Clobazam
ONFI
Pronunciation: KLOE-ba-zam (ON-fee)
“Clobber On wi-fi”
pronounced “ON-fee”
hot pink → benzo theme
What it is1,5-benzodiazepine; Lennox-Gastaut, Dravet syndrome and adjunctive focal seizures.
Why this oneLess sedation than the 1,4-benzodiazepines at anticonvulsant doses.
What limits itTolerance to the anticonvulsant effect develops in many. CYP2C19 makes exposure vary severalfold; dependence as for the class.
FDA-approved for
- Lennox-Gastaut syndrome (2011)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Adjunctive treatment of seizures in Lennox-Gastaut syndrome | ≤30 kg body weight | 5 mg/day | 20 mg/day (BID; ≤5 mg may be QD) | 20 mg/day |
| Adjunctive treatment of seizures in Lennox-Gastaut syndrome | >30 kg body weight | 10 mg/day | 40 mg/day (BID) | 40 mg/day |
Titration Do not escalate more rapidly than weekly (steady state of clobazam/active metabolite takes 5-9 days).
Renal No adjustment needed for mild-to-moderate renal impairment (severe impairment/ESRD not studied)
Hepatic Mild-to-moderate (Child-Pugh 5-9): start 5 mg/day, titrate to half the usual weight-based dose; severe impairment not established
Instructions
- Doses above 5 mg/day given in two divided doses
- Tablets: give whole, broken along the score, or crushed and mixed in applesauce; with or without food
- Taper to discontinue: decrease total daily dose by 5-10 mg/day on a weekly basis
- Geriatric patients and CYP2C19 poor metabolizers: start 5 mg/day and titrate to half the usual dose
Available strengths
- tab 5, 10, 20 mg
- susp 2.5 mg/mL
- film 5, 10, 20 mg
Cautions
- Somnolence and sedation; potentiated by other CNS depressants and alcohol
- Serious dermatological reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- DRESS/multiorgan hypersensitivity
- Suicidal behavior and ideation
- Neonatal sedation and withdrawal syndrome with late-pregnancy use
- Physical dependence and withdrawal (including seizures/status epilepticus with abrupt discontinuation)
- Abuse, misuse, and addiction
Adverse reactions
- Constipation
- Somnolence/sedation
- Pyrexia
- Lethargy
- Drooling
- Ataxia
- Aggression
- Upper respiratory tract infection
Pregnancy Late-pregnancy use can cause neonatal sedation and/or withdrawal; animal studies show developmental toxicity (fetal malformations, mortality) below therapeutic exposures.
Lactation Excreted in human milk; reports of sedation, poor feeding, and poor weight gain in exposed infants — monitor.
Cost
| Strength | #/mo | generic $ | CostPlus | |
|---|---|---|---|---|
| 5 mg | tab | 60 BID | not offered | |
| 10 mg | tab | 60 BID | $14.56/mo | not offered |
| 20 mg | tab | 60 BID | $25.92/mo | not offered |
| 2.5 mg/mL | susp | per unit | $0.17/mL | not offered |
Generic entry2018
⚠ BOXED WARNINGS
- Risk from concomitant use with opioids
- Abuse, misuse and addiction
- Dependence and withdrawal reactions
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilitySedation, dependence and respiratory depression, especially with opioids or other depressants.
Active metabolites
Open Clobazam in the interactive console ↗
Memory aids: interaction avatars
