What it isZolpidem sublingual tablet (EDLUAR, 2009) — dissolves under the tongue for sleep-onset insomnia; same 5/10 mg doses and pharmacology as oral AMBIEN.
Why this oneSame molecule and receptor pharmacology as the parent card — the formulation (and its label) is the difference.
What limits itClass warnings of the parent molecule apply unchanged.
BOXED WARNING Complex sleep behaviors (sleep-walking, sleep-driving, other activities while not fully awake) may occur and can cause serious injury or death; discontinue immediately if they occur.
FDA dosing
Population
Start
Target
Max
Short-term treatment of insomnia (sleep-initiation difficulty)
Adults
5 mg (women); 5 or 10 mg (men) QHS
5 mg (women) / 5-10 mg (men) QHS
10 mg QD
Renal Undefined
Hepatic 5 mg once daily (do not clear drug as rapidly)
Instructions
Take only once per night immediately before bedtime with ≥7-8 hours remaining before awakening
Place sublingual tablet under the tongue to disintegrate; do not swallow the tablet and do not take with water
Effect may be slowed if taken with or immediately after a meal
Elderly/debilitated patients: 5 mg
Lower doses may be needed with concomitant CNS depressants
Monitor for withdrawal with rapid dose reduction/discontinuation
Available strengths
SL tab 5, 10 mg
cap 7.5 mg
tab 5, 10 mg
ER tab 6.25, 12.5 mg
Contraindications
Patients who have experienced complex sleep behaviors after taking Edluar
Cautions
CNS depressant effects and next-day impairment (incl. impaired driving); risk increases with dose, other CNS depressants, alcohol
Need to evaluate for co-morbid diagnosis if insomnia persists after 7-10 days
Severe anaphylactic/anaphylactoid reactions (angioedema) — do not rechallenge
Respiratory depression in compromised respiratory function; withdrawal effects
Adverse reactions
Drowsiness
Dizziness
Diarrhea
Drugged feeling
Headache
Pregnancy Late third-trimester use may cause neonatal respiratory depression and sedation; no drug-associated birth defect risk identified
Lactation Present in human milk; monitor breastfed infant for excess sedation, hypotonia, respiratory depression
Cost
Zolpidem SL (EDLUAR)
Strength
#/mo
generic $/mo
CostPlus
5 mg
SL tab
30 qd
not offered
10 mg
SL tab
30 qd
not offered
NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Zolpidem SL is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.