What should I watch for?
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.
Common and Rare Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Clumsiness or unsteadiness
Difficulty with breathing
dizziness, lightheadedness, or fainting
seeing, hearing, or feeling things that are not there
swelling of the face
unusual excitement, nervousness, or irritability
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Sleepiness or unusual drowsiness
Abdominal or stomach pain
abnormal or decreased touch sensation
abnormal sensation of movement
bloody or cloudy urine
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
change in hearing
confusion about identity, place, and time
continuous ringing, buzzing, or other unexplained noise in the ears
difficult, burning, or painful urination
difficulty with moving
difficulty with swallowing
false or unusual sense of well-being
feeling of unreality
feeling sad or empty
frequent bowel movements
frequent urge to urinate
hives or welts
lack of appetite
lack of feeling or emotion
lack or loss of self-control
lack or loss of strength
longer or heavier menstrual periods
loss of balance
loss of interest or pleasure
muscle aches, cramping, pain, or stiffness
nightmares or unusual dreams
redness of the skin
redness or soreness of the throat
sense of detachment from self or body
slowing of mental and physical activity
stuffy or runny nose
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.