Doral can cause severe drowsiness, difficulty breathing, coma, and even death if taken with opioid pain medicines. Only use these medicines together if other treatments have failed.
There is a risk of abuse, misuse, and addiction with benzodiazepine drugs, including Doral. This increases your chance of overdosing and having serious, life-threatening side effects.
You may become physically dependent on Doral. Withdrawal reactions, which may be serious and life-threatening, can occur if you stop taking Doral abruptly. Withdrawal symptoms can last several weeks to more than 12 months. Talk to your provider about the best way to stop Doral.
Doral is a controlled substance because it contains quazepam, which can be abused or lead to dependence.
What Is Doral Used For?
The Food and Drug Administration (FDA) approved Doral to treat insomnia (trouble sleeping) in adults. Insomnia can involve trouble falling asleep, waking up frequently throughout the night, or waking up too early in the morning.
Brand Name: Doral
Drug Availability: Prescription
Therapeutic Classification: Benzodiazepine
Available Generically: No
Controlled Substance: Schedule 4
Administration Route: Oral
Active Ingredient: Quazepam
Dosage Form: Tablet
The FDA has issued several boxed warnings (the agency’s strongest warning) for Doral. Discuss these risks with your healthcare provider before starting treatment:
Doral can cause severe drowsiness, difficulty breathing, coma, and even death if taken with opioid pain medicines. Only use these medicines together if other treatments have failed. There is a risk of abuse, misuse, and addiction with benzodiazepine drugs, including Doral. This increases your chance of overdosing and having serious, life-threatening side effects. You may become physically dependent on Doral. Withdrawal reactions, which may be serious and life-threatening, can occur if you stop taking Doral abruptly. Withdrawal symptoms can last several weeks to more than 12 months. Talk to your provider about the best way to stop Doral.
Doral is also classified as a schedule 4 controlled substance. It’s important to keep this medication in a safe place to prevent misuse and abuse. It is illegal to sell or give away Doral.
How to Take Doral
Doral should be taken at bedtime, right before you get into bed. Only take Doral if you can get a full night’s sleep (at least seven to eight hours) before you need to be active again.
Doral comes as 15 milligram (mg) tablets. Your healthcare provider may recommend starting with a 7.5 mg dose, which is half a tablet. You will need to split the 15 mg tablet to take this dose.
The best way to cut a tablet is with a pill splitter. Using a knife or scissors could result in unequal parts. Pill splitters are inexpensive and available at most pharmacies. Ask your pharmacist to show you how to use a pill splitter if you are unsure.
Storage
Doral should be stored at room temperature (about 68–77 degrees Fahrenheit).
Doral is a controlled substance and can be abused. Keep this medication stored in a safe place, up high and out of reach of children.
What Are the Side Effects of Doral?
Doral may cause side effects, especially the day after taking it. Do not drive or perform any activity that requires your full attention until you know how Doral will affect you.
This is not a complete list of side effects and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.
Common Side Effects
The most common side effects of Doral include:
DizzinessDrowsiness Dry mouth Feeling very tiredHeadacheUpset stomach
Severe Side Effects
Doral may cause serious and sometimes life-threatening side effects. Call your healthcare provider right away if you develop any severe side effects. Call 911 if your symptoms feel life-threatening or you think you are having a medical emergency.
Serious side effects and their symptoms include:
Severe drowsiness, trouble breathing (shallow or slow breathing), coma, and death, especially if used with opioid pain medications, alcohol, or other sedating drugs. Abusing or misusing Doral can lead to serious side effects, including coma and death. Take Doral exactly as your doctor has prescribed. Other serious side effects from abusing or misusing Doral include delirium (severe confusion), difficulty breathing, paranoia, seizures, and suicidal thoughts or actions. Withdrawal reactions, which can sometimes be serious and life-threatening. Talk to your provider before stopping Doral. Serious withdrawal reactions can include depression, mania, hallucinations, unusual and uncontrollable movements, and suicidal thoughts or actions. Next-day sleepiness, dizziness, slowed thinking, and trouble performing activities, especially if you take Doral with alcohol or other medications that make you sleepy. Do not drive or perform any activity that requires your full attention until you know how Doral affects you. Severe allergic reactions. Get medical help right away if you develop swelling of the tongue or throat, trouble breathing, and nausea or vomiting. Performing activities while not fully awake, especially if you drink alcohol or take other sedating drugs with Doral. After taking Doral, some people may perform activities that they don’t remember the next day. These include driving (“sleep-driving”), having sex, making phone calls, preparing and eating food, and sleepwalking. Worsening of depression symptoms in people with a history of depression Abnormal thoughts or behaviors, such as feeling confused or agitated, feeling more outgoing or aggressive than normal, or hallucinations.
Long-Term Side Effects
After stopping Doral, you may experience withdrawal reactions that can last for a few weeks to more than 12 months. People who take higher doses or take Doral for longer periods are at an increased risk of these reactions. You may experience:
A burning or prickling feeling in your hands, arms, legs, or feet Anxiety Depression Feeling like bugs are crawling on or under your skin Memory problems Muscle twitching Problems sleeping Ringing in your ears (tinnitus) Shaking Trouble learning or concentrating Weakness
Be sure to discuss the best way to stop Doral with your provider. They may recommend slowly decreasing your dose to help prevent withdrawal reactions.
How Much Doral Should I Take?
Modifications
Doral may cause confusion and extreme sleepiness in older adults (aged 65 years and older). This can increase the risk of falls and injuries. Healthcare providers may prescribe a lower dose of Doral for older adults.
If you experience a serious side effect, you or your provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
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 forget to take your dose of Doral, take it as soon as you remember. However, if it’s too late in the night and you won’t be able to get at least seven to eight hours of sleep, skip your dose and wait until the next night. Taking Doral without enough time to sleep can cause excessive daytime sleepiness and impair your functioning the next day.
Overdose: What Happens If I Take Too Much Doral?
Taking more than your prescribed dose of Doral may result in extreme sleepiness, confusion, and even coma. It’s important to take Doral exactly as prescribed and never share your prescription with someone else.
Precautions
What Are Reasons I Shouldn’t Take Doral?
Certain conditions can increase your chance of developing complications from Doral. Do not take Doral if you have sleep apnea (a sleep disorder in which breathing repeatedly stops and starts during the night) or breathing or lung problems.
If someone collapses or isn’t breathing after taking Doral, call 911 immediately.
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, including hallucinations, seizures, 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.
Symptoms of an overdose include: change in consciousness, loss of consciousness, mood or mental changes, or sleepiness or unusual drowsiness. Call your doctor right away if you notice these symptoms.
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.
Let your healthcare provider know about all your allergies. Do not take Doral if you are allergic to quazepam or any other ingredient in Doral. Do not take Doral if you have had an allergic reaction to other benzodiazepines, like Xanax (alprazolam), Restoril (temazepam), or Klonopin (clonazepam).
What Other Medications Interact With Doral?
Taking certain medications with Doral can increase your chance of developing side effects. Be sure to let your provider know about all medicines you take, including over-the-counter, nonprescription products, and supplements.
Doral can interact with the following:
Alcohol Antihistamines like Benadryl (diphenhydramine) and chlorpheniramine Certain antidepressants and antipsychotic medications Certain anti-seizure medications Opioid pain medicines like oxycodone (found in OxyContin, Percocet), hydrocodone (found in Vicodin), and methadone Other benzodiazepines like Xanax (alprazolam), Restoril (temazepam), or Klonopin (clonazepam) Other sleep medications like Ambien (zolpidem), Lunesta (eszopiclone), and Sonata (zaleplon)
Many other drugs can interact with Doral. Always keep an up-to-date list of all the medicines you take, and let your doctor and pharmacist know any time there are changes.
What Medications Are Similar?
Other benzodiazepine medicines (like Doral) are used to treat insomnia. Compared to these other drugs, Doral may cause less rebound insomnia—worsening of your insomnia symptoms after you stop taking a sleep medicine. You may also be less likely to perform activities while not fully awake (e.g., sleep-driving, sleepwalking, sex). However, Doral may cause more next-day sleepiness.
Other benzodiazepines used to treat insomnia include:
Prosom (estazolam)Dalmane and Daladorm (flurazepam) Halcion (triazolam) Restoril (temazepam)
This is a list of benzodiazepines also used to treat insomnia. It is not a list of drugs recommended to take with Doral. In fact, you should not take these drugs together. Ask your doctor or pharmacist if you have any questions about your medications.
How Can I Stay Healthy While Taking Doral?
If you’ve been having a hard time getting a good night’s sleep, Doral may be able to help. Healthcare providers often recommend nondrug treatments for insomnia first, like improving sleep hygiene. But for some people, it’s not enough.
If you’ve been prescribed Doral, be sure to take it exactly as instructed. Don’t drink alcohol or take other drugs that make you sleepy while taking Doral. Because Doral can cause next-day sleepiness, don’t drive or perform any activity that requires your full attention until you know how Doral affects you. Following these precautions can help keep you safe and healthy.
