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Sodium oxybate

سدیم اکسی‌بات

⚠ Unverified

🧠 Nervous SystemCNS depressant (GHB)

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA021196 ATC N07XX04

Market / country: 🇺🇸 USA

Xyrem (US)

🧮 Dose calculator

Disease / regimen

Narcolepsy and excessive daytime sleepiness · Regimen source: FDA Xyrem · 2.1 FDA Xyrem · 2.2 FDA Xyrem · 2.5

⛔ At night in two doses: half at bedtime, half 2.5–4 h later. Increase by 1.5 g/night weekly to 6–9 g. Children ≥7 y: per label weight table. Starting divalproex: reduce by 20%. FDA Xyrem · 2.1 FDA Xyrem · 2.2 FDA Xyrem · 2.5

🛡️ Safety & information

Contraindications

⛔ With sedative hypnotics or alcohol; succinic semialdehyde dehydrogenase deficiency. FDA Xyrem · 4

Warnings

• Boxed warning: CNS and respiratory depression; abuse and misuse (GHB); available only through REMS. FDA Xyrem · Boxed Warning

Formulations

0.5 g/mL oral solution — solution 🇺🇸 USA FDA Xyrem · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Xyrem · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Xyrem · 8.2
“Risk Summary GHB is excreted in human milk after oral administration of sodium oxybate.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Xyrem · 8.4
“The safety and effectiveness of Xyrem in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients (7 years of age and older) with narcolepsy have been established in a double-blind, placebo-controlled, randomized-withdrawal study [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.3 )] .”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Xyrem · 8.5
“In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)NDA021196
DailyMed (FDA label)FDA Xyrem
MedlinePlus (NIH)❌ None
WHO ATC/DDDN07XX04
Darooyab (Iran)Sodium-Oxybate

🇮🇷 Not found in Iran list Darooyab · G-2678/Sodium-Oxybate

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)✅ Present
FDA Xyrem · 3 FDA Xyrem · 2.1 FDA Xyrem · 2.2 FDA Xyrem · 2.5 FDA Xyrem · 4 FDA Xyrem · Boxed Warning FDA Xyrem · SPL approval / marketing category FDA Xyrem · 8.1 FDA Xyrem · 8.2 FDA Xyrem · 8.4 FDA Xyrem · 8.5
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)✅ Present
Darooyab · G-2678/Sodium-Oxybate
Clinical review⚠ Unverified

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