This medicine is a sedative-hypnotic, or sleep medicine, used for short-term treatment of insomnia (trouble falling back asleep after waking in the middle of the night).
Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE BY MOUTH. Do not take it with or right after a meal because it may not work as well. DO NOT SWALLOW THIS MEDICINE WHOLE. Place the tablet under your tongue and allow it to slowly dissolve. Do not crush or chew this medicine. Do NOT take this medicine with water. Do not eat, drink, or smoke while the tablet is dissolving. TAKE THIS MEDICINE WHILE IN BED as directed by your doctor. Do not use more than 1 dose of this medicine on the same night. ONLY USE THIS MEDICINE when you will be able to get at least 4 more hours of sleep before your planned time of waking. You may use the included Dosing Time Chart or Dosing Time Tool to help you find the latest time during the night that you can take this medicine. Do NOT handle the tablet with wet or damp hands. Do NOT open the pouch until you are ready to take this medicine. Use the tablet immediately after opening the pouch. Do not store the removed tablet for future use. TO REMOVE THIS MEDICINE FROM THE POUCH, fold along the dotted line. While the pouch is folded, tear the pouch open at the notch at the center of the dotted line. Remove the foil blister from the pouch, and push the tablet through the foil. LEAVE THE EMPTY POUCH WHERE YOU CAN SEE IT. This will help remind you that you have taken your dose. DO NOT STORE MORE THAN 1 POUCH containing this medicine at your bedside. Store all other unopened pouches away from your bedside. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. This medicine is usually used as needed. IF YOU FORGET TO USE A DOSE OF THIS MEDICINE and you are able to get at least 4 more hours of sleep, use it when you remember as directed by your doctor. Do not take more than your total daily dose in any 24-hour period.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking sodium oxybate (GHB) or another medicine to help you sleep, including any other medicine that contains zolpidem. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking benzodiazepines (eg, diazepam), chlorpromazine, HIV protease inhibitors (eg, ritonavir), imipramine, ketoconazole, narcotic pain medicines (eg, hydrocodone, codeine), rifampin, sertraline, or tricyclic antidepressants (eg, amitriptyline). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including kidney or liver problems, lung or breathing problems (eg, chronic obstructive pulmonary disease / COPD, sleep apnea), myasthenia gravis, metabolism problems, heart or blood pressure problems, very poor health, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of mood or mental problems (eg, depression), suicidal thoughts or behaviors, or alcohol or substance abuse or addiction. This medicine should not be used in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed. Children may be more sensitive to this medicine's side effects, especially dizziness, headache, and hallucinations. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include dizziness, drowsiness (including daytime drowsiness), "drugged" feeling, headache, nausea, or tiredness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thinking; behavior changes; chest pain; confusion; decreased coordination; fainting; fast or irregular heartbeat; hallucinations; memory problems (eg, memory loss); new or worsening mental or mood changes (eg, aggression, agitation, anxiety, depression); severe dizziness; severe or persistent nausea or vomiting; shortness of breath; suicidal thoughts or actions; or vision changes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, eyes, throat, or tongue; throat closing; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe drowsiness or coma.
THIS MEDICINE IS USUALLY USED ONLY FOR A SHORT PERIOD OF TIME. If your symptoms do not get better within 7 to 10 days or if they get worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.