DrugindexOnline^{2nd edition}

Generic Name: Quazepam (KWAY-ze-pam)
Brand Name: Doral

Doral is used for:

Treating insomnia (trouble sleeping). It may also be used for other conditions as determined by your doctor.

Doral is a benzodiazepine. It works by depressing the central nervous system (brain), causing drowsiness to aid in falling asleep.

Do NOT use Doral if:

• you are allergic to any ingredient in Doral or other benzodiazepines (eg, lorazepam)
• you are pregnant
• you have a severe mental disorder, angle-closure glaucoma, known or suspected sleep apnea (trouble breathing while asleep), or severe liver disease
• you are taking clozapine, an HIV protease inhibitor (eg, ritonavir), or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Doral :

Some medical conditions may interact with Doral . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have or have ever had alcoholism or substance abuse or dependence, or if you consume more than 3 alcohol containing drinks per day
• if you have depression, mental or mood problems, or a history of suicidal thoughts or behaviors
• if you have myasthenia gravis (a condition in which the muscles become progressively paralyzed)
• if you have liver problems, porphyria, kidney problems, or glaucoma or risk factors for glaucoma
• if you have chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, or other breathing problems

Some MEDICINES MAY INTERACT with Doral . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifampin because the effectiveness of Doral may be decreased
• Clozapine because dangerous side effects, such as confusion; sedation; excess salivation; unsteady movements; lightheadedness, especially upon standing; difficult or slow breathing; or drowsiness leading to unresponsiveness or coma may occur
• Sodium oxybate (GHB) because an increase in sleep duration and decrease in the ability to breath are likely to occur
• Anticonvulsants (eg, phenobarbital), antihistamines (eg, diphenhydramine), disulfiram, HIV protease inhibitors (eg, ritonavir), kava, nefazodone, omeprazole, valproic acid, or medicines for mental or mood problems because they may increase the actions and side effects of Doral
• Hydantoins (eg, phenytoin) because the actions and side effects may be increased by Doral ; also the effectiveness of Doral may be decreased
• Digoxin because actions and side effects may be increased by Doral
• Nondepolarizing muscle relaxants (eg, tubocurarine) because actions and side effects may be increased, decreased, or unchanged by Doral

This may not be a complete list of all interactions that may occur. Ask your health care provider if Doral may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Doral :

Use Doral as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Doral may be taken with or without food.
• Take 15 to 30 minutes before bedtime.
• If you miss a dose of Doral , take it as soon as possible. If you no longer have time for a full night's sleep or you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Doral .

Important safety information:

• Doral may cause drowsiness, dizziness, lightheadedness, or difficulty with coordination. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Doral . Using Doral alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Doral . Doral will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not drink alcohol while you are using Doral .
• Doral can cause memory loss. Take Doral only when you are able to get a full night's sleep (7 to 8 hours). Be sure to talk with your doctor if you are experiencing memory problems.
• If you notice any unusual or disturbing thoughts or behavior while taking Doral , contact your doctor at once.
• Use Doral with caution in the ELDERLY because they may be more sensitive to its effects, especially oversedation, dizziness, or confusion.
• Use Doral with extreme caution in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Doral if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. Doral is excreted in breast milk. Do not breast-feed while you are taking Doral .

When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should usually be used only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.

Sleep medicines can cause dependence, especially when used regularly, for longer than a few weeks, or at high doses. Some people develop a need to continue taking Doral . This is known as DEPENDENCE or "addiction."

WITHDRAWAL symptoms may occur when Doral is stopped suddenly after being used daily for a long time. But these symptoms can occur even if Doral has been used for only a week or two. In mild cases, WITHDRAWAL symptoms may include unpleasant feelings. Although uncommon, in more severe cases, abdominal and muscle cramps, vomiting, sweating, shakiness, and, rarely, seizures may occur. Another problem that may occur is "rebound insomnia," that is, more trouble sleeping the first few nights after the medicine is stopped than before starting the medicine. This usually goes away on its own after 1 or 2 nights. If you have been taking Doral for more than 1 or 2 weeks, do not stop taking it on your own. Your doctor may give you special directions on how to gradually decrease your dose before stopping the medicine. Always follow your doctor's directions.

Possible side effects of Doral :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; clumsiness or unsteadiness; daytime drowsiness; dizziness; fatigue; feeling of hangover; headache; lightheadedness; nausea; nervousness; sluggishness; unusual weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); depression; hallucinations; irregular heartbeat; memory loss; mental or mood changes; trouble sleeping; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include clumsiness; coma; confusion; difficult or slow breathing; dizziness; drowsiness leading to unresponsiveness or coma; lightheadedness especially upon standing; loss of consciousness.

Proper storage of Doral :

Store Doral at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Doral out of the reach of children and away from pets.

General information:

• If you have any questions about Doral , please talk with your doctor, pharmacist, or other health care provider.
• Doral is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Doral . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.