Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Doral

Descriptions


Quazepam is used to treat insomnia (trouble sleeping). This medicine is for short-term (usually 7 to 10 days) use only. Quazepam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of quazepam in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of quazepam in the elderly. However, elderly patients are more likely to have confusion, dizziness, or falls and age-related heart, liver, or kidney problems which may require an adjustment in the dose for patients receiving quazepam.

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.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Flumazenil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alfentanil
  • Amobarbital
  • Benzhydrocodone
  • Bromazepam
  • Bromopride
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Calcium Oxybate
  • Cannabidiol
  • Carbinoxamine
  • Carisoprodol
  • Cetirizine
  • Chloral Hydrate
  • Chlorzoxazone
  • Clobazam
  • Codeine
  • Dantrolene
  • Dihydrocodeine
  • Doxylamine
  • Esketamine
  • Ethchlorvynol
  • Fentanyl
  • Flibanserin
  • Gabapentin
  • Gabapentin Enacarbil
  • Hydrocodone
  • Hydromorphone
  • Ketamine
  • Lemborexant
  • Levocetirizine
  • Levorphanol
  • Lofexidine
  • Loxapine
  • Magnesium Oxybate
  • Meclizine
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Metoclopramide
  • Midazolam
  • Mirtazapine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Pentobarbital
  • Periciazine
  • Phenobarbital
  • Potassium Oxybate
  • Pregabalin
  • Primidone
  • Remimazolam
  • Scopolamine
  • Secobarbital
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Thiopental
  • Tramadol
  • Trazodone
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Rifapentine
  • St John's Wort
  • Theophylline

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, history of or
  • Breathing problems or lung disease or
  • Depression or
  • Drug abuse or dependence, history of
  • Mental health problems—Use with caution. May make these conditions worse.
  • Pulmonary insufficiency or
  • Sleep apnea (temporary stopping of breathing during sleep)—Should not be used in patients with these conditions.

Proper Use

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.

Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

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:
      • 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, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

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.

Precautions

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to allow for changes in the dose.

If your condition does not improve within 7 to 10 days, or if it becomes worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Quazepam may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, nausea or vomiting, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth or throat while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or seizures medicine, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy or less alert than they are normally, which may lead to falls. Even though quazepam is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not stop using this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

This medicine may cause you to do things while you are still asleep that you may not remember the next morning. It is possible you could drive a car, sleepwalk, have sex, make phone calls, or prepare and eat food while you are asleep or not fully awake. Tell your doctor right away if you learn that any of these has happened.

If you develop any unusual and strange thoughts or behavior while you are taking quazepam, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of quazepam or taking alcohol or other CNS depressants with quazepam may lead to serious breathing problems and unconsciousness. Some signs of an overdose include: severe drowsiness, severe nausea or vomiting, staggering, and troubled breathing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Drowsiness

Less common

  1. Dizziness

Rare

  1. Anxiety
  2. dry mouth
  3. hyperventilation
  4. increased muscle spasm
  5. irregular heartbeats
  6. irritability
  7. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  8. nightmares
  9. restlessness
  10. shaking
  11. trouble breathing
  12. unusual excitement, nervousness, restlessness, or irritability

Incidence not known

  1. Changes in patterns and rhythms of speech
  2. chills
  3. clay-colored stools
  4. dark urine
  5. decrease in frequency of urination
  6. decrease in urine volume
  7. difficulty in passing urine (dribbling)
  8. fever
  9. headache
  10. inability to move the eyes
  11. increased blinking or spasms of the eyelid
  12. itching or rash
  13. loss of appetite
  14. loss of bladder control
  15. nausea
  16. painful urination
  17. seizures
  18. shakiness in the legs, arms, hands, or feet
  19. slurred speech
  20. sticking out of the tongue
  21. stomach pain
  22. trembling or shaking of the hands or feet
  23. trouble in speaking or swallowing
  24. uncontrolled twisting movements of the neck, trunk, arms, or legs
  25. unpleasant breath odor
  26. unusual facial expressions
  27. unusual tiredness or weakness
  28. vomiting of blood
  29. yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Change in consciousness
  2. loss of consciousness
  3. mood or mental changes
  4. sleepiness or unusual drowsiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Belching
  2. heartburn
  3. indigestion
  4. stomach discomfort or upset

Incidence not known

  1. Decreased interest in sexual intercourse
  2. inability to have or keep an erection
  3. increase in sexual ability, desire, drive, or performance
  4. increased interest in sexual intercourse
  5. loss in sexual ability, desire, drive, or performance
  6. menstrual changes
  7. sweating
  8. vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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