not take Butisol Sodium unless you can get a full night's sleep (at least 7 to 8 hours) before you need to be active again.
• If you still have trouble sleeping after 7 to 10 days, call your doctor.

What do I do if I miss a dose?

For sleep:

• If you take Butisol Sodium on a regular basis, take a missed dose as soon as you think about it.
• If you will not be able to get a full night's sleep (at least 7 hours) after taking the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Butisol Sodium is taken on an as needed basis. Do not take more often than told by the doctor.

Before surgery:

• Call your doctor to find out what to do.

For other reasons:

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Butisol Sodium that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Mental, mood, or behavior changes that are new or worse.
• Shortness of breath.
• Very upset stomach or throwing up.
• Worse trouble sleeping.
• Feeling nervous and excitable.
• Hallucinations (seeing or hearing things that are not there).
• Not thinking clearly.

What are some other side effects of Butisol Sodium?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Butisol Sodium?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Butisol Sodium, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Butisol Sodium or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Butisol Sodium. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.