Doral
Doral (Quazepam Tablets) side effects drug center
Doral Side Effects Center
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.
Doral Consumer Information
Quazepam may cause a severe allergic reaction. Stop taking quazepam and get emergency medical help if you have signs of an allergic reaction: hives; nausea and vomiting; snoring, difficulty breathing; swelling of your face, lips, tongue, or throat.
Quazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.
Call your doctor at once if you have:
- confusion, agitation, hallucinations;
- unusual thoughts or behavior;
- suicidal thoughts; or
- worsening depression.
Some people using quazepam have engaged in activity such as driving, eating, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.
The sedative effects of quazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines.
Common side effects may include:
- daytime drowsiness;
- headache, dizziness;
- feeling very tired;
- upset stomach; or
- dry mouth.
For 1 to 2 days after you stop taking quazepam, you may have side effects such as:
- trouble sleeping;
- panic attacks, feeling nervous or light-headed;
- uncontrolled crying;
- nausea, vomiting, stomach pain; or
- flushing (sudden warmth, redness, or tingly feeling).
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 practice. The table shows adverse reactions occurring at an incidence of 1% or greater in relatively short-duration, placebo-controlled clinical trials of DORAL.
| NUMBER OF PATIENTS | DORAL 15 mg | PLACEBO |
| 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 DORAL 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)
&Copy; 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.