What should I watch for?
Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse.
Do not stop taking except on your doctor's advice. You may develop a severe reaction. Your doctor will tell you how much medicine to take.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce the risk of dizzy and fainting spells, do not stand or sit up quickly, especially if you are an older patient. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.
If you are taking another medicine that also causes drowsiness, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing or unusual sleepiness.
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 drink alcohol or have taken another medicine for sleep, since your risk of doing these sleep-related activities will be increased.
Do not take this medicine unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Tell your doctor if you will need to perform activities requiring full alertness, such as driving, the next day. 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 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.
Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.
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:
Absence of or decrease in body movement
clumsiness or unsteadiness
sleepiness or unusual drowsiness
Aggressive or angry
blood in the urine
bloody, black, or tarry stools
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
decrease in the amount of urine
decreased awareness or responsiveness
deep or fast breathing with dizziness
difficult or labored breathing
dryness or soreness of throat
false or unusual sense of well-being
fast, irregular, pounding, or racing heartbeat or pulse
fear or nervousness
feeling of warmth
frequent strong or increased urge to urinate
increased urge to urinate during the night
lack of feeling or emotion
loss of bladder control
loss of memory
mouth sores or ulcers
muscle spasm or jerking of all extremities
numbness of the feet, hands, and around mouth
problems with memory
quick to react or overreact emotionally
rapidly changing moods
redness of the face, neck, arms, and occasionally, upper chest
seeing, hearing, or feeling things that are not there
severe stomach pain
shakiness and unsteady walk
shakiness in the legs, arms, hands, or feet
shortness of breath
sores, ulcers, or white spots on the lips or in the mouth
sudden loss of consciousness
swollen lymph nodes
tightness in the chest
trouble in swallowing
uncontrolled eye movements
unsteadiness, trembling, or other problems with muscle control or coordination
unusual bleeding or bruising
unusual tiredness or weakness
waking to urinate at night
Incidence not known
Blistering, peeling, or loosening of the skin
fever with or without chills
general feeling of tiredness or weakness
joint or muscle pain
lower back or side pain
red, irritated eyes
red skin lesions, often with a purple center
unable to sleep
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:
Lack or loss of strength
Pain in the legs or feet
Blemishes on the skin
burning feeling in the chest or stomach
change in color vision
change in taste bad unusual or unpleasant (after) taste
changes in vision, especially night blindness
continuing ringing or buzzing or other unexplained noise in the ears
cramping in the lower abdomen, back, or legs
decreased interest in sexual intercourse
difficulty having a bowel movement (stool)
difficulty in moving
difficulty seeing at night
ear or eye pain
excess air or gas in stomach or intestines
glare or snowy image caused by bright light
hives or welts
inability to have or keep an erection
increased or decreased appetite
increased sensitivity of eyes to sunlight
loss in sexual ability, desire, drive, or performance
muscle pains or stiffness
pain in the arms, jaw, or neck
pain or tenderness around the eyes and cheekbones
pain, swelling, or redness in joints
red, sore eyes
redness of the skin
stuffy or runny nose
swelling of the breasts
tenderness in stomach area
weight gain or loss
white or brownish vaginal discharge
Incidence not known
Increased sensitivity of skin to sunlight
redness or other discoloration of skin
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.