Zolpidem
زولپیدم
🧠 Nervous SystemNon-benzodiazepine hypnotic
Market / country: 🇺🇸 USA
Ambien (US)
🧮 Dose calculator
Insomnia · Regimen source: FDA Zolpidem · 2.1
- • Once per night with 7–8 h before waking. If 5 mg ineffective, 10 mg. Shortest possible course. FDA Zolpidem · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Prior complex sleep behaviours with zolpidem; hypersensitivity. FDA Zolpidem · 4
- ⛔ Not recommended in children. FDA Zolpidem · 8.4
- ⚠️ Boxed warning: complex sleep behaviours (sleep-walking, sleep-driving) with serious injury or death. FDA Zolpidem · Boxed Warning
Formulations
- 5 mg tablet — tablet 🇺🇸 USA FDA Zolpidem · 3
- 10 mg tablet — tablet 🇺🇸 USA FDA Zolpidem · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Zolpidem · 8.1
“Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data ] .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Zolpidem · 8.2
“Risk Summary Limited data from published literature report the presence of zolpidem in human milk.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Zolpidem · 8.4
“Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Zolpidem · 8.5
“… to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see Warnings and Precautions ( 5.2 ) ].”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA077903
- DailyMed (FDA label)FDA Zolpidem
- MedlinePlus (NIH)Zolpidem
- WHO ATC/DDDN05CF02
- Darooyab (Iran)Zolpidem
🇮🇷 Registered in Iran Darooyab · G-1371/Zolpidem
Dosage forms with Iranian generic codes, per Darooyab.
- 06028 · ZOLPIDEM 10MG TAB · قرص زولپیدم ۱۰ میلیگرم
- 07253 · ZOLPIDEM 5MG TAB · قرص زولپیدم ۵ میلیگرم
- 53130 · ZOLPIDEM E.R 6.25 mg TABLET · قرص آهستهرهش زولپیدم ۶٫۲۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Zolpidem · 3FDA Zolpidem · 2.1FDA Zolpidem · 4FDA Zolpidem · 8.4FDA Zolpidem · Boxed WarningFDA Zolpidem · 8.1FDA Zolpidem · 8.2FDA Zolpidem · 8.5FDA Zolpidem · 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-1371/Zolpidem
- Clinical review⚠ Unverified