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# Clobazam (Oral)
## Overview
Clobazam is a benzodiazepine derivative with anticonvulsant properties. It is a 1,5-benzodiazepine, which may confer a different side effect profile compared to 1,4-benzodiazepines.
## Primary Indications
* Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.
* Off-label uses include other seizure types and anxiety disorders, though efficacy and safety for these indications may be less established.
## Adult Dosing
* **Lennox-Gastaut Syndrome (LGS):** The recommended starting dose is 5 mg twice daily. Doses can be increased by 2.5-5 mg every week to a maximum of 10 mg twice daily.
## Pediatric Dosing
* **Lennox-Gastaut Syndrome (LGS, age 2 years and older):** The recommended starting dose is 5 mg twice daily. Doses can be increased by 2.5-5 mg every week to a maximum of 10 mg twice daily.
* **Note:** Dosing in children less than 2 years of age is not well-established.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. No specific dose adjustments are established, but reduced doses may be necessary due to decreased clearance.
* **Renal Impairment:** Use with caution. No specific dose adjustments are established, but reduced doses may be necessary due to potential accumulation.
* **Concomitant Medications:** Clobazam is metabolized by CYP2C19. Caution is advised when used with strong inhibitors or inducers of CYP2C19. Clobazam is also a CYP2C19 substrate and can inhibit CYP2C19.
## Contraindications
* Known hypersensitivity to clobazam or other benzodiazepines.
## Adverse Effects
* **Common:** Drowsiness, somnolence, drooling, constipation, decreased appetite, aggression, irritability, upper respiratory tract infection, pyrexia.
* **Serious:** Suicidal behavior or ideation, severe dermatologic reactions (e.g., Stevens-Johnson syndrome), respiratory depression (especially when combined with other CNS depressants), dependence and withdrawal symptoms, paradoxical reactions.
## Key Drug Interactions
* **CNS Depressants (e.g., opioids, alcohol, other benzodiazepines, sedating antihistamines):** Increased risk of sedation, respiratory depression, coma, and death.
* **CYP2C19 Inhibitors (e.g., fluconazole, omeprazole):** May increase clobazam plasma concentrations, potentially leading to increased adverse effects.
* **CYP2C19 Inducers (e.g., rifampin):** May decrease clobazam plasma concentrations, potentially reducing efficacy.
* **Stimulants (e.g., amphetamines):** May decrease the effectiveness of clobazam.
* **Valproic Acid:** May increase valproic acid levels.
## Monitoring
* Monitor for efficacy (reduction in seizure frequency).
* Monitor for adverse effects, particularly somnolence, behavioral changes, and signs of withdrawal.
* Monitor for signs of suicidal behavior or ideation.
* Consider therapeutic drug monitoring if efficacy or toxicity is a concern, especially with concomitant CYP2C19 altering medications.
## Clinical Pearls
* Clobazam is a Schedule IV controlled substance.
* Withdrawal symptoms can occur upon abrupt discontinuation. Tapering of the dose is recommended.
* The active metabolite, N-desmethylclobazam, has a longer half-life than clobazam and contributes significantly to the overall effect.
* Drowsiness is a common side effect and may be dose-limiting. Patients should be cautioned about activities requiring mental alertness.
* Be aware of potential for increased aggression or behavioral changes, particularly in children.
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**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant clinical guidelines for complete details and to verify information before making clinical decisions.
