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Doral

Last reviewed on RxList: 10/31/2016
Doral Side Effects Center

Last reviewed on RxList 2/23/2016

Doral (quazepam) is a benzodiazepine used to treat insomnia symptoms, such as trouble falling or staying asleep. Common side effects of Doral include dizziness, spinning sensation (vertigo), loss of balance or coordination, blurred vision or other vision problems, daytime drowsiness (or during hours when you are not normally sleeping), amnesia or forgetfulness, confusion, muscle weakness, insomnia or nightmares, headache, depression, nervousness, excitement, irritability, impotence, loss of interest in sex, itching or skin rash, nausea, diarrhea, stomach pain, loss of appetite, dry mouth, or increased thirst.

The initial adult dose of Doral is 15 mg. In some patients, the dose may be reduced to 7.5 mg. Doral may interact with other medications that cause drowsiness (such as cold or allergy medicine, sedatives, narcotics, muscle relaxers, and medicine for seizures, depression or anxiety), bupropion, cyclophosphamide, efavirenz, irinotecan, promethazine, or selegiline. Tell your doctor all medications and supplements you use. Doral must not be used during pregnancy. Other medications in this class have caused birth defects when used in the first three months of pregnancy, and 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. Women should use birth control while taking this drug. If you become pregnant or think you may be pregnant, inform your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding while using this drug is not recommended. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Our Doral (quazepam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Doral Consumer Information

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.

Stop using quazepam and call your doctor at once if you have a serious side effect such as:

  • worsening insomnia;
  • confusion, anxiety, slurred speech, unusual thoughts or behavior;
  • hallucinations, agitation, aggression;
  • weak or shallow breathing;
  • fast or pounding heartbeats;
  • muscle stiffness in your tongue, jaw, or neck;
  • problems with urination; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • daytime drowsiness (or during hours when you are not normally sleeping);
  • amnesia or forgetfulness;
  • muscle weakness, lack of balance or coordination;
  • dizziness, vision problems;
  • nightmares;
  • headache, blurred vision, depressed mood;
  • feeling nervous, excited, or irritable;
  • impotence, loss of interest in sex;
  • mild itching or skin rash;
  • nausea, diarrhea, stomach pain, loss of appetite; or
  • dry mouth, increased thirst.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Doral (Quazepam Tablets)

Doral Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

  • CNS-depressant effects and next-day impairment [see WARNINGS AND PRECAUTIONS]
  • Benzodiazepine withdrawal syndrome[see WARNINGS AND PRECAUTIONS]
  • Abnormal thinking and behavior changes, and complex behaviors[see WARNINGS AND PRECAUTIONS]
  • Worsening of depression[see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The table shows adverse reactions occurring at an incidence of 1% or greater in relatively short-duration, placebo-controlled clinical trials of Doral. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in actual practice.

  DORAL 15 mg PLACEBO
NUMBER OF PATIENTS 267 268
  % OF PATIENTS REPORTING
Central Nervous System
  Daytime Drowsiness 12 3
  Headache 5 2
  Fatigue 2 0
  Dizziness 2 < 1
Autonomic Nervous System
  Dry Mouth 2 < 1
Gastrointestinal System
  Dyspepsia 1 < 1

A double-blind, controlled sleep laboratory study (N=30) in elderly patients compared the effects of quazepam 7.5 mg and 15 mg to that of placebo over a period of 7 days. Both the 7.5 mg and 15 mg doses appeared to be well tolerated. Caution must be used in interpreting this data due to the small size of the study.

Read the entire FDA prescribing information for Doral (Quazepam Tablets)

Related Resources for Doral

Read the Doral User Reviews »

© Doral Patient Information is supplied by Cerner Multum, Inc. and Doral Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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