Butabarbital

secbutobarabitone sodium

WHY is this medicine prescribed?

Butabarbital is used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep). It is also used to relieve anxiety, including anxiety before surgery. Butabarbital is in a class of medications called barbiturates. It works by slowing activity in the brain.

HOW should this medicine be used?

Butabarbital comes as a tablet and a solution (liquid) to take by mouth. When butabarbital is used to treat insomnia, it is usually taken at bedtime as needed for sleep. When butabarbital is used to relieve anxiety before surgery, it is usually taken 60 to 90 minutes before surgery. When butabarbital is used to relieve anxiety, it is usually taken three to four times a day. If you are taking butabarbital on a regular schedule, take it at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take butabarbital exactly as directed.

Your sleep problems should improve within 7 to 10 days after you start taking butabarbital. Call your doctor if your sleep problems do not improve during this time, if they get worse at any time during your treatment, or if you notice any changes in your thoughts or behavior.

Butabarbital should normally be taken for short periods of time. If you take butabarbital for 2 weeks or longer, butabarbital may not help you sleep as well or control your anxiety as it did when you first began to take the medication. If you take butabarbital for a long time, you also may develop dependence ('addiction,' a need to continue taking the medication) on butabarbital. Talk to your doctor about the risks of taking butabarbital for 2 weeks or longer. Do not take a larger dose of butabarbital, take it more often, or take it for a longer time than prescribed by your doctor.

Do not stop taking butabarbital without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking butabarbital, you may develop anxiety, muscle twitching, uncontrollable shaking of your hands or fingers, weakness, dizziness, changes in vision, nausea, vomiting, or difficulty falling asleep or staying asleep, or you may experience more severe withdrawal symptoms such as seizures or extreme confusion.

Are there OTHER USES for this medicine?

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking butabarbital,

• tell your doctor and pharmacist if you are allergic to butabarbital; other barbiturates such as amobarbital (Amytal, in Tuinal), pentobarbital, phenobarbital, or secobarbital (Seconal); tartrazine (a yellow dye found in some foods and medications); aspirin; or any other medications. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking butabarbital. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had porphyria (condition in which certain natural substances build up in the body and may cause stomach pain, changes in thinking and behavior, and other symptoms). Your doctor will probably tell you not to take butabarbital.
• tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have ever thought about killing yourself or tried to do so and if you have or have ever had asthma or any condition that causes shortness of breath or difficulty breathing; depression; seizures; or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking butabarbital, call your doctor immediately. Butabarbital may harm the fetus.
• you should know that butabarbital may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, injections, implants, or intrauterine devices). Talk to your doctor about methods of birth control that will work for you during your treatment with butabarbital. Tell your doctor if you have a missed period or think you may be pregnant while you are taking butabarbital.
• talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should not usually take butabarbital because it is not as safe or effective as other medication(s) that can be used to treat the same condition.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking butabarbital.
• you should know that this medication may make you drowsy during the daytime, may decrease your mental alertness, and may increase the risk that you could fall. Take extra care to be sure you do not fall, especially if you get out of bed in the middle of the night. Do not drive a car or operate machinery until you know how this medication affects you.
• do not drink alcohol during your treatment with butabarbital. Alcohol can make the side effects of butabarbital worse.
• you should know that some people who took medications for sleep got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, or were involved in other activities while partially asleep. After they woke up, these people were usually unable to remember what they had done. Call your doctor right away if you find out that you have been driving or doing anything else while you were sleeping.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you are taking butabarbital on a regular basis, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Butabarbital may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• difficulty falling asleep or staying asleep
• nightmares
• headache
• dizziness
• depression
• nervousness
• agitation
• excitement
• confusion
• restlessness
• nausea
• vomiting
• constipation

Some side effects can be serious. If you experience any of the following symptoms, or those listed in the SPECIAL PRECAUTIONS sections, call your doctor immediately:

• hallucinating (seeing things or hearing voices that do not exist)
• slow, shallow breathing
• slow heartbeat
• fainting
• hives
• rash
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• hoarseness

Butabarbital may cause other side effects. Tell your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• unsteadiness
• slurred speech
• uncontrollable eye movements
• confusion
• poor judgment
• irritability
• difficulty falling asleep or staying asleep
• fast, slowed or shallow breathing
• narrowed pupils (black circles in the middle of the eye)
• decreased urination
• fast heartbeat
• low body temperature
• coma (loss of consciousness for a periol of time)

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to butabarbital.

Do not let anyone else take your medication. Butabarbital is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2019.