Zolfresh (Zolpidem Tartrate)
Also sold as: Zolfresh, Nitrest, Ambien, Stilnoct, Zoldem
Pregnancy
Cat C
Lactation
Caution
Schedule
X
Forms
Tablet 5mg, 10mg (immediate release) +1
Indications
- Short-term treatment of insomnia (difficulty initiating sleep)
- Sleep maintenance (CR formulation)
Adult Dosing
Insomnia (sleep onset)
10 mg PO immediately before bedtime
Elderly/debilitated/hepatic impairment: start 5 mg. Women: lower doses recommended (5 mg) due to slower elimination — next-day impairment higher than men at 10 mg. Take only when you can have 7–8 full hours in bed.
Pediatric Dosing
Controlled trial failed to show efficacy in children; adverse neuropsychiatric effects noted
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| Any CrCl | No dose adjustment — hepatically metabolised. Use with caution in severe renal impairment. |
Hepatic Adjustment
Severe hepatic impairment: avoid or use 5 mg (impaired metabolism, prolonged sedation)
Pregnancy & Lactation
Pregnancy: Category C
Avoid in pregnancy if possible — neonatal withdrawal syndrome, floppy infant syndrome, neonatal respiratory depression reported. If used near delivery, monitor neonate closely.
Lactation: Caution
Excreted in breast milk — avoid. Infant sedation risk. If used, avoid breastfeeding for several hours after dose.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| CNS depressants (opioids, benzodiazepines, alcohol, antihistamines, antipsychotics) | Additive CNS/respiratory depression — potentially fatal. Opioid + zolpidem: FDA black box warning in USA. | Major |
| CYP3A4 inhibitors (ketoconazole, fluconazole, ritonavir) | Increase zolpidem levels — prolonged sedation | Major |
| CYP3A4 inducers (rifampicin, carbamazepine) | Reduce zolpidem levels — reduced efficacy | Moderate |
| SSRIs (fluoxetine, sertraline) | May increase zolpidem levels; pharmacodynamic interaction — additive CNS effects | Moderate |
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Side Effects
Common
- Drowsiness (next-day residual — especially at 10 mg in women and elderly)
- Dizziness
- Headache
- Nausea
- Anterograde amnesia (cannot form memories while drug is active)
- Somnambulism (sleepwalking — rare but serious)
- Dependency (with regular use > 4 weeks)
Serious / Discontinue If
- Complex sleep behaviours: sleep-driving, sleep-eating, sleep-sex (without recollection — FDA black box 2019)
- Paradoxical reactions (agitation, aggression, hallucinations — especially with alcohol)
- Next-day driving impairment (especially women — 5 mg recommended in women)
- Physical and psychological dependence (Schedule X in India)
- Withdrawal on abrupt stopping (anxiety, rebound insomnia, seizures — rare)
Contraindications
- Severe hepatic impairment
- Sleep apnoea
- Myasthenia gravis
- Acute pulmonary insufficiency
- History of drug dependence (relative)
- Concomitant alcohol use
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Zolfresh 10mg | Sun Pharma | 10 tab ₹145 (Schedule X — prescription mandatory) |
| Nitrest 10mg | Cipla | 10 tab ₹138 |
| Zoldem 10mg | Mankind | 10 tab ₹125 |
Monitoring Required
- Sleep diary (latency, maintenance, quality)
- Next-day alertness/psychomotor function
- Dependency assessment (if used > 4 weeks)
- Withdrawal symptoms if stopping after prolonged use
- Driving ability assessment
Patient Counseling Points
- ⚠️ Schedule X — requires prescription and cannot be purchased OTC; controlled drug with dependency risk
- Take immediately before getting into bed — it works within 15–30 minutes; do not take and then do other activities
- Ensure you can sleep for 7–8 full hours after taking — next-day driving impairment is a real risk
- ⚠️ NEVER drink alcohol when taking zolpidem — dangerous interaction
- Do not take for more than 4 weeks without medical review — dependency develops rapidly
- Sleepwalking or other activities without remembering: stop zolpidem immediately and contact your doctor
- Women: 5 mg is safer than 10 mg — discuss with your doctor
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Clinically reviewed by: Dr. Vikas Desai, MD (Psychiatry), Senior Consultant Psychiatrist
Last reviewed: 2026-04-01
References
- FDA Zolpidem Safety Communication 2019 (complex sleep behaviours)
- ICMR Guidelines on Insomnia Management
- BNF — Zolpidem
- AASM Sleep Disorders Classification and Management