Uses

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).

How To Use

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.

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.

Side Effects

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.

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.

Precautions

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).

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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).

Caution is advised when using this drug in infants/young children because they may be at risk for lung infection due to difficulty swallowing that leads 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 breast-feeding.

Drug Interactions

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:

• orlistat
• sodium oxybate
• drugs affecting liver enzymes that remove nitrazepam from your body (such as cimetidine, macrolide antibiotics including erythromycin)

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.

Overdose

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 their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme drowsiness, confusion, decreased muscle reflexes.

Notes

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.

Missed Dose

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.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medicines 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.