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. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. 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 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.
Do not take this medicine unless you are able to stay in bed for a full night (7 to 8 hour) 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:
increased muscle spasm
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
unusual excitement, nervousness, restlessness, or irritability
Incidence not known
Abdominal or stomach pain
changes in patterns and rhythms of speech
decrease in frequency of urination
decrease in urine volume
difficulty in passing urine (dribbling)
inability to move the eyes
increased blinking or spasms of the eyelid
itching or rash
loss of appetite
loss of bladder control
shakiness in the legs, arms, hands, or feet
sticking out of the tongue
trembling or shaking of the hands or feet
trouble in speaking or swallowing
uncontrolled twisting movements of the neck, trunk, arms, or legs
unpleasant breath odor
unusual facial expressions
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
Change in consciousness
loss of consciousness
mood or mental changes
sleepiness or unusual drowsiness
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:
Acid or sour stomach
stomach discomfort or upset
Incidence not known
Decreased interest in sexual intercourse
inability to have or keep an erection
increased in sexual ability, desire, drive, or performance
increased interest in sexual intercourse
loss in sexual ability, desire, drive, or performance
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.