Secobarbital (patient information)

IMPORTANT WARNING:
[Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Sedative and http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html.

Why is this medication prescribed
See the MedWatch notification at the beginning of the monograph.

Secobarbital, a barbiturate, is used in the short-term treatment of insomnia to help you fall asleep and stay asleep through the night. It is also used as a sedative to relieve anxiety before surgery.

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

How should this medicine be used
See the MedWatch notification at the beginning of the monograph.

Secobarbital comes as a capsule to take by mouth. It usually is taken at bedtime as needed for sleep. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Your prescription is not refillable. Take secobarbital exactly as directed.

Secobarbital can be habit-forming. Do not use secobarbital for more than 2 weeks. Do not take a larger dose, take it more often, or for a longer time than your doctor tells you to. Tolerance may develop with long-term or excessive use, making the drug less effective. If your sleep problems continue, talk to your doctor, who will determine whether this drug is right for you.

What special precautions should I follow
See the MedWatch notification at the beginning of the monograph.

Before taking secobarbital:
 * tell your doctor and pharmacist if you are allergic to secobarbital or any other drugs.
 * tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially acetaminophen (Tylenol); anticoagulants ('blood thinners') such as warfarin (Coumadin); antihistamines; carbamazepine (Tegretol); clonazepam (Klonopin); disulfiram (Antabuse); felodipine (Plendil); fenoprofen (Nalfon); MAO inhibitors [phenelzine (Nardil) or tranylcypromine (Parnate)]; medications for depression, seizures, pain, asthma, colds, or allergies; metoprolol (Lopressor); metronidazole (Flagyl); muscle relaxants; phenylbutazone (Azolid, Butazolidin); propranolol (Inderal); rifampin (Rifadin); sedatives; sleeping pills; steroids; theophylline (Theo-Dur); tranquilizers; valproic acid (Depakene); verapamil (Calan); and vitamins. These medications may add to the drowsiness caused by secobarbital.
 * tell your doctor if you have or have ever had anemia; asthma; seizures; or lung, heart, or liver disease.
 * use a method of birth control other than oral contraceptives while taking this medication. Secobarbital can decrease the effectiveness of oral contraceptives.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking secobarbital, call your doctor immediately.
 * if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking secobarbital.
 * you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
 * remember that alcohol can add to the drowsiness caused by this drug.

What should I do if I forget a dose
Do not take the missed dose when you remember it. Skip it completely; then take the next dose at the regularly scheduled time. Do not take a double dose to make up for a missed one.

Side effects
See the MedWatch notification at the beginning of the monograph.

Mild side effects
Side effects from secobarbital are common and include:


 * drowsiness
 * headache
 * dizziness
 * depression
 * excitement (especially in children)
 * upset stomach

Tell your doctor if any of these symptoms are severe or do not go away:


 * vomiting
 * nightmares
 * increased dreaming
 * constipation
 * joint or muscle pain

Severe side effects
If you experience any of the following symptoms, call your doctor immediately:


 * mouth sores
 * sore throat
 * easy bruising
 * bloody nose
 * unusual bleeding
 * fever
 * difficulty breathing or swallowing
 * severe skin rash

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 [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine
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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know
See the MedWatch notification at the beginning of the monograph.

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

Do not let anyone else take your medication.

Brand names

 * Seconal® Sodium Pulvules®

Brand names of combination products

 * Tuinal® 100 mg Pulvules® containing Secobarbital Sodium and Amobarbital Sodium