MedeliX
Start asking

Flurazepam

ATC code N05CD01

Key facts
Active substance
Flurazepam
Drug class
Benzodiazepine drug
ATC code
N05CD01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions ( 5.1) and Drug Interactions ( 7.1) ].
  • The use of benzodiazepines, including flurazepam hydrochloride capsules, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing flurazepam hydrochloride capsules, and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [ see Warnings and Precautions ( 5.2) ].
  • The continued use of benzodiazepines, including flurazepam hydrochloride capsules, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of flurazepam hydrochloride capsules after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue flurazepam hydrochloride capsules or reduce the dosage [ see Dosage and Administration ( 2.3) and Warnings and Precautions ( 5.3) ].

Key facts

Flurazepam is, per the US prescribing information, a benzodiazepine hypnotic used to treat insomnia with difficulty falling asleep, frequent nocturnal awakenings and/or early morning awakenings.

What it is used for

  • Insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings and/or early morning awakenings.
  • Short-term use is usually sufficient; prolonged use is usually not indicated and requires appropriate evaluation.

Dosing

  • Use the lowest effective dose, as important adverse effects are dose related.
  • Initial dose: women 15 mg, men 15 mg or 30 mg; 15 mg may be increased to 30 mg if needed (clearance is lower in women).
  • Elderly or debilitated patients: limit the dose to 15 mg.
  • Use a gradual taper when stopping or reducing the dose to lower the risk of withdrawal reactions.

Contraindications

  • Known hypersensitivity to flurazepam or other benzodiazepines; do not rechallenge after angioedema.

Important warnings

  • Boxed warning: use with opioids may cause profound sedation, respiratory depression, coma and death; risks of abuse, misuse and addiction that can lead to overdose or death; physical dependence with potentially life-threatening withdrawal reactions after abrupt discontinuation.
  • CNS depression and next-day impairment (even without subjective symptoms); risk is higher with less than 7 to 8 hours of sleep remaining; higher risk of falls, especially in the elderly.
  • Complex behaviors such as sleep-driving, abnormal thinking and behavior, hallucinations and paradoxical reactions.
  • Rare severe anaphylactic reactions and angioedema of the tongue, glottis or larynx.
  • May worsen depression; insomnia that persists after 7 to 10 days may indicate another illness.

Side effects

  • Common: dizziness, drowsiness, light-headedness, staggering, ataxia and falling, particularly in elderly or debilitated persons.
  • Others: headache, heartburn, upset stomach, nausea, vomiting, diarrhea, constipation, nervousness, irritability, weakness, palpitations.
  • Rare: leukopenia, granulocytopenia.

Interactions

  • Opioids: increased risk of respiratory depression; limit dose and duration and follow patients closely.
  • Alcohol and other CNS depressants (e.g. psychotropics, anticonvulsants, antihistamines) have additive effects; alcohol should generally be avoided and other sedative-hypnotics are not recommended.

Pregnancy and breastfeeding

  • Use late in pregnancy can cause sedation and withdrawal symptoms in the neonate.
  • Infants exposed to benzodiazepines through breast milk have shown sedation and poor feeding; given the long half-life, accumulation is possible.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Germany

  • Flurazepam RealEsteve Pharmaceuticals Gmbh · 1 register entry
  • Staurodorm NeuEsteve Pharmaceuticals Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Brand names in 2 more European countries
Belgium
Staurodorm
Portugal
Morfex

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Flurazepam Hydrochloride (Chartwell RX, LLC) – Prescribing Information, 2024-10-28. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f476891-1346-4e8c-ac1b-f8cbdc64f5a1
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. Wikidata (CC0): ATC N05CD.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.