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Edluar Generic Name & Formulations
Legal Class
CIV
General Description
Zolpidem tartrate 5mg, 10mg; sublingual tabs.
Pharmacological Class
Imidazopyridine hypnotic.
How Supplied
SL tabs—30
Manufacturer
Generic Availability
NO
Edluar Indications
Indications
Short-term treatment of insomnia (w. difficulties in sleep initiation).
Edluar Dosage and Administration
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.
Edluar Contraindications
Contraindications
Prior history of complex sleep behaviors with Edluar.
Edluar Boxed Warnings
Boxed Warning
Complex sleep behaviors.
Edluar Warnings/Precautions
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).
Edluar Pharmacokinetics
See Literature
Edluar Interactions
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.
Edluar Adverse Reactions
Adverse Reactions
Drowsiness, dizziness, diarrhea, drugged feelings (long-term); abnormal thinking and behavioral changes; rare: anaphylaxis, angioedema (do not rechallenge).
Edluar Clinical Trials
See Literature
Edluar Note
Not Applicable
Edluar Patient Counseling
See Literature
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