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EDLUAR
Sleep-wake disorders
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Drug Name:

EDLUAR CIV

Generic Name and Formulations:
Zolpidem tartrate 5mg, 10mg; sublingual tabs.

Company:
Meda Pharmaceuticals

Therapeutic Use:

Indications for EDLUAR:

Insomnia.

Adult:

≥18yrs: Use lowest effective dose. Place 1 tab under tongue and allow to dissolve; do not take with food, water, or alcohol. Initially 5mg (in women), and 5mg or 10mg (in men) at bedtime (take only if able to get 7–8hrs of sleep before becoming active again). Both: if 5mg dose ineffective, may increase to max 10mg. Elderly, debilitated, or hepatic impairment: 5mg once daily at bedtime. Effect delayed if taken with a meal.

Children:

<18yrs: not recommended.

Warnings/Precautions:

Increased risk of next-day psychomotor impairment. Depression. Abnormal thinking and behavioral changes. Compromised respiratory function (eg, sleep apnea). Conditions that affect metabolism or hemodynamic response. Myasthenia gravis. Evaluate for co-morbid diagnoses before initiation. Reevaluate if insomnia persists after 7–10 days of use. Drug or alcohol abuse. Write Rx for smallest practical amount. Withdraw gradually. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.

Interactions:

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

Pharmacological Class:

Imidazopyridine hypnotic.

Adverse Reactions:

CNS effects (eg, hallucinations, agitation, behavioral changes, depersonalization, amnesia), complex sleep-related behaviors (eg, sleep-driving), headache, drowsiness, dizziness, diarrhea, anaphylaxis, angioedema; others.

Generic Availability:

NO

How Supplied:

SL tabs—30

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