Generic Name: zolpidem (ZOL-pi-dem)
Brand Name: Zolpimist
Zolpidem spray is used for:
Short-term treatment of insomnia (trouble falling asleep).
Zolpidem spray is a sedative-hypnotic, or sleep medicine. It works by helping to increase certain natural chemicals in the brain that cause sleep.
Do NOT use zolpidem spray if:
- you are allergic to any ingredient in zolpidem spray or to any other medicine that has zolpidem in it
- you are taking another medicine to help you sleep, including any other medicine that has zolpidem in it
- you are taking sodium oxybate (GHB)
Contact your doctor or health care provider right away if any of these apply to you.
Before using zolpidem spray:
Some medical conditions may interact with zolpidem spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have 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, or very poor health
- if you have a history of mood or mental problems (eg, depression), suicidal thoughts or behaviors, or alcohol or substance abuse or addiction
- if you are a child or teenager with a history of attention deficit hyperactivity disorder (ADHD)
Some MEDICINES MAY INTERACT with zolpidem spray. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Benzodiazepines (eg, diazepam), chlorpromazine, HIV protease inhibitors (eg, ritonavir), ketoconazole, narcotic pain medicines (eg, hydrocodone, codeine), perampanel, sertraline, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline, imipramine) because they may increase the risk of zolpidem spray's side effects
- Rifampin because it may decrease zolpidem spray's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if zolpidem spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use zolpidem spray:
Use zolpidem spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Zolpidem spray comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get zolpidem spray refilled.
- Take zolpidem spray by mouth on an empty stomach at least 2 hours after a meal.
- Zolpidem spray works very quickly; use zolpidem spray right before going to sleep.
- Use zolpidem spray only when you are able to get a full night's sleep (7 to 8 hours).
- Zolpidem spray needs to be primed before you use it for the first time. To prime zolpidem spray, remove the child-resistant cap and inner clear protective cap. Point the spray opening away from your face and other people. Fully press down on the pump with your finger. Release and let the pump return to starting position. Repeat these steps 4 more times. You should see a fine spray. The medicine is now ready to use.
- If zolpidem spray has not been used within the last 14 days, reprime before using by pressing down 1 time on the pump.
- To use zolpidem spray, open your mouth and hold the container upright with the spray opening pointed directly into your mouth. Press all the way down on the pump and let the medicine spray directly into your mouth over your tongue. If your dose requires a second spray, repeat these steps. Keep the spray away from your eyes. Put the clear protective cap and child-resistant cap back on after each use.
- Discard zolpidem spray after 60 sprays have been used.
- If you miss a dose of zolpidem spray, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than your total daily dose in any 24-hour period.
Ask your health care provider any questions you may have about how to use zolpidem spray.
Important safety information:
- Zolpidem spray may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use zolpidem spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not take zolpidem spray if you drink alcohol that day or before bed, or if you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using zolpidem spray; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Zolpidem spray may cause a "carryover" effect on you the day after you take it. The risk may be increased if you take it with less than a full night's sleep (7 to 8 hours), if you take more than the recommended dose, or if you take it with certain other medicines. Do not drive or perform other tasks where you need to think clearly until you are fully alert. Discuss any questions or concerns with your doctor.
- Zolpidem spray 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.
- Some patients taking zolpidem spray have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of zolpidem spray. It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use zolpidem spray. Tell your doctor right away if such an event happens to you.
- Zolpidem spray may cause drowsiness and lowered level of alertness. This may lead to falls and injuries that may be severe. Severe injuries (eg, hip fracture, bleeding in the brain) have happened. Discuss any questions or concerns with your doctor.
- Use zolpidem spray with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness or drowsiness.
- Zolpidem spray should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. Children may be more sensitive to zolpidem spray's side effects, especially dizziness, headache, and hallucinations.
- PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using zolpidem spray while you are pregnant. Zolpidem spray may cause prolonged sleep or severe breathing problems in the newborn if you take it during the last weeks of pregnancy, especially if you take it with certain medicines. Zolpidem spray is found in breast milk. If you are or will be breast-feeding while you use zolpidem spray, check with your doctor. Discuss any possible risks to your baby.
When sleep medicines are used every night for more than a few weeks, they may lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should usually be used only for short periods of time, such as a few days, and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your doctor.
When used for longer than a few weeks or at high doses, some people develop a need to continue taking zolpidem spray. This is known as DEPENDENCE or addiction. Be sure to tell your doctor if you have been dependent on alcohol, prescription medicines, or street drugs in the past.
If you stop taking zolpidem spray suddenly, you may have WITHDRAWAL symptoms. This may include unpleasant feelings. In more severe cases, you may have stomach and muscle cramps, vomiting, sweating, and shakiness. Seizures may rarely occur. If you take zolpidem spray for more than 1 to 2 weeks, do not stop taking it without talking to your doctor.
Possible side effects of zolpidem spray:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; dizziness; drowsiness (including daytime drowsiness); "drugged" feeling; dry mouth; headache; nausea; nose or throat irritation; stomach upset; tiredness; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, eyes, throat, or tongue; throat closing; unusual hoarseness); abnormal thinking; behavior changes; breathing problems; chest pain; confusion; decreased coordination; fainting; fast or irregular heartbeat; hallucinations; memory problems (eg, memory loss); mental or mood changes (eg, aggression, agitation, anxiety); new or worsening depression; severe dizziness or light-headedness; severe or persistent nausea or vomiting; shortness of breath; suicidal thoughts or actions; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of zolpidem spray:
Store zolpidem spray at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Avoid prolonged storage above 86 degrees F (30 degrees C). Store zolpidem spray upright and away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep zolpidem spray out of the reach of children and away from pets.
- If you have any questions about zolpidem spray, please talk with your doctor, pharmacist, or other health care provider.
- Zolpidem spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take zolpidem spray or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about zolpidem spray. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to zolpidem spray. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using zolpidem spray.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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