When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to secobarbital or other barbiturates (such as phenobarbital). You should not use this medicine if you are pregnant, or if you have porphyria, liver disease, or lung disease.

How to Use This Medicine:
Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

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

• There are many other drugs that interact with this medicine. Make sure your doctor knows all other medicines you are using.
• Make sure your doctor knows if you are using a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), an antifungal medicine (such as griseofulvin, or Grifulvin V®), an antibiotic medicine (such as doxycycline, or Vibramycin®), a medicine for seizures (such as phenytoin, sodium valproate, valproic acid, Depacon®, Depakene®, or Dilantin®), or blood thinners (such as warfarin or Coumadin®).
• Make sure your doctor knows if you are using an MAO inhibitor (such as Eldepryl®, Marplan®, Nardil®, or Parnate®), or a hormone medicine (such as estradiol, estrone, progesterone, Estrace®, or Prometrium®).
• 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.
• Make sure your doctor knows if you are breastfeeding, or if you have liver disease, severe pain in any part of your body, severe depression, or a history of drug addiction.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, trouble breathing, or any swelling of your hands, face, or mouth when you take this medicine.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. This medicine may also cause sleep-related behaviors such as sleep-driving, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• 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.

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
• Abnormal behavior or problems with speech.
• Anxiety or agitation.
• Dark-colored urine or pale stools.
• Lightheadedness or fainting.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Pale skin or pale lip color.
• Slow heartbeat.
• Yellowing of your skin or the whites of your eyes.

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

• Confusion or trouble sleeping.
• Fever or headache.
• Mild nausea or constipation.

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