Doral

Name: Doral

What Is Quazepam?

Quazepam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Quazepam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia).

Quazepam is used to treat insomnia symptoms, such as trouble falling or staying asleep.

Quazepam may also be used for other purposes not listed in this medication guide.

Quazepam may cause a severe allergic reaction. Stop taking quazepam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Take quazepam only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking quazepam and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to quazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), or triazolam (Halcion).

This medication can cause birth defects in an unborn baby, or withdrawal symptoms in a newborn. Do not use quazepam if you are pregnant.

Before taking quazepam, tell your doctor if you have any breathing problems, kidney or liver disease, or a history of depression, mental illness, suicidal thoughts, or addiction to drugs or alcohol.

Quazepam may be habit-forming and should be used only by the person it was prescribed for. Quazepam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Quazepam should be used for only a short time to treat insomnia. After 7 to 10 nights of use, talk with your doctor about whether or not you should keep taking quazepam.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking quazepam and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to quazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), or triazolam (Halcion).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take quazepam.

  • asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
  • kidney or liver disease;
  • a history of depression, mental illness, suicidal thoughts or behavior; or
  • a history of drug or alcohol addiction.

FDA pregnancy category X. Quazepam can cause birth defects in an unborn baby. It may also cause withdrawal symptoms in a newborn if the mother takes quazepam during pregnancy. Do not use quazepam if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

Quazepam can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The sedative effects of quazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking quazepam.

Do not give this medication to anyone under 18 years old.

Pregnancy & Lactation

Pregnancy Category: D

Lactation: Avoid if breastfeeding

Minor tranquilizers should be avoided in 1st trimester of pregnancy due to increased risk of congenital malformations

Maternal use shortly before delivery is associated with floppy infant syndrome (good and consistent evidence)

Prenatal benzodiazepine exposure slightly increased oral cleft risk (limited or inconsistent evidence)

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Side Effects of Doral

Serious side effects have been reported with Doral. See the "Doral Precautions" section.

Common side effects of Doral include the following:

  • dizziness
  • drowsiness
  • tiredness the next day
  • headache
  • dry mouth
  • feeling tired
  • dyspepsia (indigestion) and/or upset stomach

This is not a complete list of Doral side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What is quazepam (doral)?

Quazepam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Quazepam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia).

Quazepam is used to treat insomnia symptoms, such as trouble falling or staying asleep.

Quazepam may also be used for other purposes not listed in this medication guide.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

What other drugs will affect Doral (quazepam)?

Small amounts of quazepam can remain in your body for several days after you stop taking it. Other medicines you use during that time may cause drug interactions.

Taking quazepam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with quazepam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Proper Use of Doral

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take quazepam just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.

Use this medicine only when you cannot sleep. You do not need to keep a regular dosage schedule for taking it. Do not use two doses at the same time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For insomnia (trouble in sleeping):
      • Adults and older adults—At first, 7.5 milligrams (mg) (half-tablet) at bedtime. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Uses of Doral

  • It is used to treat sleep problems.

For Healthcare Professionals

Applies to quazepam: oral tablet

General

The most frequently reported side effects included daytime drowsiness, headache, fatigue, dizziness, dry mouth, and dyspepsia.

Nervous system

Very common (10% or more): Daytime drowsiness (12%)
Common (1% to 10%): Headache, fatigue, dizziness

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Gastrointestinal

Common (1% to 10%): Dry mouth, dyspepsia[Ref]

Some side effects of Doral may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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