This medication is used by adults for the short-term
treatment of trouble sleeping (insomnia). It may help you fall asleep
faster and decrease the number of times you awaken during the night. It may
also help you sleep for a longer time. Nitrazepam is also used by children
and infants to treat a certain type of seizure (myoclonic).
This medication belongs to a class of drugs called
benzodiazepines, which act on the brain to produce a calming effect. It
works by enhancing the effects of a certain natural chemical in the body
(GABA).
See also Warning section.
To treat insomnia, take this medication by mouth with or
without food as directed by your doctor, usually before bedtime. This
medication can be chewed or dissolved in liquid if you are unable to
swallow it whole.
Do not use this medication if you have less than 7 to 8
hours to sleep. Doing so increases the risk of daytime drowsiness and
temporary memory loss.
To treat seizures in infants and children, give the
medication by mouth as directed by your doctor, usually 3 times a
day.
The dosage is based on your medical condition and
response to treatment. Nitrazepam is not usually used for more than 7 to 10
days when treating insomnia. Long-term use can cause the medication to
build up in your body, increase side effects, and cause dependence. It can
make your insomnia worse after you stop taking the medication (rebound
insomnia).
Though it helps many people, this medication may
sometimes cause addiction. This risk may be higher if you have a substance
use disorder (such as overuse of or addiction to drugs/alcohol). Do not
increase your dose, take it more often, or use it for a longer time than
prescribed. Properly stop the medication when so directed.
When used for an extended period, this medication may
not work as well and may require different dosing. Talk with your doctor if
this medication stops working well.
Tell your doctor if you continue to have trouble
sleeping or your child's seizures last or get worse.
See also Warning section.
Drowsiness, dizziness, loss of coordination, headache,
lightheadedness, nightmares, trouble walking, or falling may occur. To
reduce the risk of injury from falling, take this medication right before
going to bed. If any of these effects last or get worse, tell your doctor
or pharmacist promptly.
This medication may make you sleepy during the day. Tell
your doctor if you have daytime drowsiness. Your dose may need to be
adjusted. Some people, particularly children, may experience excitability
rather than drowsiness.
To reduce the risk of dizziness and lightheadedness, get
up slowly when rising from a sitting or lying position.
Remember that this medication has been prescribed
because your doctor has judged that the benefit to you is greater than the
risk of side effects. Many people using this medication do not have serious
side effects.
Tell your doctor right away if you have any serious side
effects, including:
- nausea/vomiting that doesn't stop
- mental/mood changes (such as confusion, hallucinations,
agitation, anxiety, depression, thoughts of suicide)
- memory problems
- fast/pounding/irregular heartbeat
- fainting
- muscle spasms
- dark urine
- stomach/abdominal pain
- yellowing eyes/skin
- signs of infection (such as sore throat that doesn't go away,
fever)
Rarely, after taking this drug, people have gotten out
of bed and driven vehicles while not fully awake ("sleep-driving"). People
have also sleepwalked, prepared/eaten food, made phone calls, or had sex
while not fully awake. Often, these people do not remember these events.
This problem can be dangerous to you or to others. If you find out that you
have done any of these activities after taking this medication, tell your
doctor right away. Your risk is increased if you use alcohol or other
medications that can make you drowsy while taking
nitrazepam.
A very serious allergic reaction to this drug is rare.
However, get medical help right away if you notice any symptoms of a
serious allergic reaction, including:
- rash
- itching/swelling (especially of the face/tongue/throat)
- severe dizziness
- trouble breathing
This is not a complete list of possible side effects. If
you notice other effects not listed above, contact your doctor or
pharmacist.
In the US - Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088 or at
www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about
side effects. You may report side effects to Health Canada at
1-866-234-2345.
Before taking nitrazepam, tell your doctor or pharmacist
if you are allergic to it; or to other benzodiazepines (such as diazepam,
temazepam); or if you have any other allergies. This product may contain
inactive ingredients, which can cause allergic reactions or other problems.
Talk to your pharmacist for more details.
Before using this medication, tell your doctor or
pharmacist your medical history, especially of:
- breathing problems (such as asthma, chronic obstructive
pulmonary disease-COPD, sleep apnea)
- a certain muscle disorder (myasthenia gravis)
- mental/mood disorders (such as uncontrolled aggression/anger,
depression, moderate/severe personality disorder)
- personal or family history of a substance use disorder (such
as overuse of or addiction to drugs/alcohol)
- kidney disease
- liver disease
- stroke
- an unusual reaction to drugs that cause calmness/drowsiness
(such as excitement, agitation, hallucinations)
This drug may make you dizzy or drowsy. Alcohol or
marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use
machinery, or do anything that needs alertness until you can do it safely.
Avoid alcoholic beverages. Talk to your doctor if you are using marijuana
(cannabis).
Before having surgery, tell your doctor or dentist about
all the products you use (including prescription drugs, nonprescription
drugs, and herbal products).
Older adults may be more sensitive to the side effects
of this drug, especially memory problems and increased risk of falls (due
to drowsiness, dizziness, and loss of coordination).
Infants/young children may be at risk for lung infection
due to difficulty swallowing, which may lead to saliva getting in the lungs
(aspiration).
Tell your doctor if you are pregnant or plan to become
pregnant. You should not become pregnant while using nitrazepam. Nitrazepam
may harm an unborn baby. Newborn babies of mothers who use this medication
late in pregnancy may have symptoms such as slow/shallow breathing, nonstop
crying, shaking, or trouble feeding. If you become pregnant, talk to your
doctor right away about the risks and benefits of this
medication.
It is unknown if this drug passes into breast milk.
However, similar drugs pass into breast milk. Consult your doctor before
breastfeeding.
See also Warning section.
Drug interactions may change how your medications work
or increase your risk for serious side effects. This document does not
contain all possible drug interactions. Keep a list of all the products you
use (including prescription/nonprescription drugs and herbal products) and
share it with your doctor and pharmacist. Do not start, stop, or change the
dosage of any medicines without your doctor's approval.
Some products that may interact with this drug
are:
Other medications can affect the removal of nitrazepam
from your body, which may affect how nitrazepam works. Examples include
cimetidine, macrolide antibiotics (such as erythromycin), among
others.
The risk of serious side effects (such as slow/shallow
breathing, severe drowsiness/dizziness) may be increased if this medication
is taken with other products that may also cause drowsiness or breathing
problems. Tell your doctor or pharmacist if you are taking other products
such as opioid pain or cough relievers (such as codeine, hydrocodone),
alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as
alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol,
cyclobenzaprine), or antihistamines (such as cetirizine,
diphenhydramine).
Check the labels on all your medicines (such as allergy
or cough-and-cold products) because they may contain ingredients that cause
drowsiness. Ask your pharmacist about using those products
safely.
If someone has overdosed and has serious symptoms such
as passing out or trouble breathing, call 911. Otherwise, call a poison
control center right away. US residents can call 1-800-222-1222. Canada
residents can call 1-844-764-7669. Symptoms of overdose may include:
extreme drowsiness, confusion, decreased muscle reflexes.
Do not share this medication with others. Sharing it is
against the law.
Consult your doctor or pharmacist for ways to improve
your sleep without medication, such as avoiding caffeine and alcohol close
to bedtime, avoiding daytime naps, and avoiding going to bed too early each
night.
This medication has been prescribed for your current
condition only. Do not use it later for another condition unless told to do
so by your doctor. A different medication may be necessary in that
case.
If you are using this medication to treat seizures and
miss a dose, give it as soon as you remember. If it is near the time of the
next dose, skip the missed dose. Give your child the next dose at the
regular time. Do not double the dose to catch up. If you are using this
medication for trouble sleeping and miss a dose, take it as soon as you
remember. If you do not have 8 hours to sleep, skip the missed dose. Take
your next dose at the regular time.
Store at room temperature away from light and moisture.
Do not store in the bathroom. Keep all medications away from children and
pets.
Do not flush medications down the toilet or pour them
into a drain unless instructed to do so. Properly discard this product when
it is expired or no longer needed. Consult your pharmacist or local waste
disposal company.