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 you still have trouble sleeping within 7 to 10 days of using this medicine. This may mean there is another cause for your sleep problems.
Do not take this medicine unless you are able to get a full night of sleep before you must be active again. After taking this medicine, do not drive, use machinery, or do anything that needs mental alertness. Take this medicine only within 30 minutes of going to bed and then confine your activities to those needed to get ready for sleep. You may still feel drowsy the next day after taking this medicine. If this happens, do not drive, use machinery, or do anything that needs mental alertness until you feel fully awake. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
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.
Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.
This medicine can cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
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:
Incidence not known
Abdominal or stomach pain
agitation
black, tarry stools
bleeding gums
blood in the urine or stools
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chills
clay-colored stools
cold sweats
confusion about identity, place, and time
convulsions
cool, pale skin
cough or hoarseness
dark urine
decrease in the frequency of urination
decrease in urine volume
decreased urine output
difficulty in passing urine (dribbling)
difficulty with breathing
difficulty with speaking
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fast, pounding, or irregular heartbeat or pulse
feeling of warmth
flushed, dry skin
fruit-like breath odor
general feeling of tiredness or weakness
headache
hearing loss
hostility
increased hunger
increased thirst
increased urination
irritability
itching or rash
lethargy
lip smacking or puckering
loss of appetite
loss of balance control
loss of bladder control
lower back or side pain
mood or mental changes
muscle spasm or jerking of all extremities
muscle trembling, jerking, or stiffness
muscle twitching
nervousness
nightmares
noisy breathing
painful or difficult urination
pinpoint red spots on the skin
pounding in the ears
puffing of the cheeks
rapid or worm-like movements of the tongue
rapid weight gain
redness of the face, neck, arms, and occasionally, upper chest
restlessness
ringing or buzzing or other unexplained noise in the ears that continues
seeing, hearing, or feeling things that are not there
seizures
shakiness and unsteady walk
shakiness in the legs, arms, hands, or feet
shuffling walk
sores, ulcers, or white spots on the lips, tongue, or in the mouth
slurred speech
stiffness of the limbs
stupor
sudden loss of consciousness
sweating
swelling of the face, ankles, or hands
swollen glands
tightness in the chest
troubled breathing
twisting movements of the body
uncontrolled chewing movements
uncontrolled movements, especially of the arms, face, legs, neck, and back
unexplained weight loss
unpleasant breath odor
unsteadiness, trembling, or other problems with muscle control or coordination
unusual bleeding or bruising
unusual tiredness or weakness
vomiting of blood
yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Clumsiness
disturbed concentration
drowsiness
enlarged pupils
increased or excessive unconscious or jerking movements
low body temperature
muscle aches
muscle weakness
shivering
sleepiness
weak or feeble pulse
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:
Incidence not known
Change in taste or bad, unusual or unpleasant (after) taste
decreased interest in sexual intercourse
difficulty having a bowel movement (stool)
enlargement of the breasts
gas in the stomach
hair loss or thinning of the hair
inability to have or keep an erection
increased in sexual ability, desire, drive, or performance
increased interest in sexual intercourse
increased sensitivity of the skin to sunlight
loss in sexual ability, desire, drive, or performance
redness or other discoloration of the skin
severe sunburn
swelling of the breasts or breast soreness in both females and males
swelling of the testicles
unexpected or excess milk flow from breasts
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.
