Flurazepam First approved as Dalmane

What is flurazepam used for?

From the label: indications and usage

Flurazepam hydrochloride capsules are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings [see Clinical Studies ( 14 ) ]. Since insomnia is often transient and intermittent, short-term use is usually sufficient. Prolonged use of hypnotics is usually not indicated and should only be undertaken concomitantly with appropriate evaluation of the patient. Flurazepam, a gamma-aminobutyric (GABA A ) agonist, is indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

Conditions named in the indications of flurazepam's FDA labels, with every medicine labeled for each:

• Insomnia

FDA pharmacologic class: Benzodiazepine.

What does the patient leaflet for flurazepam say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about flurazepam hydrochloride capsules?

Flurazepam hydrochloride capsules are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation). Do not drive or operate heavy machinery until you know how taking flurazepam hydrochloride capsules with opioids affect you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including flurazepam hydrochloride capsules, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including flurazepam hydrochloride capsules. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. You can develop an addiction even if you take flurazepam hydrochloride capsules exactly as prescribed by your healthcare provider. Take flurazepam hydrochloride capsules exactly as your healthcare provider prescribed. Do not share your flurazepam hydrochloride capsules with other people. Keep flurazepam hydrochloride capsules in a safe place and away from children. Physical dependence and withdrawal reactions. […]

From the patient leaflet: How should I store flurazepam hydrochloride capsules?

Store at 20° to 25°C (68° to 77°F). Keep flurazepam hydrochloride capsules in a tightly closed container and out of the light. Keep flurazepam hydrochloride capsules and all medicines out of the reach of children.

Is there a generic for flurazepam (Dalmane)?

The FDA approved the first generic flurazepam on June 12, 1985. 17 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists flurazepam from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

Is flurazepam in shortage?

The FDA Drug Shortage Database lists 2 of 6 flurazepam presentations as limited or unavailable (updated September 15, 2026); the first entry was posted on August 3, 2022. 4 more presentations are on the list as available.

Every flurazepam presentation in the FDA shortage database

What does the flurazepam label say about other medicines?

The flurazepam label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 9 other medicines name flurazepam. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Other labels that name flurazepam

• Buspirone
• Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide
• Cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil
• Fosamprenavir
• Ritonavir

Check flurazepam against other medicines

What do FAERS reports show for flurazepam?

The FDA Adverse Event Reporting System holds 395 reports that list flurazepam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 43 are coded as a death and 205 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

• Drug Abuse65
• Suicide Attempt55
• Sopor51
• Toxicity To Various Agents49
• Intentional Overdose (a use or a product term, not a reaction)44
• Intentional Self-Injury39
• Somnolence35
• Drug Interaction (a use or a product term, not a reaction)27

Side effects: the label's list and every FAERS reaction

What else is labeled for the same conditions as flurazepam?

11 other medicines are given the same way (oral) and in the same FDA class as flurazepam or labeled mainly for the same use (insomnia), the same class first. Insomnia lists all 14 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Every medicine labeled for the same conditions as flurazepam

What next?

Alternatives to flurazepam

11 medicines for the same use

Other benzodiazepines

the pharmacologic class, with prices and generics

Flurazepam side effects

the label's list beside FAERS reports

Flurazepam shortage record

every presentation, company and date

Check an interaction

what two or more labels say about each other