Flurazepam
Flurazepam is a benzodiazepine sleep medicine used for the short-term treatment of insomnia, including trouble falling asleep, waking often at night, or waking too early.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Flurazepam (Dalmane) is a benzodiazepine sleep medicine that boosts GABA, the brain's main calming signal, to treat insomnia for short stretches. It has been around since about 1970, is available as a generic, and is now an older standby that prescribers rarely choose first. Because it lingers in the body, next-day drowsiness, dizziness and unsteadiness are what people notice most, sometimes without realizing how impaired they are. Its boxed warning covers dangerously slowed breathing, coma and death when taken with opioids, plus misuse, addiction and dependence, so never stop it suddenly after regular use, because withdrawal can cause seizures.
Clinical pearls
- Take it only when you can stay in bed 7 to 8 hours, and skip driving if you wake up foggy.
- Avoid alcohol completely, and remember its active byproducts linger, so mixing it with other sedatives stays risky for several days after stopping.
- Older or frail adults are especially prone to confusion and falls on this drug, so nighttime trips to the bathroom need extra care.
- If your sleep has not improved after 7 to 10 days, tell your prescriber rather than taking an extra dose.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Flurazepam carries a boxed warning, the FDA's strongest warning, for three main risks.
- Opioids: Taking flurazepam with opioids can cause profound sleepiness, slowed breathing, coma, and death. It should be combined only when no other options work, at the lowest dose and shortest time.
- Abuse, misuse and addiction: Benzodiazepines can lead to overdose or death. The risk is higher when they are used with other medicines, alcohol, or illicit substances.
- Dependence and withdrawal: Your body can become physically dependent, especially with longer use and higher doses. Stopping suddenly or cutting the dose too fast can cause life-threatening withdrawal reactions. A gradual taper helps lower this risk.
Watch for extreme drowsiness, slow or shallow breathing, and trouble waking up.
Patient information guide A plain-language walkthrough of Flurazepam, written from its FDA label.
What Flurazepam is used for
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Flurazepam is used for one condition.
- Flurazepam hydrochloride capsules treat insomnia with trouble falling asleep, frequent waking at night, and/or early morning waking.
- Because insomnia is often short-lived, short-term use is usually enough.
How Flurazepam works
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Flurazepam is a benzodiazepine and a GABA-A agonist. It is thought to bind to specific receptors in the central nervous system (the brain and spinal cord), which calms brain activity and helps with sleep. The exact mechanism is not known.
Flurazepam dosage
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Flurazepam hydrochloride capsules are taken by mouth, usually at bedtime when you can get a full night of sleep. Your prescriber will choose the lowest effective dose, and it may differ for women, men, and older or frail people.
- Take only as directed. Do not take extra.
- Don't stop suddenly after continued use. Use a gradual taper planned with your prescriber.
- Ask your pharmacist or prescriber what to do about a missed dose.
Dosing details from the FDA-approved label
From the Flurazepam prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults (women)
- Recommended initial dose is 15 mg
- The 15 mg dose can be increased to 30 mg if necessary for efficacy
- Use the lowest dose effective for the patient; initial doses differ for women and men because flurazepam clearance is lower in women
- Adults (men)
- Recommended initial dose is either 15 mg or 30 mg
- The 15 mg dose can be increased to 30 mg if necessary for efficacy
- Use the lowest dose effective for the patient; initial doses differ for women and men because flurazepam clearance is lower in women
- Elderly or debilitated patients
- Dosage limited to 15 mg
- Maximum: 15 mg
- Risk of oversedation, dizziness, confusion and/or ataxia increases substantially with larger doses
- Discontinuation or dosage reduction
- Use a gradual taper to discontinue or reduce the dosage
- If withdrawal reactions develop, consider pausing the taper or increasing the dosage to the previous tapered dosage level, then decrease the dosage more slowly
- Gradual taper reduces the risk of withdrawal reactions
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient. Recommended initial dose is 15 mg for women and 15 mg or 30 mg for men. ( 2.1 ) Elderly or debilitated patients: recommended dose is 15 mg. ( 2.2 ) 2.1 Dosage in Adults Use the lowest dose effective for the patient, as important adverse effects of flurazepam hydrochloride capsules are dose related. The recommended initial dose is 15 mg for women and either 15 mg or 30 mg for men. The 15 mg dose can be increased to 30 mg if necessary for efficacy. The recommended initial doses for women and men are different because flurazepam clearance is lower in women [see Pharmacokinetics ( 12.3 ) ]. 2.2 Dosage in Elderly or Debilitated Patients Elderly or debilitated patients may be especially sensitive to flurazepam. Since the risk of the development of oversedation, dizziness, confusion and/or ataxia increases substantially with larger doses in elderly or debilitated patients, it is recommended that in such patients the dosage be limited to 15 mg. Staggering and falling have also been reported, particularly in geriatric patients [see Warnings and Precautions ( 5.2 ) ]. 2.3 Discontinuation or Dosage Reduction of Flurazepam Hydrochloride Capsules To reduce the risk of withdrawal reactions, use a gradual taper to discontinue flurazepam hydrochloride capsules 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 ) ].
Read the full Dosage and Administration section on DailyMed →
Flurazepam side effects
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The most commonly reported effects are related to sedation.
Common side effects
- Dizziness
- Drowsiness
- Light-headedness
- Staggering or poor balance (ataxia)
- Falling
- Headache
- Nausea or upset stomach
- Heartburn
- Heartburn, upset stomach, nausea, vomiting, diarrhea or constipation
- Nervousness, weakness or palpitations (awareness of your heartbeat)
When to get medical help
- Get emergency help for swelling of the tongue, throat or voice box, trouble breathing, or throat closing. These can be signs of a severe allergic reaction.
- Seek help right away for very slow or shallow breathing, extreme sleepiness, or trouble waking up, especially if you also take opioids or alcohol.
- Stop the medicine and call your doctor if you drive, cook, make calls or do other activities while not fully awake and don't remember them.
- Call your doctor about unusual behavior changes, hallucinations, aggression, or agitation.
- Call your doctor if your mood worsens, your depression gets worse, or you have thoughts of suicide.
- Do not stop suddenly. Withdrawal can cause seizures and can be life-threatening.
- Tell your doctor if you feel a growing urge to take more than prescribed or you think you may be misusing it.
- Call your doctor if insomnia hasn't improved after 7 to 10 days, or if it gets worse.
Flurazepam warnings and precautions
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- Opioids: Combining with opioids can cause profound sedation, slowed breathing, coma, and death.
- Abuse, misuse and addiction: These can lead to overdose or death.
- Dependence and withdrawal: Stopping suddenly can cause life-threatening reactions such as seizures. Some people have withdrawal symptoms lasting weeks to over a year.
- Next-day impairment: It can affect alertness and coordination even if you feel fine. Avoid driving and hazardous activities.
- Complex sleep behaviors: Sleep-driving and other actions you don't remember have been reported. Stop the medicine if sleep-driving occurs.
- Allergic reactions: Rare angioedema (swelling) and anaphylaxis have occurred.
- Depression: It may worsen depression.
- Insomnia that persists: If it doesn't improve in 7 to 10 days, an underlying condition may need evaluation.
Flurazepam interactions
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Flurazepam's sedating effects add to those of many other substances.
- Opioids: raises the risk of dangerously slow breathing and death.
- Alcohol: adds to sedation. It generally should not be used.
- Other CNS depressants (other benzodiazepines, tricyclic antidepressants, anticonvulsants, antihistamines, psychotropic medicines): additive drowsiness, and doses may need lowering.
- Other sedative-hypnotics: use together is not recommended.
- Flumazenil: may trigger withdrawal and seizures.
Interactions listed in the FDA-approved label
From the Flurazepam prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Opioids: Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, and death, and benzodiazepines can significantly worsen opioid-related respiratory depression. Limit dosage and duration of concomitant use, and follow patients closely for respiratory depression and sedation.
- CNS depressants (e.g., ethanol, psychotropic medications, anticonvulsants, antihistamines): Benzodiazepines, including flurazepam, produce additive CNS depressant effects when co-administered with ethanol or other CNS depressants. Downward dose adjustment of flurazepam and/or concomitant CNS depressants may be necessary because of additive effects.
Read the label’s full interactions text
7 DRUG INTERACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, and death. ( 7.1 ) CNS Depressants: Downward dose adjustment may be necessary due to additive effects. ( 7.2 ) 7.1 Opioids 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 GABA A 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 follow patients closely for respiratory depression and sedation. 7.2 CNS Depressants Benzodiazepines, including flurazepam, produce additive CNS depressant effects when co-administered with ethanol or other CNS depressants (e.g., psychotropic medications, anticonvulsants, antihistamines). Downward dose adjustment of flurazepam and/or concomitant CNS depressants may be necessary because of additive effects.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Flurazepam
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- Do not use if you are allergic to flurazepam or other benzodiazepines.
- Do not retake it if you ever had tongue or throat swelling after a dose.
- Tell your prescriber about depression, suicidal thoughts, or a history of substance misuse.
- Pregnancy: late use can cause sedation or withdrawal in newborns. Tell your doctor if you are pregnant.
- Breastfeeding is not recommended, since infants have shown sedation and poor feeding with benzodiazepines.
- Children: safety and effectiveness have not been established.
- Older or debilitated adults: more sensitive, with higher risk of confusion, over-sedation and falls. Lower doses are used.
Flurazepam overdose
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Too much flurazepam can cause drowsiness, confusion, slurred speech, weak reflexes, poor coordination, and in severe cases slowed breathing and coma. Combining it with alcohol or opioids can be fatal. Call 911 or Poison Control at 1-800-222-1222 right away. Hospital care is mainly supportive, such as IV fluids and airway management.
What Flurazepam does in the body
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Flurazepam acts as a central nervous system depressant. It helps with falling asleep and staying asleep, but it can also cause daytime drowsiness, slowed reaction time and poor coordination. It can impair you even without obvious symptoms.
How your body processes Flurazepam
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Flurazepam is absorbed quickly from the gut and reaches peak levels about 30 to 60 minutes after a dose. It is rapidly broken down and passed mainly in the urine. Its main active byproduct, desalkyl-flurazepam, lasts a very long time, with a half-life of about 47 to 100 hours, and builds up over 7 to 10 days of dosing. This may be why it often works better on the second or third night, and why effects can linger for a night or two after stopping. Older men clear it more slowly than younger men.
How to store Flurazepam
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Store at 20° to 25°C (68° to 77°F) . Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Flurazepam
99 supplements and herbal products have documented interactions with Flurazepam in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 76
- Minor · 15
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Flurazepam: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Flurazepam — the kind of thing our pharmacy team would talk through with you at the counter.
What is flurazepam for?
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How should I take it?
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What side effects should I expect?
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Can I drink alcohol or take pain medicine with it?
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Is it safe to drive the next day?
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Is it okay during pregnancy or breastfeeding?
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Is Flurazepam available over the counter?
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Is Flurazepam a controlled substance?
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When was Flurazepam first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Flurazepam on HelloPharmacist
Flurazepam forms and strengths (how it comes)
Flurazepam is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Flurazepam inactive ingredients by manufacturer.
Capsule
How this form is used
- Flurazepam Hydrochloride capsules are used to treat insomnia, including trouble falling asleep, frequent night waking, and early morning waking.
- Flurazepam Hydrochloride capsules are taken by mouth, using the lowest dose that works.
- Flurazepam Hydrochloride capsules should be stopped with a gradual taper, not suddenly, after continued use.
- Flurazepam Hydrochloride capsules should be taken only when a full night of sleep (7 to 8 hours) is possible.
Flurazepam on the U.S. market: products, makers and brands
How Flurazepam appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Flurazepam product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1970. Brand names on the directory include Dalmane; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Flurazepam products
A representative set of FDA-listed product records for Flurazepam — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 15 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 30 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Flurazepam NDCs →
Flurazepam side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Flurazepam — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Flurazepam in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Flurazepam FDA approval history
How Flurazepam went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Flurazepam recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Flurazepam recalls since July 2021.
✅No Flurazepam recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4501 1 dose form · 2 strengths
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Dose form (SCDF) Oral Capsule RxCUI 372243In current FDA listings
Look up RxCUI 4501 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Flurazepam supply and shortage status
Whether Flurazepam is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Flurazepam brand names
Flurazepam is sold under one brand name in the FDA directory — Dalmane. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Flurazepam: manufacturers and labelers
One company lists Flurazepam products with the FDA. By number of product records, the largest are Chartwell RX, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Flurazepam drug class (RxNorm)
Flurazepam belongs to the Benzodiazepine class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Flurazepam page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Chartwell RX, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →