Clonazepam Schedule (India)

Schedule H and Schedule X (Psychotropic substance under NDPS Act)

Clonazepam Routes

Oral

Clonazepam Formulations

Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg

Mouth-dissolving tablets (MDT): 0.25 mg, 0.5 mg, 1 mg, 2 mg

Oral drops (solution): 2.5 mg/mL (10 mL bottle)

Injection: NOT AVAILABLE in India (not CDSCO-approved)

Clonazepam Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Epilepsy — Adjunctive or Monotherapy

(Particularly effective for myoclonic seizures, absence seizures, Lennox-Gastaut syndrome, infantile spasms)

Parameter Recommendation

Starting dose 0.5 mg at bedtime OR 0.25 mg twice daily

Titration Increase by 0.25–0.5 mg every 3–5 days based on seizure control and tolerability

Usual maintenance dose 1–4 mg/day in 2–3 divided doses

Maximum dose 20 mg/day (specialist supervision required for doses >6 mg/day)

Clinical Notes:

More effective as adjunctive therapy; tolerance may develop with long-term use

Bedtime dosing preferred initially to minimise daytime sedation

Avoid abrupt discontinuation — risk of withdrawal seizures; taper gradually over 2–4 weeks

May lose efficacy over time (tolerance); reassess periodically

Panic Disorder (With or Without Agoraphobia)

Parameter Recommendation

Starting dose 0.25 mg twice daily OR 0.5 mg at bedtime

Titration Increase by 0.25–0.5 mg every 3 days based on response and tolerability

Usual maintenance dose 1–2 mg/day in 1–2 divided doses

Maximum dose 4 mg/day (specialist prescription for doses >2 mg/day)

Clinical Notes:

Not first-line for panic disorder; SSRIs/SNRIs preferred as initial therapy

Indicated when rapid symptom control needed or SSRIs not tolerated/ineffective

Duration: Short-term preferred (4–12 weeks); plan taper early

Dependence risk increases significantly beyond 4 weeks of continuous use

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Label Status Evidence Basis

Acute catatonia 1–2 mg/day in divided doses; may increase to 4–6 mg/day if needed Short-term; taper after resolution OFF-LABEL; Specialist only Indian psychiatry practice; benzodiazepine-responsive catatonia well-documented

REM sleep behaviour disorder 0.25–0.5 mg at bedtime; may increase to 1 mg Long-term maintenance may be needed OFF-LABEL; Specialist only International RCTs; limited Indian data

Essential tremor (refractory) 0.5–1 mg/day in divided doses Long-term if effective OFF-LABEL; Specialist only Used when propranolol/primidone not tolerated or ineffective

Akathisia (antipsychotic-induced) 0.5–1 mg/day Duration of antipsychotic therapy OFF-LABEL; Specialist only Indian psychiatry practice

Clonazepam Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Epilepsy — Various Seizure Types

(Including myoclonic seizures, absence seizures, Lennox-Gastaut syndrome, infantile spasms)

Age/Weight Starting Dose Titration Usual Maintenance Maximum Dose

Infants 6–12 months 0.01 mg/kg/day in 2–3 divided doses Increase by 0.25 mg every 3–5 days 0.05–0.1 mg/kg/day 0.2 mg/kg/day

Children 1–5 years (10–20 kg) 0.25 mg at bedtime Increase by 0.25 mg every 3–5 days 0.5–1.5 mg/day in 2–3 doses 0.1 mg/kg/day or 3 mg/day

Children 6–12 years (20–40 kg) 0.5 mg at bedtime Increase by 0.25–0.5 mg every 3–5 days 1–3 mg/day in 2–3 doses 0.15 mg/kg/day or 6 mg/day

Adolescents >12 years 0.5–1 mg at bedtime Increase by 0.5 mg every 3–5 days 1.5–4 mg/day in 2–3 doses 0.2 mg/kg/day or 20 mg/day

Clinical Notes:

Oral drops (2.5 mg/mL) preferred for precise weight-based dosing in young children

1 drop ≈ 0.1 mg (verify with specific product)

Bedtime dosing initially to minimise daytime sedation affecting school performance

Increased salivation common in children; monitor for drooling

Safety Monitoring:

Monitor for excessive sedation, behavioural changes, paradoxical agitation

Respiratory monitoring in infants and children with respiratory compromise

Regular assessment of seizure control and developmental milestones

Monitor for signs of dependence with long-term use

Minimum Age: Not recommended in infants <6 months except under paediatric neurologist supervision with appropriate monitoring.

Secondary Indications — Paediatrics (Off-label, if any)

Indication Dose Duration Label Status Evidence Basis

Severe anxiety in neurodevelopmental disorders (autism, intellectual disability) 0.01–0.02 mg/kg/day in divided doses; max 0.05 mg/kg/day Short-term; regular reassessment OFF-LABEL; Specialist only Indian paediatric psychiatry practice; IAP guidelines

Status epilepticus (when IV benzodiazepines unavailable) 0.1 mg/kg buccal/sublingual (crushed tablet or oral drops); max 2 mg Single dose; emergency use OFF-LABEL; Specialist only Limited evidence; emergency use when other options unavailable

Clonazepam Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation

Severe impairment (eGFR <30) Use with caution; start at lower dose; increased sensitivity due to metabolite accumulation

Haemodialysis Not significantly dialysed; no supplemental dose required

Clonazepam Hepatic adjustment

Severity	Recommendation
Mild impairment (Child-Pugh A)	No initial dose adjustment; monitor for sedation
Moderate impairment (Child-Pugh B)	Start at 50% of usual dose; titrate slowly; increased sedation risk
Severe impairment (Child-Pugh C)	Avoid use; significantly prolonged half-life and sedation risk; if essential, use lowest possible dose under specialist supervision

Clonazepam Contraindications

Known hypersensitivity to clonazepam, other benzodiazepines, or any excipient

Acute narrow-angle glaucoma (untreated)

Severe respiratory insufficiency

Severe sleep apnoea syndrome (uncontrolled)

Myasthenia gravis

Severe hepatic impairment (decompensated cirrhosis)

Acute intoxication with alcohol, opioids, or other CNS depressants

Clonazepam Cautions

Chronic respiratory disease (COPD, bronchiectasis) — risk of respiratory depression

History of substance use disorder — high dependence potential

Depression or suicidal ideation — may exacerbate; monitor closely

Elderly patients — increased sensitivity; higher fall risk

Concurrent use with opioids or other CNS depressants — additive respiratory depression

Porphyria — may precipitate acute attack

Cognitive impairment — may worsen confusion

History of paradoxical reactions to benzodiazepines

Long-term use (>4 weeks) — risk of tolerance and dependence; plan taper strategy early

Abrupt discontinuation — risk of rebound seizures and withdrawal symptoms

Clonazepam Pregnancy

Parameter Recommendation

Risk category High risk (Category D equivalent); known teratogenic potential

Known risks First trimester: increased risk of oral clefts; Third trimester: neonatal hypotonia, respiratory depression, withdrawal ("floppy infant syndrome")

Preferred alternatives For epilepsy: Levetiracetam, Lamotrigine (with folic acid supplementation); For anxiety: Non-pharmacological; SSRIs if medication essential

When it may be used Only if benefit clearly outweighs risk; uncontrolled seizures pose significant risk to mother and fetus

Monitoring Fetal anomaly scan; fetal growth monitoring; neonatal observation for hypotonia, respiratory depression, withdrawal symptoms (feeding difficulties, irritability, tremors)

Clonazepam Lactation

Parameter Recommendation

Compatibility Use with caution; not absolutely contraindicated

Drug levels in milk Low to moderate; infant exposure estimated at 2–5% of maternal weight-adjusted dose

Preferred alternatives For epilepsy: Levetiracetam, Carbamazepine; For anxiety: SSRIs (sertraline preferred)

Infant monitoring Monitor for sedation, poor feeding, hypotonia, poor weight gain

Recommendations If essential, use lowest effective dose; monotherapy preferred; avoid breastfeeding at time of peak maternal plasma levels (2–4 hours post-dose)

Clonazepam Elderly

Starting dose: 0.25 mg once daily (usually at bedtime); some may require 0.125 mg

Titration: Very slow; increase no more than 0.25 mg every 5–7 days

Usual maintenance dose: 0.5–1 mg/day; rarely exceed 2 mg/day

Extra risks:

Increased sensitivity to CNS effects

Higher risk of falls and hip fractures

Paradoxical agitation and confusion more common

Daytime sedation and cognitive impairment

Impaired driving and operating machinery

Association with increased dementia risk with long-term use

Recommendations:

Avoid long-term use for anxiety or insomnia

Review need regularly; plan for discontinuation

Consider non-benzodiazepine alternatives where possible

Clonazepam Major drug interactions

Interacting Drug/Class Mechanism/Effect Recommendation

Opioids (morphine, tramadol, codeine, fentanyl) Additive CNS and respiratory depression; risk of fatal overdose Avoid combination if possible; if essential, reduce doses of both and monitor closely

Alcohol Synergistic CNS depression Avoid concomitant use; counsel patients

Clozapine Increased risk of cardiovascular collapse, respiratory depression Avoid initiation of clonazepam in patients on clozapine; if essential, start at very low dose with close monitoring

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) Increased clonazepam levels; prolonged sedation Reduce clonazepam dose; monitor for toxicity

CYP3A4 inducers (carbamazepine, phenytoin, phenobarbital, rifampicin) Decreased clonazepam levels; reduced efficacy May need to increase clonazepam dose; monitor seizure control

Clonazepam Moderate drug interactions

Interacting Drug/Class Mechanism/Effect Recommendation

Valproate Additive CNS depression; may increase clonazepam levels Monitor for excessive sedation; may need dose reduction

SSRIs (fluoxetine, fluvoxamine) CYP inhibition; may increase clonazepam levels Monitor for sedation; consider dose adjustment

Other antiepileptics (lamotrigine, levetiracetam) Additive CNS effects Generally used together; monitor for sedation

Antipsychotics Additive sedation and hypotension Monitor blood pressure and sedation

Sedating antihistamines Additive CNS depression Avoid combination or use with caution

Theophylline May reduce benzodiazepine effect (antagonism) Monitor clinical response

Antihypertensives Additive hypotensive effect Monitor blood pressure

Clonazepam Common Adverse effects

Drowsiness and fatigue (most common; up to 50%)

Dizziness and unsteadiness

Impaired coordination and ataxia

Cognitive impairment (memory, concentration difficulties)

Increased salivation and drooling (especially in children)

Depression or emotional blunting

Muscle weakness

Slurred speech

Clonazepam Serious Adverse effects

Respiratory depression (especially with co-sedatives or in respiratory disease) — may require ventilatory support

Paradoxical reactions (aggression, agitation, hostility, psychosis) — discontinue if occurs

Severe allergic reactions including Stevens-Johnson syndrome (rare)

Physical dependence and withdrawal syndrome (seizures, psychosis, tremors) — taper gradually

Suicidal ideation or worsening depression — monitor and reassess

Neonatal complications if used late in pregnancy (hypotonia, respiratory depression, withdrawal)

Anterograde amnesia

Clonazepam Monitoring requirements

Timing	Parameters
Baseline	Hepatic function; psychiatric history (depression, suicidality, substance use); respiratory function if concerns; seizure frequency and type

After initiation/dose change Monitor for excessive sedation, ataxia, behavioural changes; seizure frequency; paradoxical reactions (within first 2 weeks)

Long-term Periodic assessment of continued need; signs of tolerance or dependence; cognitive function; seizure control; psychiatric status; liver function annually if high doses

Pregnancy Fetal anomaly scan; growth monitoring; neonatal observation post-delivery

Clonazepam Brands in India

Rivotril® (Sun Pharma/Roche)

Clonotril® (Torrent)

Lonazep® (Intas)

Epitril® (Sanofi)

Clozep® (Cipla)

Zapiz® (USV)

Clonafit® (Mankind)

Petril® (Micro Labs)

Clonax® (Win Medicare)

Multiple generic formulations from various manufacturers

Clonazepam Price range (INR)

Formulation	Approximate Price (per tablet)
Tablets 0.25 mg	₹0.80–2.50 per tablet
Tablets 0.5 mg	₹1–3 per tablet NLEM-listed; NPPA price-controlled
Tablets 1 mg	₹2–5 per tablet
Tablets 2 mg	₹3–7 per tablet
MDT (various strengths)	₹1.50–5 per tablet Slight premium over regular tablets
Oral drops 2.5 mg/mL (10 mL)	₹35–70 per bottle

NLEM Status: Clonazepam 0.5 mg tablet is included in NLEM 2022; NPPA price-controlled.

Government Supply: Available through government hospitals and Jan Aushadhi stores.

Clonazepam Clinical pearls

Never discontinue abruptly — taper gradually over 2–4 weeks (reduce by 0.125–0.25 mg every 3–5 days) to prevent withdrawal seizures, especially in epilepsy patients

Not first-line for generalised anxiety disorder or insomnia — SSRIs/SNRIs and non-benzodiazepine hypnotics preferred; clonazepam reserved for panic disorder or specific seizure types

Tolerance to antiseizure effect may develop over months; periodic reassessment of efficacy needed; may require dose increase or switching to alternative agent

In children, oral drops allow precise weight-based dosing and easier administration; calculate dose carefully (2.5 mg/mL = 0.1 mg per drop approximately)

Warn patients about impaired driving and operating machinery; effects may persist into following day due to long half-life (18–50 hours)

High potential for misuse and diversion — prescribe minimum necessary quantity; regular review of prescription pattern required under Schedule X regulations

Clonazepam Tags

clonazepam; benzodiazepine; epilepsy; myoclonic seizures; panic disorder; Schedule X; CNS depressant; dependence-risk; paediatric-neurologist; pregnancy-Category-D; NLEM India

Clonazepam Version

RxIndia v1.0 — 29 May 2025

Clonazepam Reference

CDSCO product database

Indian Pharmacopoeia / National Formulary of India

NLEM 2022

API Textbook of Medicine

AIIMS Neurology and Psychiatry Protocols

ICMR Guidelines for Epilepsy Management

IAP Guidelines for Paediatric Neurology

Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive pharmacologic reference)

RCT evidence for REM sleep behaviour disorder and essential tremor (off-label indications only)

RxIndia

The Drug Registry

Clonazepam

Diazepam