Nitrazepam

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 Nitrazepam 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.

Nitrazepam 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 Nitrazepam for more than 2 to 3 weeks, consult your doctor for a re-evaluation of Nitrazepam.

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 Nitrazepam regularly for a long period of time (more than one month), do not stop taking the medication without speaking with your doctor. A gradual reduction in dose is recommended when stopping Nitrazepam to avoid withdrawal effects.

It is important to take Nitrazepam exactly as prescribed by your doctor. Do not take Nitrazepam 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). Nitrazepam 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 Nitrazepam 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause memory loss; it may cause headaches; it may cause confusion; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause a general feeling of weakness; it may cause drowsiness that lasts until the next day - use caution until you know how you will react. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

5 mg
Each white, round, flat-faced, bevelled-edged tablet, scored on one side and embossed "RHO 5" on the other side, contains nitrazepam 5 mg. Nonmedicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, and sodium croscarmellose.

10 mg
Each white round, flat-faced, bevelled-edged tablet, scored on one side and embossed "RHO 10" on the other side, contains nitrazepam BP 10 mg. Nonmedicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, and sodium croscarmellose.

Do not take nitrazepam if you:

• are allergic to nitrazepam or any ingredients of Nitrazepam
• 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

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., Chlorpheniramine, Dimenhydrinate, Diphenhydramine)
• antipsychotic medications (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Aprepitant
• azelastine
• 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
• Flibanserin
• kava kava
• melatonin
• Mirtazapine
• muscle relaxants (e.g., Cyclobenzaprine, methocarbamol, orphenadrine)
• Nabilone
• narcotic-containing medications (e.g., Codeine, Fentanyl, Morphine,
• Olopatadine
• Pomalidomide
• Pramipexole
• Pregabalin
• rifampin
• Ropinirole
• Rotigotine
• St. John's wort
• scopolamine
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Paroxetine, Sertraline)
• scopolamine
• sodium oxybate
• suvorexant
• Tapentadol
• thalidomide
• Theophylline
• tolcapone
• Tramadol
• 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 Nitrazepam. 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.

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 Nitrazepam.

HEALTH CANADA ADVISORY

October 30, 2020

Health Canada has issued new restrictions concerning the use of benzodiazepines and benzodiazepine-like prescription drugs. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Alcohol and other medications that cause drowsiness: People taking Nitrazepam 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.

Asthma and other respiratory conditions: Nitrazepam may cause increased breathing difficulty for people having an acute asthma attack, or those with COPD (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 Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Nitrazepam, and whether any special monitoring is needed.

Behavioural and mood changes: Nitrazepam 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 Nitrazepam, 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. 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: Nitrazepam can make some symptoms of depression worse. If you have depression or a history of depression, discuss with your doctor how Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Nitrazepam, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, 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 Nitrazepam, 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 Nitrazepam affects you. Drinking alcohol can increase the drowsiness effects and should be avoided.

Kidney function: If you have reduced kidney function or Kidney Disease, discuss with your doctor how Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Nitrazepam, 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 Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Nitrazepam, 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. Nitrazepam should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Nitrazepam, contact your doctor immediately.

Breast-feeding: Nitrazepam passes into breast milk. If you are a breast-feeding mother 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 Nitrazepam should be used for the shortest possible length of time.

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).

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

Your doctor may have suggested Nitrazepam 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 Nitrazepam, speak to your doctor. Do not stop taking Nitrazepam without consulting your doctor.

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