Estazolam (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.

Why this medication is prescribed
Estazolam is used on a short-term basis to help you fall asleep and stay asleep through the night.

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

How this medication should be used
Estazolam comes as a tablet to take by mouth and may be taken with or without food. It usually is taken before bedtime when needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take estazolam exactly as directed.

Estazolam can be habit-forming. 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. Do not take estazolam for more than 12 weeks or stop taking this medication without talking to your doctor. Your doctor probably will decrease your dose gradually. You may experience sleeping difficulties the first one or two nights after stopping this medication. If your sleep problems continue, talk to your doctor who will determine whether this drug is right for you.

Special precautions
Before taking estazolam:


 * tell your doctor and pharmacist if you are allergic to estazolam, alprazolam (Xanax), chlordiazepoxide (Librium, Librax), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), flurazepam (Dalmane), lorazepam (Ativan), oxazepam (Serax), prazepam (Centrax), temazepam (Restoril), triazolam (Halcion), or any other drugs.
 * tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antihistamines; cimetidine (Tagamet); digoxin (Lanoxin); disulfiram (Antabuse); medications for depression, seizures, Parkinson's disease, pain, asthma, colds, or allergies; muscle relaxants; isoniazid (INH, Laniazid, Nydrazid); oral contraceptives; probenecid (Benemid); rifampin (Rifadin); sedatives; sleeping pills; theophylline (Theo-Dur); tranquilizers; and vitamins. These medications may add to the drowsiness caused by estazolam.
 * tell your doctor if you have or have ever had glaucoma; seizures; or lung, heart, or liver disease.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking estazolam, call your doctor immediately.
 * if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking estazolam.
 * 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.
 * tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this drug.

Before taking estazolam:


 * tell your doctor and pharmacist if you are allergic to estazolam, alprazolam (Xanax), chlordiazepoxide (Librium, Librax), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), flurazepam (Dalmane), lorazepam (Ativan), oxazepam (Serax), prazepam (Centrax), temazepam (Restoril), triazolam (Halcion), or any other drugs.
 * tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antihistamines; cimetidine (Tagamet); digoxin (Lanoxin); disulfiram (Antabuse); medications for depression, seizures, Parkinson's disease, pain, asthma, colds, or allergies; muscle relaxants; isoniazid (INH, Laniazid, Nydrazid); oral contraceptives; probenecid (Benemid); rifampin (Rifadin); sedatives; sleeping pills; theophylline (Theo-Dur); tranquilizers; and vitamins. These medications may add to the drowsiness caused by estazolam.
 * tell your doctor if you have or have ever had glaucoma; seizures; or lung, heart, or liver disease.
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking estazolam, call your doctor immediately.
 * if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking estazolam.
 * 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.
 * tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this drug.

What to do if you forget a dose
If you miss a dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Minor side effects
Side effects from estazolam are common and include:


 * headache
 * heartburn
 * diarrhea
 * hangover effect (grogginess)
 * drowsiness
 * dizziness or lightheadedness
 * weakness
 * dry mouth

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


 * constipation
 * difficulty urinating
 * frequent urination
 * blurred vision

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


 * jaw, neck, and back muscle spasms
 * slow or difficult speech
 * persistent, fine tremor or inability to sit still
 * fever
 * difficulty breathing or swallowing
 * severe skin rash
 * yellowing of the skin or eyes
 * irregular heartbeat

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].

Storage conditions needed for 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). 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.

Other information
Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication.