Doral

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Quazepam has a risk for abuse and addiction, which can lead to overdose and death. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems (especially opioid medications such as codeine, hydrocodone) may cause very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of quazepam that works, and take it for the shortest possible time. Be sure you know how to take quazepam and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Suddenly stopping this medication may cause serious (possibly fatal) withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as headaches, restlessness, hallucinations/confusion, depression, nausea, or seizures. Withdrawal symptoms may sometimes last weeks to months.

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start using quazepam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once nightly, 30 minutes before bedtime. The dosage is based on your medical condition, age, and response to therapy.

Although unlikely, this drug can rarely cause temporary memory loss. To avoid this effect, do not take a dose of this drug unless you have time for a full night's sleep that lasts at least 7-8 hours. For example, do not take this drug during an overnight plane flight of less than 8 hours.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

You may experience trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and it is normal. It will usually go away after 1-2 nights. If this effect continues, contact your doctor.

Inform your doctor if your condition lasts or gets worse after 7-10 days.

See also Warning section.

Dizziness, loss of coordination, or blurred vision may occur. To minimize falls, remember to get up slowly when rising from a seated or lying position. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: uncontrolled movements (tremor), sweating, unusual feelings of well-being (euphoria), memory loss, mental/mood changes (such as hallucinations, agitation, restlessness, confusion, depression, rare thoughts of suicide), increased or vivid dreams, vision changes, fainting, signs of infection (such as sore throat that doesn't go away, fever), unusual paleness, unusual tiredness, fast/pounding/irregular heartbeat, yellowing of the eyes/skin, dark urine.

Some people who take sleep medications have reported getting out of bed and sleepwalking, driving, eating, talking on the phone, or having sex while not fully awake. Often they do not remember these activities. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking quazepam.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking quazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as lorazepam, diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, mental/mood problems (such as depression, panic disorder), lung problems (such as pulmonary insufficiency, sleep apnea), seizures, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol).

This drug may make you dizzy or drowsy or temporarily blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, loss of coordination, and confusion. These side effects can increase the risk of falling.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using quazepam. Quazepam may harm an unborn baby. Newborn babies of mothers who use this medication late in pregnancy may have symptoms such as slow/shallow breathing, nonstop crying, shaking, or trouble feeding. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are: cimetidine, clozapine, disulfiram, certain SSRI antidepressants (fluoxetine, fluvoxamine), kava, nefazodone, sodium oxybate.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Do not share this medication with others. Sharing it is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases.

If you are using this drug for a long time, lab and/or medical tests (such as liver/kidney function, blood count) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you require treatment for more than 7-10 days, lab and/or medical tests should be done to find the cause of your sleep problem. Consult with your doctor for more details.

As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Consult your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and avoiding going to bed too early each night.

If you miss a dose, take it as soon as you remember if it is still near bedtime. If it is already the next day, take your next dose that night at bedtime. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.