Zolpidem sublingual tablet
What is this medicine?
ZOLPIDEM (zole PI dem) is used to treat insomnia. Edluar is for use when you have trouble falling asleep when you first go to bed. Intermezzo is for use when you have trouble returning to sleep after waking in the middle of the night.
How should I use this medicine?
Place this medicine under your tongue and let it dissolve. Do not swallow it or take it with water. Follow the directions on the prescription label. Take this medicine on an empty stomach. Do not take your medicine more often than directed. If you have been taking this medicine for several weeks and suddenly stop taking it, you may get unpleasant withdrawal symptoms. Your doctor or health care professional may want to slowly lower the dose. Do not stop taking this medicine on your own. Always follow your doctor or health care professional's advice.
Edluar brand: This medicine will help you fall asleep. You will only take the medicine right before you get into bed. Take only when you are able to stay in bed a full night (7 to 8 hours) before being active again.
Intermezzo brand: This medicine is used to help you return to sleep after waking in the middle of the night. Only take it if you have at least 4 hours of bedtime remaining. Place a single Intermezzo pouch by your bed. Store all other unopened Intermezzo pouches and other medicines away from your bedside. Only open the Intermezzo pouch when you are ready to use it. If needed, use one of the dosing time tools that come with your prescription to find the latest time of night you can take your dose. After taking the dose, leave the empty medicine pouch where you can see it to help remind you that the dose has already been taken. Throw the empty pouch away in the morning.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Patients over 65 years old may have a stronger reaction and need a smaller dose.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
changes in vision
depressed mood or other changes in moods or emotions
feeling faint or lightheaded, falls
loss of balance or coordination
loss of memory
numbness or tingling of the tongue
restlessness, excitability, or feelings of anxiety or agitation
signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
unusual activities while asleep like driving, eating, making phone calls, or sexual activity
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
drowsiness the day after you take this medicine
What may interact with this medicine?
antihistamines for allergy, cough and cold
certain medicines for anxiety or sleep
certain medicines for depression, like amitriptyline, fluoxetine, sertraline
certain medicines for fungal infections like ketoconazole and itraconazole
certain medicines for seizures like phenobarbital, primidone
dietary supplements for sleep, like valerian or kava kava
general anesthetics like halothane, isoflurane, methoxyflurane, propofol
local anesthetics like lidocaine, pramoxine, tetracaine
medicines that relax muscles for surgery
narcotic medicines for pain
phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
What if I miss a dose?
This medicine should only be taken immediately before going to sleep (Edluar brand) or when you have trouble returning to sleep after waking in the middle of the night (Intermezzo brand). You will only take one dose per night. Do not take double or extra doses.
Where should I keep my medicine?
Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.
This medicine may cause accidental overdose and death if taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
history of drug abuse or addiction
if you often drink alcohol
lung or breathing disease
suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
an unusual or allergic reaction to zolpidem, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. Talk to your doctor if your insomnia worsens or is not better within 7 to 10 days.
After taking this medicine for sleep, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may have no memory of the event. Activities such as driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking have been reported. Call your doctor right away if you find out you have done any of these activities. Do not take this medicine if you have used alcohol that evening or before bed or taken another medicine for sleep since your risk of doing these sleep-related activities will be increased.
When using this medicine for help with trouble falling asleep (Edluar tablets), do not take it unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. When using this medicine for middle-of-the-night awakening (Intermezzo tablets), do not take it with less than 4 hours of bedtime remaining. Tell your doctor if you will need to perform activities requiring full alertness, such as driving, the next day. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Do not stand or sit up quickly after taking this medicine, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
If you or your family notice any changes in your moods or behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your doctor right away.
After you stop taking this medicine, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.
July 17, 2018