Eszopiclone
اسزوپیکلون
🧠 Nervous SystemNon-benzodiazepine hypnotic (Z-drug)
Market / country: 🇺🇸 USA
Lunesta (US)
🧮 Dose calculator
Insomnia · Regimen source: FDA Lunesta · 2.1
- • At least 7–8 h before planned awakening. Elderly/debilitated, severe hepatic impairment or strong CYP3A4 inhibitors: max 2 mg. Not with or right after a heavy meal. FDA Lunesta · 2FDA Lunesta · 2.2FDA Lunesta · 2.3FDA Lunesta · 2.5
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Prior complex sleep behaviours with eszopiclone; hypersensitivity (anaphylaxis, angioedema). FDA Lunesta · 4
Warnings
- • Boxed warning: complex sleep behaviours (sleep-walking, sleep-driving) sometimes causing serious injury or death — stop immediately if they occur. FDA Lunesta · Boxed Warning
- • CNS depression and next-day driving impairment (especially 2 or 3 mg); abnormal behaviour; withdrawal effects. FDA Lunesta · 5
Formulations
- 1 mg tablet — tablet 🇺🇸 USA FDA Lunesta · 3
- 2 mg tablet — tablet 🇺🇸 USA FDA Lunesta · 3
- 3 mg tablet — tablet 🇺🇸 USA FDA Lunesta · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Lunesta · 8.1
“Risk Summary Available pharmacovigilance data with LUNESTA use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Lunesta · 8.2
“Risk Summary There are no data on the presence of eszopiclone in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Lunesta · 8.4
“Safety and effectiveness of LUNESTA have not been established in pediatric patients.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Lunesta · 8.5
“LUNESTA 2 mg exhibited significant reduction in sleep latency and improvement in sleep maintenance in the elderly population.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA021476
- DailyMed (FDA label)FDA Lunesta
- MedlinePlus (NIH)Eszopiclone
- WHO ATC/DDDN05CF04
- Darooyab (Iran)Eszopiclone
🇮🇷 Not found in Iran list Darooyab · G-4905/Eszopiclone
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Lunesta · 3FDA Lunesta · 2.1FDA Lunesta · 2FDA Lunesta · 2.2FDA Lunesta · 2.3FDA Lunesta · 2.5FDA Lunesta · 4FDA Lunesta · Boxed WarningFDA Lunesta · 5FDA Lunesta · 8.1FDA Lunesta · 8.2FDA Lunesta · 8.4FDA Lunesta · 8.5FDA Lunesta · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-4905/Eszopiclone
- Clinical review⚠ Unverified