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
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