Important Safety Information for Patients
When Taking EDLUAR Sublingual Tablets
- Allergic reactions such as sudden trouble breathing, swelling of your tongue or throat may occur and in rare cases may be fatal. If you are allergic to zolpidem tartrate or any of EDLUAR's inactive ingredients, don't take this product. If you have an allergic reaction while using EDLUAR, do not take another dose and contact your doctor immediately.
- EDLUAR can be taken for 7 to 10 days or as advised by your doctor. If your sleep problems continue, consult your doctor, who will determine whether another condition is causing your sleep problem or other measures are needed to treat your sleep problems.
- Sleepwalking, eating, driving or doing other activities while not fully awake, with memory loss for the event, as well as abnormal behaviors such as being more outgoing or aggressive than normal, confusion, agitation, and hallucinations may occur. Using EDLUAR with alcohol or other medicines that can make you sleepy can increase the risk
of these behaviors.
- EDLUAR can impair your alertness and motor coordination. After taking EDLUAR,
don't drive or operate machinery until you are fully awake.
- Don't take EDLUAR with alcohol.
- Because EDLUAR works quickly, you should take EDLUAR immediately
before going to bed.
- In patients with depression, worsening of depression (including suicidal thoughts, actions, and completed suicides) may occur. If your depression worsens, contact your doctor immediately.
- The most commonly observed side effects in controlled clinical trials were next-day drowsiness, dizziness, headache, diarrhea, and drugged feelings.
- EDLUAR is a federally controlled substance and can be abused or lead to dependence. After you stop taking EDLUAR, you may have symptoms for 1 to 2 days, such as trouble sleeping, nausea and vomiting, flushing, lightheadedness, and nervousness.
- When taking EDLUAR, stay in bed for a full night (7 to 8 hours) before you
must be active again.
You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Please visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information and Medication Guide