Schedule H

Oral, Intravenous, Intramuscular, Rectal

Form Available Strengths

Tablet 2 mg, 5 mg, 10 mg

Injection 5 mg/mL (2 mL and 10 mL ampoules)

Rectal Gel 5 mg/mL, 10 mg/mL (prefilled applicators)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Anxiety Disorders (Short-Term Management)

Parameter Recommendation

Starting dose 2–5 mg orally once or twice daily

Titration Increase by 2 mg increments every 3–5 days based on response and tolerability

Usual maintenance dose 5–10 mg/day in 2–3 divided doses

Maximum dose 30 mg/day

Clinical Notes:

• Restrict use to ≤4 weeks to minimize dependence risk

• Taper gradually if used beyond 2 weeks

• Not appropriate for long-term anxiety management

1. Status Epilepticus (Acute Management)

Parameter Recommendation

Starting dose 5–10 mg IV administered at rate ≤2 mg/minute

Titration May repeat single dose after 10–15 minutes if seizure persists

Usual maintenance dose Not applicable (acute use only)

Maximum dose 30 mg per episode

Clinical Notes:

• IV route preferred; IM absorption is erratic

• Resuscitation equipment must be immediately available

• Must be followed by long-acting antiepileptic agent (phenytoin, levetiracetam)

1. Acute Muscle Spasms

Parameter Recommendation

Starting dose 2–5 mg orally twice or thrice daily

Titration Adjust every 2–3 days based on symptom control

Usual maintenance dose 5–15 mg/day in divided doses

Maximum dose 15 mg/day

Clinical Notes:

• Use for short duration only (1–2 weeks)

• Peak muscle relaxant effect typically achieved within first few days

1. Alcohol Withdrawal Syndrome

Phase Dosing Approach

Starting dose (Day 1) 10 mg orally every 6–8 hours

Titration Reduce total daily dose by 20–25% each day

Usual maintenance dose Taper over 5–7 days to zero

Maximum dose 40 mg/day (Day 1 only)

Clinical Notes:

• Symptom-triggered dosing protocol preferred in supervised settings

• Gradual taper essential to prevent rebound seizures

• Monitor CIWA-Ar score where applicable

1. Premedication Before Procedures (Sedation/Anxiolysis)

Route Dosing

Oral 5–10 mg given 45–60 minutes before procedure

Intravenous 5–10 mg given slowly 20–30 minutes before procedure

Titration Not applicable (single-dose use)

Maximum dose 10 mg per occasion

Clinical Notes:

• Reduce dose by 50% in elderly and debilitated patients

• Continuous monitoring required with IV administration

• Avoid concomitant opioid premedication without airway support

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

Indication Dose Duration Notes

Night terrors / Sleepwalking 2–5 mg orally at bedtime 1–2 weeks maximum OFF-LABEL • Specialist only • Evidence: Limited case series and Indian specialist practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Febrile Seizures — Emergency Use

Parameter Recommendation

Starting dose Rectal: 0.3–0.5 mg/kg as single dose

Titration May repeat once after 10–15 minutes if seizure continues

Usual maintenance dose Not applicable (acute use only)

Maximum dose 10 mg per dose

Safety Monitoring:

• Monitor respiratory rate and oxygen saturation for minimum 60 minutes post-administration

• Minimum age: 6 months

1. Status Epilepticus

Route Dosing

Intravenous 0.2–0.3 mg/kg administered slowly over 2–3 minutes

Intramuscular 0.2–0.3 mg/kg (only if IV access unavailable)

Rectal 0.5 mg/kg

Maximum single dose 10 mg

Repeat dosing May repeat once after 10–15 minutes

Safety Monitoring:

• Resuscitation facilities mandatory

• Continuous pulse oximetry during and after administration

• Neonatal use: Only under specialist supervision when absolutely necessary

1. Procedural Sedation

Route Dosing Timing

Oral 0.2–0.5 mg/kg 30–60 minutes before procedure

Intravenous 0.1–0.2 mg/kg given slowly Immediately before procedure

Maximum dose 10 mg regardless of route

Safety Monitoring:

• Continuous cardiorespiratory monitoring mandatory

• Only in settings with resuscitation capability

• Recovery monitoring for minimum 2 hours

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

Indication Recommendation

Infantile spasms NOT RECOMMENDED — Other agents preferred (vigabatrin, ACTH)

Age Restriction Statement:

Not recommended below 6 months of age except under specialist supervision due to immature hepatic metabolism, increased CNS sensitivity, and higher risk of respiratory depression.

Severe impairment (eGFR <30) Use with caution; increased CNS sensitivity may occur

Haemodialysis Not significantly dialysable; no supplemental dosing required

Peritoneal dialysis No dose adjustment; monitor for sedation

• Acute narrow-angle glaucoma

• Myasthenia gravis

• Severe respiratory insufficiency

• Obstructive sleep apnoea syndrome (untreated)

• Known hypersensitivity to diazepam or other benzodiazepines

• Severe hepatic impairment with encephalopathy

• Acute alcohol intoxication with depressed vital signs

• History of substance use disorder or dependence

• Elderly or debilitated patients (increased fall risk, excessive sedation)

• Depression with suicidal ideation

• Chronic obstructive pulmonary disease

• Concomitant use of other CNS depressants

• Prolonged use (>4 weeks) — risk of physical dependence

• Avoid abrupt discontinuation after prolonged therapy — risk of withdrawal seizures

• Organic brain syndrome

Parameter Recommendation

Risk category Category D — Evidence of fetal risk; crosses placenta freely

Known risks First trimester: possible increased risk of cleft palate; Third trimester: neonatal floppy infant syndrome, withdrawal symptoms

When to use Only when benefit clearly outweighs risk; after specialist consultation

Preferred alternatives Lorazepam may be preferred for acute seizures if benzodiazepine essential

Monitoring Neonatal respiratory status, muscle tone, feeding ability, withdrawal signs

Parameter Recommendation

Compatibility Not recommended; excreted in breast milk in significant amounts

Expected milk levels Moderate; active metabolite (desmethyldiazepam) has prolonged half-life

Preferred alternatives Lorazepam or oxazepam (shorter-acting, no active metabolites)

If used Short course only (<5 days); observe infant for sedation, poor feeding, weight loss

Infant monitoring Sedation, feeding difficulty, inadequate weight gain

Parameter Recommendation

Recommended starting dose 1–2 mg orally once or twice daily

Titration Slow; increase by 1 mg increments at intervals of ≥5 days

Maximum dose 10 mg/day (lower than adults)

Extra risks Falls, hip fractures, confusion, paradoxical agitation, delirium, oversedation

Preferred alternatives Shorter-acting benzodiazepines (lorazepam, oxazepam) where feasible

Interacting Drug Effect Recommendation

Opioids (morphine, tramadol, fentanyl) Profound sedation, respiratory depression, death Avoid combination; if unavoidable, reduce doses of both and monitor closely

Clozapine Severe sedation, respiratory collapse, cardiovascular instability Combination contraindicated

Alcohol Synergistic CNS and respiratory depression Advise complete avoidance

Barbiturates Additive respiratory depression Avoid combination

Sodium oxybate Enhanced CNS depression Contraindicated combination

Interacting Drug Effect Recommendation

Valproate Displacement from protein binding; increased free diazepam levels Monitor for enhanced sedation

Carbamazepine, Phenytoin CYP induction; reduced diazepam efficacy May need higher diazepam doses

Rifampicin Strong CYP induction; significantly reduced diazepam effect Alternative benzodiazepine or dose increase may be needed

Ketoconazole, Itraconazole CYP3A4 inhibition; increased diazepam levels Reduce diazepam dose; monitor sedation

Cimetidine, Omeprazole Inhibits diazepam metabolism Monitor for excess sedation

Sedating antihistamines Additive CNS depression Use cautiously; warn patient

Antihypertensives Additive hypotensive effect Monitor blood pressure

Combined oral contraceptives Minor inhibition of diazepam metabolism Usually no adjustment needed; monitor if symptoms arise

• Drowsiness

• Fatigue and lethargy

• Muscle weakness

• Ataxia and impaired coordination

• Blurred vision

• Dizziness

• Slurred speech (dose-related)

• Anterograde amnesia

Adverse Effect Notes

Respiratory depression Especially with IV use or CNS depressant combinations; may require ventilatory support

Hypotension More common with rapid IV administration

Paradoxical reactions Excitement, aggression, hallucinations — more common in elderly and children

Physical dependence With prolonged use (>4 weeks)

Withdrawal seizures If discontinued abruptly after chronic use

Cognitive impairment Long-term use associated with memory deficits

Suicidal ideation May unmask depression; monitor closely

Phase Parameters

Baseline Hepatic function (if prolonged use anticipated), mental status assessment, respiratory status (for IV/IM use)

After initiation/dose change Level of sedation, respiratory rate, blood pressure (especially elderly, paediatric, IV route)

Long-term use Signs of dependence, cognitive function, mood changes, falls assessment in elderly

• Calmpose™ (Sun Pharma)

• Valium™ (Abbott)

• Dizep™ (Cipla)

• Zepose™ (various)

• Diazepam Injection IP (multiple generics)

• Rektol® (Rectal gel)

Note: Included in NLEM 2022; available at subsidized rates through Jan Aushadhi outlets. Price controlled under DPCO.

• Duration limit: Restrict use to <4 weeks for anxiety; long-term use causes tolerance and dependence

• Status epilepticus: First-line agent for initial seizure control, but always follow with a long-acting antiepileptic (phenytoin, levetiracetam)

• Rectal route: Remains first-choice for pre-hospital seizure management in children; teach caregivers proper technique

• Elderly prescribing: "Start low, go slow" — begin with 1–2 mg; prefer shorter-acting alternatives when possible

• Dangerous combinations: Concomitant opioids or alcohol dramatically increase respiratory depression risk

• Discontinuation: Never stop abruptly after >2 weeks of regular use — taper by 10–25% weekly to prevent withdrawal seizures

diazepam; benzodiazepine; anxiety; status epilepticus; seizures; muscle relaxant; alcohol withdrawal; rectal diazepam; pregnancy-risk; elderly-caution; Schedule-H; NLEM India

RxIndia v1.1 — 25 May 2025

• CDSCO (Product Information)

• Indian Pharmacopoeia

• NLEM 2022

• API Textbook of Medicine

• AIIMS Drug Formulary

• IAP Guidelines (Paediatric Dosing)

• WHO Model Formulary (supportive reference)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (pharmacology basis)