Important Safety Information for
Patients Taking EDLUAR
- EDLUAR is contraindicated in patients with known hypersensitivity to all forms of zolpidem tartrate or to any inactive ingredient in its formulation. Severe anaphylactic and anaphylactoid reactions have been reported. Rare cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after the first or subsequent doses of sedative/hypnotics, including zolpidem tartrate. Airway obstruction may occur and may be fatal. Patients who develop angioedema should not be rechallenged with the drug.
- Insomnia that fails to remit after 7 to 10 treatment days may indicate a primary psychiatric and/or medical illness that should be evaluated.
- Abnormal behaviors such as somnambulism, driving and/or eating while not fully awake, with amnesia for the event, and behavioral changes like abnormal aggressiveness and extroversion, confusion, agitation, and hallucinations have been reported in patients who have taken a sedative/hypnotic, including zolpidem tartrate. Strongly consider discontinuation of EDLUAR for patients reporting such behaviors.
- EDLUAR should be used with caution in patients with signs or symptoms of depression. In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with sedative/hypnotic use. The least amount of drug that is feasible should be prescribed for the patient at any one time.
- Following abrupt discontinuation, sedative/hypnotics have produced withdrawal signs and symptoms (ranging from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions).
- Due to its rapid onset of action, EDLUAR should be taken immediately before going to bed. EDLUAR can impair alertness and motor coordination. In combination with other CNS depressants, dose reductions may be needed due to additive effects. EDLUAR should not be used with alcohol. Caution patients against driving or doing any dangerous activity until they feel fully awake.
- In elderly/debilitated patients, use a lower dose to minimize adverse events related
to impaired motor and/or cognitive performance after repeated exposure,
and increased sensitivity.
- EDLUAR should be used with caution and close monitoring in patients with hepatic impairment, mild to moderate COPD, impaired drug metabolism or hemodynamic responses, and mild to moderate sleep apnea.
- During short-term treatment (<10 nights), the most common adverse events in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%).
- During long-term treatment (28-35 nights), the most common adverse events were dizziness (5%) and drugged feelings (3%).
- EDLUAR is a Schedule IV controlled substance. Patients with a history of addiction/substance abuse have increased dependency risk and should be monitored carefully when receiving EDLUAR or any other hypnotic.
Please See Full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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