Sleep-wake disorders:

Indications for EDLUAR:

Short-term treatment of insomnia (w. difficulties in sleep initiation).

Adult:

Use lowest effective dose. Effects delayed if taken with or after a meal. Place 1 tab under the tongue and allow to dissolve; do not take with water. Take once per night immediately before bedtime (with at least 7–8hrs remaining before planned time of awakening). Women: initially 5mg. Men: initially 5mg or 10mg. Both: if 5mg ineffective, may increase to max 10mg. Elderly, debilitated, or hepatic impairment: 5mg.

Children:

<18yrs: not recommended.

Contraindications:

Prior history of complex sleep behaviors with Edluar.

Boxed Warning:

Complex sleep behaviors.

Warnings/Precautions:

Risk of complex sleep behaviors (eg, sleep-walking, sleep-driving, engaging in other activities while not fully awake); discontinue immediately if occur. Monitor for CNS depressant effects and next-day impairment. Evaluate for co-morbid diagnoses (eg, physical and/or psychiatric disorders) prior to treatment. Reevaluate if insomnia fails to remit after 7–10 days of use. Depression. Suicidal tendencies. Evaluate any new onset of behavioral changes. Compromised respiratory function. Sleep apnea. Myasthenia gravis. Drug or alcohol abuse. Hepatic impairment. Avoid abrupt cessation. Write ℞ for smallest practical amount. Elderly (higher risk of falls). Debilitated. Pregnancy: monitor neonates. Nursing mothers: monitor infants (consider interrupting breastfeeding or pumping/discarding breast milk during and for 23hrs after administration).

Pharmacologic Class:

Imidazopyridine hypnotic.

Interactions:

Concomitant other sedative-hypnotics including other zolpidem products: not recommended. Potentiates CNS depression with alcohol, other CNS depressants (eg, benzodiazepines, opioids, tricyclics); adjust dose. May be potentiated by CYP3A4 inhibitors (eg, ketoconazole; consider lower zolpidem dose), sertraline. May be antagonized by CYP3A4 inducers (eg, rifampin). Decreased alertness with imipramine, chlorpromazine.

Adverse Reactions:

Drowsiness, dizziness, diarrhea, drugged feelings (long-term); abnormal thinking and behavioral changes; rare: anaphylaxis, angioedema (do not rechallenge).

Generic Availability:

NO

How Supplied:

SL tabs—30

Pricing for EDLUAR

10mg sublingual (Qty: 30)
Appx. price $391
GoodRx