Zaleplon
زالپلون
🧠 Nervous SystemNon-benzodiazepine hypnotic (Z-drug)
Market / country: 🇺🇸 USA
Sonata (US)
🧮 Dose calculator
Insomnia · Regimen source: FDA Zaleplon · Dosage and Administration
- • Or after going to bed with difficulty falling asleep. Low weight: 5 mg may suffice. Not above 20 mg. FDA Zaleplon · Dosage and Administration
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Prior complex sleep behaviours with zaleplon; hypersensitivity. FDA Zaleplon · Contraindications
Warnings
- • Boxed warning: complex sleep behaviours (sleep-walking, sleep-driving) sometimes causing serious injury or death — stop immediately if they occur. FDA Zaleplon · Boxed Warning
Formulations
- 10 mg capsule — capsule 🇺🇸 USA FDA Zaleplon · How Supplied
- 5 mg capsule — capsule 🇺🇸 USA FDA Zaleplon · How Supplied
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Zaleplon · Pregnancy
“In embryofetal development studies in rats and rabbits, oral administration of up to 100 mg/kg/day and 50 mg/kg/day, respectively, to pregnant animals throughout organogenesis produced no evidence of teratogenicity.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Zaleplon · Nursing Mothers
“A study in lactating mothers indicated that the clearance and half-life of zaleplon is similar to that in young normal subjects.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Zaleplon · Pediatric Use
“The safety and effectiveness of zaleplon in pediatric patients 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 Zaleplon · Geriatric Use
“In both sleep laboratory and outpatient studies, elderly patients with insomnia responded to a 5 mg dose with a reduced sleep latency, and thus 5 mg is the recommended dose in this population.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA077237
- DailyMed (FDA label)FDA Zaleplon
- MedlinePlus (NIH)Zaleplon
- WHO ATC/DDDN05CF03
- Darooyab (Iran)Zaleplon
🇮🇷 Registered in Iran Darooyab · G-1368/Zaleplon
Dosage forms with Iranian generic codes, per Darooyab.
- 07129 · ZALEPLON 10MG CAP · کپسول زالپلون ۱۰ میلیگرم
- 17947 · ZALEPLON 5MG CAP · کپسول زالپلون ۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Zaleplon · How SuppliedFDA Zaleplon · Dosage and AdministrationFDA Zaleplon · PrecautionsFDA Zaleplon · ContraindicationsFDA Zaleplon · Boxed WarningFDA Zaleplon · SPL approval / marketing categoryFDA Zaleplon · PregnancyFDA Zaleplon · Nursing MothersFDA Zaleplon · Pediatric UseFDA Zaleplon · Geriatric Use
- 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-1368/Zaleplon
- Clinical review⚠ Unverified