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Clobazam

Clobazam Essential Pharmaceuticals · ATC code N05BA09

Also known as: Klobazam · Brand names: Clobazam Essential Pharmaceuticals, Clobazam Desitin, Clobazam Micro Labs, Clobazam Syri Pharma, Epaclob, Frisium, Genobaz, Sympazan

Key facts
Active substance
Clobazam
Drug class
Benzodiazepine drug
ATC code
N05BA09
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 SYMPAZAN, 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 SYMPAZAN 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 SYMPAZAN, 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 SYMPAZAN 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 SYMPAZAN or reduce the dosage [see Dosage and Administration (2.2) and Warnings and Precautions (5.3)].

Key facts

Clobazam is a benzodiazepine antiepileptic, here as an oral film. Per the US prescribing information, it is used as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 2 years of age or older.

What it is used for

  • Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older

Dosing

  • Dose by body weight; daily doses above 5 mg are given in two divided doses
  • 30 kg or less: start 5 mg/day, 10 mg from day 7, 20 mg from day 14; more than 30 kg: start 10 mg/day, 20 mg from day 7, 40 mg from day 14
  • Do not increase the dose more rapidly than weekly
  • Elderly patients, CYP2C19 poor metabolizers and mild to moderate hepatic impairment (Child-Pugh 5-9): start at 5 mg/day and titrate to half the usual doses – see the full text; no recommendation for severe hepatic impairment
  • Discontinue by gradual taper: reduce the total daily dose by 5-10 mg/day weekly
  • The film is placed on top of the tongue to dissolve; do not take with liquids

Contraindications

  • History of hypersensitivity to the drug or its ingredients, including serious skin reactions

Important warnings

  • Boxed warning: concomitant use with opioids may cause profound sedation, respiratory depression, coma and death
  • Boxed warning: risk of abuse, misuse and addiction, which can lead to overdose or death
  • Boxed warning: physical dependence; abrupt discontinuation or rapid dose reduction may cause life-threatening withdrawal reactions
  • Somnolence or sedation, increased by other CNS depressants and alcohol
  • Serious skin reactions (including SJS/TEN) and DRESS
  • Suicidal behavior and ideation; neonatal sedation and withdrawal syndrome

Side effects

  • Most common in the controlled study (all doses): somnolence or sedation (26%), pyrexia (13%), upper respiratory tract infection (12%), lethargy (10%) and drooling (9%)
  • Also: aggression, vomiting, irritability, constipation, ataxia, insomnia, cough
  • Serious: respiratory depression, skin reactions, DRESS, suicidal thoughts

Interactions

  • Opioids: risk of respiratory depression – limit dose and duration
  • Other CNS depressants and alcohol: increased sedation
  • Hormonal contraceptives may be less effective (weak CYP3A4 induction); additional non-hormonal contraception is recommended
  • Strong or moderate CYP2C19 inhibitors (e.g. fluconazole, fluvoxamine, ticlopidine) increase exposure to the active metabolite; dose adjustment may be necessary
  • Clobazam inhibits CYP2D6; drugs metabolized by CYP2D6 may need dose adjustment

Pregnancy and breastfeeding

  • Use late in pregnancy may cause sedation and withdrawal symptoms in the newborn; animal studies showed developmental toxicity
  • A pregnancy exposure registry for antiepileptic drugs exists

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 →

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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.

Austria

  • Clobazam Essential PharmaceuticalsEssential Pharmaceuticals Limited · 1 register entry

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

Germany

  • Clobazam DesitinDesitin Arzneimittel Gmbh · 1 register entry
  • Clobazam Micro LabsMicro Labs Gmbh · 1 register entry
  • Clobazam Syri PharmaSyri Pharma Limited · 1 register entry
  • EpaclobEthypharm · 1 register entry
  • FrisiumAtnahs Pharma Netherlands B.V. · 2 register entries

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

Turkey

  • GenobazGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • SympazanAquestive Therapeutics · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 18 more European countries
Belgium
Clobazam Essential Pharmaceuticals, Frisium
Cyprus
Frisium
Czechia
Frisium
Denmark
Clobazam Brown & Burk Ir Limited, Clobazam Essential Pharmaceuticals, Frisium, Silocalm
Finland
Clobazam Essential Pharmaceuticals
France
Likozam, Urbanyl
Greece
Frisium
Hungary
Frisium
Ireland
Clobazam Brown & Burk, Clobazam Essential Pharmaceuticals, Clobazam Thame, Epaclob, Frisium
Italy
Epaclob, Frisium
Luxembourg
Clobazam Essential Pharmaceuticals, Frisium
Malta
Clobazam Atnahs, Clobazam Burk
Netherlands
Clobazam Aurobindo, Clobazam Burk, Clobazam Essential Pharmaceuticals, Clobazam Sandoz, Clobazam Tiofarma, Epaclob, Frisium
Norway
Clobazam Essential Pharmaceuticals
Poland
Frisium
Portugal
Castilium, Clobazam Generis
Slovenia
Klobazam Burk
Spain
Noiafren, Silocalm

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.

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Sources

  1. U.S. Food and Drug Administration. SYMPAZAN (Aquestive Therapeutics) – Prescribing Information, 2025-12-01. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5e3d8fcb-aa7d-4822-88fc-4f06264c3242
  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. 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
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC N05BA.

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.