Doral

Doral

quazepam

This medication is used for the short-term treatment of patients with trouble sleeping (insomnia). It is generally used for 7-10 days. It may help you fall asleep faster and decrease the number of times you awaken during the night. It may also help you sleep for a longer period of time. Quazepam belongs to a class of medications called benzodiazepines. It acts on your brain to produce a calming effect.

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About Doral

This medication is used for the short-term treatment of patients with trouble sleeping (insomnia). It is generally used for 7-10 days. It may help you fall asleep faster and decrease the number of times you awaken during the night. It may also help you sleep for a longer period of time. Quazepam belongs to a class of medications called benzodiazepines. It acts on your brain to produce a calming effect.

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 regarding the information, consult your doctor or pharmacist.

Take this medication by mouth, with or without food, usually once nightly, 30 minutes before bedtime; or take as directed by your doctor. 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.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as unusual depressed/anxious mood, stomach/muscle cramps, vomiting, sweating, shakiness, seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used quazepam for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

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 persists or worsens 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 persist or worsen, 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 your doctor has prescribed this medication because he or she 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 any of these unlikely but serious side effects occur: confusion, unusual feelings of well-being (euphoria), uncontrolled movements (tremor), restlessness, memory loss, sweating, mental/mood changes (e.g., hallucinations, agitation, anxiety, unusual/disturbing thoughts, depression, rare thoughts of suicide), increased or vivid dreams, vision changes, fainting.

Tell your doctor right away if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), 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 unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 www.fda.gov/medwatch.

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 (e.g., 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 (e.g., depression, panic disorder), lung problems (e.g., 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.

Quazepam must not be used during pregnancy. Other medications in this class have caused birth defects when used in the first three months of pregnancy. Other medications in this class have also caused unusual drowsiness, feeding problems, and liver problems in newborns when used at or near the time of delivery, or withdrawal symptoms in newborns when used for a long time during pregnancy. If you are a woman of childbearing age, use an effective form of birth control while taking this drug. If you plan to become pregnant, stop taking this drug before doing so. If you become pregnant or think you may be pregnant, inform your doctor right away.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

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.

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.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slurred speech, or a deep sleep from which you cannot be awakened.

Missed Doses:

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.

Notes:

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.

Laboratory and/or medical tests (e.g., liver and kidney function tests, blood count) may be performed periodically to check for side effects if you use this drug for an extended period of time. Consult your doctor for more details.

If you require treatment for more than 7-10 days, laboratory and/or medical tests should be performed 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.

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