Quazepam: uses, dosing, side effects & brands
Quazepam is a benzodiazepine sold in the U.S. under one brand, for sleep initiation and maintenance disorders. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Benzodiazepine
- Treats
- Sleep Initiation and Maintenance Disorders
- Available as
- Tablet
- Sold as
- Doral
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How quazepam is dosed
From the FDA label for Doral (application NDA018708). Other quazepam products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Use the lowest dose effective for the patient: Recommended initial dose is 7.5 mg ( 2 ) Split the 15 mg tablet along the score line to achieve 7.5 mg dose ( 2 ) The elderly and debilitated may be more sensitive to benzodiazepines ( 2 ) 2.1 Dosage Recommendations Use the lowest dose effective for the patient, as important adverse effects of Quazepam Tablets are dose related. The recommended initial dose is 7.5 mg. The 7.5 mg dose can be increased to 15 mg if necessary for efficacy. The 7.5 mg dose can be achieved by splitting the 15 mg tablet along the score line. 2.2 Special Populations Elderly and debilitated patients may be more sensitive to benzodiazepines. 2.3 Discontinuation or Dosage Reduction of Quazepam Tablets To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Quazepam Tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see Warnings and Precautions ( 5.3 ) and Drug Abuse and Dependence ( 9.3 )] .
Quazepam side effects
The following serious adverse reactions are discussed in greater detail in other sections of the label: Risks from Concomitant Use with Opioids [see Warnings and Precautions ( 5.1 )] Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.2 )] Dependence and Withdrawal Reactions [see Warnings and Precautions ( 5.3 )] CNS-depressant effects and next-day impairment [see Warnings and Precautions ( 5.4 )] Abnormal thinking and behavior changes, and complex behaviors [see Warnings and Precautions ( 5.7 )] Worsening of depression [see Warnings and Precautions ( 5.8 )] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>1%): drowsiness, headache, fatigue, dizziness, dry mouth, dyspepsia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Atland Pharmaceuticals at 1-844-416-4284 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . ( 6 ) 6.1 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 Quazepam Tablets. Quazepam Tablets 15 mg PLACEBO…
Who shouldn’t take quazepam
Quazepam Tablets are contraindicated in patients with known hypersensitivity to quazepam or other benzodiazepines. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of Quazepam Tablets. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Patients who develop such reactions should not be rechallenged with Quazepam Tablets. Contraindicated in patients with established or suspected sleep apnea, or with pulmonary insufficiency. Hypersensitivity to Quazepam Tablets or other benzodiazepines ( 4 ) Established or suspected sleep apnea, or chronic pulmonary insufficiency ( 4 )
Quazepam drug interactions
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. Benzodiazepines, including Quazepam Tablets, produce additive CNS depressant effects when co-administered with ethanol or other CNS depressants (e.g. psychotropic medications, anticonvulsants, antihistamines). Downward dose adjustment of Quazepam Tablets and/or concomitant CNS depressants may be necessary because of additive effects. CNS Depressants: downward dose adjustment may be necessary due to additive effects ( 7 )
Every quazepam product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Doral.
What quazepam pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 15;DORAL | 15 mg | orange | capsule | — |
Quazepam and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for quazepam: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the long-term use of quazepam during breastfeeding. Because the drug and metabolites could accumulate in the breastfed infant, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised January 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about quazepam
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 312 reports naming quazepam, and the FDA flagged 91% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- altered state of consciousness26 reports
- hypoglycaemia18 reports
- pyrexia17 reports
- nausea15 reports
- somnolence15 reports
- fall14 reports
- blood creatine phosphokinase increased13 reports
- delirium13 reports
Read these as a signal, not a rate. A report does not mean quazepam caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is quazepam?
Doral (Quazepam) is a benzodiazepine used to treat Sleep Initiation and Maintenance Disorders.
What kind of drug is quazepam?
The FDA classifies quazepam as a benzodiazepine. Benzodiazepines boost the brain's main calming chemical, GABA, by binding to the GABA-A receptor and making its chloride channel open more often. This quiets nerve activity, producing sedation, reduced anxiety, muscle relaxation, and protection against seizures. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take quazepam with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run quazepam against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does quazepam come in?
Across the brands we track, quazepam is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic quazepam?
We do not currently list a generic-labelled quazepam product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Quazepam: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/quazepam
- MLA
- “Quazepam: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/quazepam.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for quazepam on DailyMed (NIH) ↗ — including its boxed warning in full.