Butabarbital (bue-ta-BAR-bi-tal)

Treats insomnia. Also used to make you feel sleepy before surgery or a procedure. This medicine is a barbiturate.

Brand Name(s):

Butisol Sodium

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Oral liquid: Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• This medicine is not for long-term use.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• If you are using this medicine for insomnia, it is best to take it just before bedtime or when you are having trouble falling asleep. Use this medicine only when you cannot sleep. You do not need to take it on a schedule.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how butabarbital works. Tell your doctor if you are taking any of the following:
  • Doxycycline, griseofulvin
  • Birth control pills containing estradiol, estrone, or progesterone
  • Blood thinner (including acenocoumarol, dicumarol, phenprocoumon, warfarin)
  • Medicine to treat depression (including MAO inhibitor)
  • Seizure medicine (including phenytoin, sodium valproate, valproic acid)
  • Steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (including condoms or spermicide) along with your pills.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, breathing problems (including asthma), or severe pain in any part of your body. Also tell your doctor if you have depression, or a history of alcohol or drug addiction, or thoughts of suicide.
• Some brands of butabarbital contain a yellow dye called tartrazine, which may cause severe allergic reactions. Tell your doctor if you have any allergies.
• This medicine may make you dizzy or drowsy. It may also cause decreased alertness or trouble with thinking or trouble with controlling body movements, which may lead to falls. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine may cause unusual moods and behaviors. You may also do things while you are still asleep that you may not remember the next morning, including driving, eating, having sex, sleepwalking, or making phone calls. Tell your doctor right away if you have learned that this has happened.
• Do not use this medicine to treat insomnia or other sleeping problems without checking first with your doctor. If you still have trouble sleeping after 7 to 10 days of using this medicine, check with your doctor right away.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, agitation, depression, nervousness, unusual moods or behavior, thoughts of hurting yourself
• Seeing, hearing, or feeling things that are not there
• Severe confusion, drowsiness, or muscle weakness
• Trouble breathing, blue lips, fingernails, or skin, slow heartbeat

If you notice these less serious side effects, talk with your doctor:

• Daytime drowsiness, headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

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