Sandoz Nitrazepam

How does this medication work? What will it do for me?

Nitrazepam belongs to the class of medications called benzodiazepines. It is used for short-term treatment of sleeping problems (insomnia), such as difficulty falling asleep, frequent awakenings during the night, and early-morning awakening. It is also used to manage myoclonic seizures. It works by slowing down the nerves in the brain (the central nervous system).

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

How should I use this medication?

The recommended adult dose of nitrazepam when taken for insomnia is 5 mg to 10 mg taken at bedtime.

Seniors may be more likely to experience unwanted effects of this medication and should start with 2.5 mg taken at bedtime.

The lowest effective dose should be used. It is important that the dose be individualized to your specific needs to avoid excessive drowsiness during the day time or motor impairment.

This medication is normally used for a short period of time or as an "as required" medication. As it may be habit-forming, the treatment period should be as short as possible and not usually longer than 7 to 10 consecutive days. If you need this medication for more than 2 to 3 weeks, consult your doctor for a re-evaluation of this medication.

When taken for treatment of myoclonic seizures, the dose is based primarily on body weight. The dose for children (up to 30 kg of body weight) ranges from 0.3 mg per kilogram of body weight to 1 mg per kilogram of body weight daily in 3 divided doses. Your doctor will calculate an appropriate dose.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Nitrazepam may be habit-forming when taken for long periods of time. It may not be appropriate for people who have a history of alcohol or substance abuse.

If you have been taking this medication regularly, even for a short period of time, do not stop taking the medication without speaking with your doctor. A gradual reduction in dose is recommended when stopping this medication to avoid withdrawal effects.

It is important to take this medication exactly as prescribed by your doctor. Do not take this medication in a larger amount or for a longer period of time than prescribed by your doctor. If you miss a scheduled dose, take it as soon as possible and continue with your regular schedule. If you are taking nitrazepam for sleeping, do not take it if you will not be able to get a full night's sleep (approximately 8 hours or more). This medication tends to make people disoriented, uncoordinated, and unable to concentrate clearly until it has worn off. If you remember the missed dose during the daytime, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take nitrazepam if you:

• are allergic to nitrazepam or any ingredients of this medication
• are allergic to other benzodiazepines
• are a child and using nitrazepam to treat insomnia
• have myasthenia gravis
• have severely decreased liver function
• have sleep apnea

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• clumsiness or unsteadiness
• dizziness
• drowsiness
• increased watering of mouth
• lightheadedness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• agitation
• anxiety
• behavioural changes, including aggressiveness, angry outbursts, bizarre behaviour, or decreased inhibitions
• confusion
• falls and injuries, including fractures
• hallucinations (hearing or seeing things that aren’t there)
• hyperactivity
• increased trouble sleeping
• irritability
• memory problems
• muscle spasms
• shortness of breath
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• sleepwalking
• unusual excitement, nervousness, or irritability
• unusual tiredness or weakness (severe)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• convulsions (seizures)
• signs of a serious allergic reaction (i.e., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• slow, weak, or shallow breathing
• symptoms of overdose (e.g., extreme sleepiness, confusion, slurred speech, slow reflexes, slow shallow breathing, loss of balance and coordination, uncontrolled eye rolling, low blood pressure, coma)
• symptoms of withdrawal (e.g., feeling like you cannot move or respond, severe confusion, shivering, irregular heart rate and excessive sweating, feeling disconnected from reality, seeing or hearing things that aren’t there, believing things that aren’t true)
• thoughts of self-harm or suicide

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol and other medications that cause drowsiness: People taking this medication should not combine it with alcohol and avoid combining it with other medications, such as narcotic pain relievers, or other sedatives that cause drowsiness. Doing so can cause additional drowsiness and reduced breathing as well as other side effects, which can be dangerous and possibly fatal.

Asthma and other respiratory conditions: Nitrazepam may cause increased breathing difficulty for people having an acute asthma attack, or those with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) or other conditions that affect breathing. If you have asthma or any other breathing disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Behavioural and mood changes: This medication may cause mood and psychiatric changes, including aggressiveness, confusion, anxiety, restlessness, and memory lapses. Tell your doctor as soon as possible if you notice any unusual changes in your behaviour.

Complex sleep-related behaviours: There have been reports of complex sleep-related behaviours that have occurred while using nitrazepam and other similar medications to treat difficulty sleeping. People taking nitrazepam have been reported to talk, walk, cook, eat, and drive while they were not fully awake, and did not remember doing these things afterwards. If you experience similar events, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Dependence and withdrawal: Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with benzodiazepines such as nitrazepam. People who have a history of dependence on alcohol or other medications may be more at risk of developing dependence on nitrazepam.

Severe withdrawal symptoms may be experienced if the dose is significantly reduced or suddenly discontinued. These symptoms include seizures, irritability, nervousness, sleep problems, agitation, tremors, diarrhea, abdominal cramps, vomiting, memory impairment, headache, muscle pain, extreme anxiety, tension, restlessness, and confusion. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms.

A temporary condition called rebound insomnia, where the symptoms that led to treatment with nitrazepam come back worse than before, may occur on withdrawal of the medication. It may be accompanied by other reactions including mood changes or anxiety.

Depression: This medication can make some symptoms of depression worse. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, or decreased interest in activities, contact your doctor as soon as possible. If you experience feelings of wanting to harm yourself, or notice this in a family member who is taking this medication, seek medical help immediately.

Drowsiness/reduced alertness: Nitrazepam causes drowsiness and sedation. Avoid activities requiring mental alertness, judgment, and physical coordination such as driving or operating machinery until you have determined how this medication affects you. Drinking alcohol can increase the drowsiness effects and should be avoided.

Falls and injuries: Nitrazepam can cause drowsiness or dizziness that can affect your balance and increase your risk of falling. This can result in fractures or other injuries. Your risk of falls is increased if you drink alcohol or take other sedatives while taking this medication, you are elderly or have a condition that causes weakness or frailty.

Kidney function: If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: People with reduced liver function or liver disease may experience a stronger effect from the medication than would normally occur. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: Nitrazepam, like other benzodiazepines, can cause harm to an unborn baby if the mother takes it while pregnant. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are breast-feeding and are taking nitrazepam, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of nitrazepam for sleep difficulties have not been established for children and adolescents less than 18 years of age.

Seniors: Seniors are more likely to experience sedation and decreased coordination when taking nitrazepam. The lowest effective dose of this medication should be used for the shortest possible length of time.

What other drugs could interact with this medication?

There may be an interaction between nitrazepam and any of the following:

• alcohol
• anesthetics
• anticonvulsants (e.g., carbamazepine, gabapentin, levetiracetam, phenytoin, topiramate)
• antihistamines that cause drowsiness (e.g., azelastine, chlorpheniramine, dimenhydrinate, diphenhydramine)
• antipsychotic medications (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• azole antifungal medications (e.g., fluconazole, ketoconazole)
• barbiturates (e.g., phenobarbital, secobarbital)
• other benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• brimonidine
• buprenorphine
• buspirone
• cannabis
• chloral hydrate
• cimetidine
• clonidine
• efavirenz
• entacapone
• erythromycin
• esketamine
• flibanserin
• gabapentin
• kava kava
• lemborexant
• melatonin
• metoclopramide
• methadone
• mirtazapine
• muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine)
• nabilone
• narcotic-containing medications (e.g., codeine, fentanyl, morphine, tapentadol, tramadol)
• perampanel
• pomalidomide
• pramipexole
• pregabalin
• rifampin
• ropinirole
• rotigotine
• scopolamine
• sodium oxybate
• thalidomide
• theophylline
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, imipramine)
• valerian
• yohimbine
• zolpidem
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sandoz-Nitrazepam