Temazepam

Poor sleep (insomnia) is fairly common but it does not usually last for long. If you have problems sleeping, it may mean that you have difficulty getting off to sleep, or you may wake up for long periods during the night, or you may wake up too early in the morning. 'Sleeping tablets' like temazepam are considered a last resort, but are sometimes prescribed for a short period of time to help with a particularly bad spell of insomnia.

Temazepam works by affecting the way certain natural brain chemicals (neurotransmitters) transmit messages. This has a calming effect which helps you to sleep. It works well in the short term, with one week's treatment normally being sufficient, although up to three weeks of treatment are sometimes required. If you take it for longer, the medicine can lose its effect (you may become tolerant to the effect) and you may also become dependent on it (addicted to it).

Temazepam is also given as a once-only dose to reduce feelings of anxiety before some investigations and minor surgery. It is given an hour or two before the procedure.

• Try to keep any appointments with your doctor. This is so your doctor can check how you are feeling.
• The effects of temazepam can last into the following day; please be aware that it is likely to impair your judgement and reactions, and so affect your ability to drive. It is an offence to drive while your reactions are impaired, so do not drive until you know how you react, especially when you first start treatment. Even if your driving ability is not impaired, should you drive, you are advised to carry with you some evidence that the medicine has been prescribed for you - a repeat prescription form or a patient information leaflet from the pack is generally considered suitable.
• Do not drink alcohol while you are on temazepam. It will increase the risk of sedative side-effects.
• If you are due to have an operation or any dental treatment, please tell the person carrying out the treatment that you are taking a benzodiazepine. This is because temazepam increases the effects of some anaesthetics.
• Your doctor may recommend that you reduce your dose gradually when it is time to stop taking it. This is to reduce the risk of you experiencing withdrawal effects. Follow carefully any instructions your doctor gives to you.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Temazepam is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

What Are the Typical Dosages for Temazepam (Restoril)?

Temazepam capsules are taken orally and come in dosages of 7.5 milligrams (mg), 15 mg, 22.5 mg, and 30 mg. While the recommended adult dose is generally 15 mg about 30 minutes before going to bed, 7.5 mg may be sufficient for some people, and others may need 30 mg.

For transient insomnia, a 7.5 mg dose may be sufficient, and it's recommended that elderly or debilitated people begin with 7.5 mg until individual responses are determined.

What Happens If I Take Too Much Temazepam (Restoril) and Overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of temazepam can be fatal, especially if taken with alcohol.

Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, slurred speech, tremors, a slow heartbeat, shallow breathing, feeling lightheaded, fainting, seizure (black-out or convulsions), and coma.

What Happens If I Miss a Dose of Temazepam (Restoril) or Don't Take It as Prescribed?

Since temazepam is meant to be taken only as needed, you are not likely to be on a dosing schedule. Missing a dose doesn't typically cause any problems. Take temazepam only when you have time to sleep 7 to 8 hours.

The most common side effects of temazepam are:

• drowsiness
• headache
• tiredness
• nervousness
• dizziness
• nausea
• “hangover” feeling the day after taking temazepam
• You may still feel drowsy the next day after taking temazepam. Do not drive or do other dangerous activities after taking temazepam until you feel fully awake.
• You may have withdrawal symptoms if you stop taking temazepam suddenly. Withdrawal symptoms can be serious and include seizures. Mild withdrawal symptoms include a depressed mood and trouble sleeping. Talk to your doctor to check if you need to stop temazepam slowly.

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Possible serious side effects of temazepam include:

• getting out of bed while not being fully awake and doing an activity that you do not know you are doing. After taking temazepam, 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 not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with temazepam. Reported activities include:
  • driving a car (“sleep-driving”)
  • making and eating food
  • talking on the phone
  • having sex
  • sleep-walking

  Call your doctor right away if you find out that you have done any of the above activities after taking temazepam.

• abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts.
• memory loss
• anxiety
• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking temazepam.

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using temazepam.

Important:

1. Take temazepam exactly as prescribed.
   • Do not take more temazepam than prescribed.
   • Take temazepam right before you get in bed, not sooner.
2. Do not take temazepam if you:
   • drink alcohol
   • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take temazepam with your other medicines.
   • cannot get a full night's sleep.

Do not take temazepam if you are pregnant or planning to become pregnant. Temazepam may cause birth defects or harm a fetus (unborn baby).

• Take temazepam exactly as prescribed. Do not take more temazepam than prescribed for you.
• Take temazepam right before you get into bed.
• Do not take temazepam unless you are able to get a full night's sleep before you must be active again.
• Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems.
• If you take too much temazepam or overdose, call your doctor or poison control center right away, or get emergency treatment.

If you take too much temazepam or overdose, call your doctor or poison control center right away, or get emergency treatment.

• Store temazepam at room temperature, 68° to 77°F (20° to 25°C).
• Keep temazepam and all medicines out of reach of children.

Temazepam is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep temazepam in a safe place to prevent misuse and abuse. Selling or giving away temazepam may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• Provide patient with a copy of manufacturer’s patient information.a

• Importance of taking only as prescribed; do not increase dosage or duration of therapy unless otherwise instructed by a clinician.a

• Importance of informing clinicians of any behavioral or mental changes, memory impairment, tolerance, or dependence/withdrawal symptoms.a

• Importance of taking only when able to get a full night’s sleep (i.e., 7–8 hours) before being active again.a

• Potential for drug to impair mental alertness or physical coordination; use caution when operating machinery or performing hazardous tasks until effects on individual are known.a

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescriptions and OTC drugs, and of concomitant illnesses, particularly depression.a

• Importance of not consuming alcoholic beverages.a

• Risk of rebound insomnia for 1 or 2 nights after discontinuance.a

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.b

• Importance of informing patients of other important precautionary information. (See Cautions.)a

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For temazepam, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to temazepam or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of temazepam in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of temazepam in the elderly. However, elderly patients are more likely to have unwanted effects (eg, severe drowsiness, dizziness, confusion, clumsiness, or unsteadiness) and age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving temazepam.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking temazepam, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using temazepam with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Flumazenil

Using temazepam with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Amobarbital
• Bromazepam
• Bromopride
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Carbinoxamine
• Carisoprodol
• Chloral Hydrate
• Chlorzoxazone
• Codeine
• Dantrolene
• Dihydrocodeine
• Doxylamine
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Fospropofol
• Hydrocodone
• Hydromorphone
• Levorphanol
• Meclizine
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Primidone
• Propofol
• Secobarbital
• Sodium Oxybate
• Tapentadol
• Thiopental
• Tramadol
• Zolpidem

Using temazepam with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Rifapentine
• St John's Wort
• Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using temazepam with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use temazepam, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of temazepam. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol or abuse, or history of or
• Breathing problems or lung disease or
• Depression, history of or
• Drug abuse or dependence, or history of or
• Mental health problems, history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• If you have an allergy to temazepam or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are pregnant or may be pregnant. Do not take temazepam if you are pregnant.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take temazepam with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may be habit-forming with long-term use.
• When sleep drugs are used nightly for more than a few weeks, they may not work as well to help sleep problems. This is known as tolerance. Only use sleep drugs for a short time. If sleep problems last, call the doctor.
• If you have been taking temazepam for more than 10 days, talk with your doctor before stopping. You may want to slowly stop this medicine.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how temazepam affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Avoid alcohol or other drugs and natural products that slow your actions.
• Use birth control that you can trust to prevent pregnancy while taking this medicine.
• If you are 65 or older, use temazepam with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Temazepam improved sleep parameters in clinical studies. Residual medication effects (“hangover”) were essentially absent. Early morning awakening, a particular problem in the geriatric patient, was significantly reduced.
Patients with chronic insomnia were evaluated in 2 week, placebo controlled sleep laboratory studies with Temazepam at doses of 7.5 mg, 15 mg, and 30 mg, given 30 minutes prior to bedtime. There was a linear dose-response improvement in total sleep time and sleep latency, with significant drug-placebo differences at 2 weeks occurring only for total sleep time at the 2 higher doses, and for sleep latency only at the highest dose.
In these sleep laboratory studies, REM sleep was essentially unchanged and slow wave sleep was decreased. No measurable effects on daytime alertness or performance occurred following Temazepam treatment or during the withdrawal period, even though a transient sleep disturbance in some sleep parameters was observed following withdrawal of the higher doses. There was no evidence of tolerance development in the sleep laboratory parameters when patients were given Temazepam nightly for at least 2 weeks.
In addition, normal subjects with transient insomnia associated with first night adaptation to the sleep laboratory were evaluated in 24 hour, placebo controlled sleep laboratory studies with Temazepam at doses of 7.5 mg, 15 mg, and 30 mg, given 30 minutes prior to bedtime. There was a linear dose-response improvement in total sleep time, sleep latency and number of awakenings, with significant drug-placebo differences occurring for sleep latency at all doses, for total sleep time at the 2 higher doses and for number of awakenings only at the 30 mg dose.

If the patient is conscious, vomiting should be induced mechanically or with emetics. Gastric lavage should be employed utilizing concurrently a cuffed endotracheal tube if the patient is unconscious to prevent aspiration and pulmonary complications. Maintenance of adequate pulmonary ventilation is essential. The use of pressor agents intravenously may be necessary to combat hypotension. Fluids should be administered intravenously to encourage diuresis. The value of dialysis has not been determined. If excitation occurs, barbiturates should not be used. It should be borne in mind that multiple agents may have been ingested. Flumazenil (Romazicon® )*, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.
Up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk References®**.

Temazepam Capsules, USP CIV

7.5 mg

30 Capsules

Insomnia: Oral: Usual dose: 15 to 30 mg at bedtime; some patients may respond to 7.5 mg in transient insomnia

Insomnia: Oral: Initial: 7.5 mg in elderly or debilitated patients at bedtime.

1% to 10%:

Central nervous system: Drowsiness (9%), dizziness (5%), lethargy (5%), hangover effect (3%), euphoria (2%), anxiety, confusion, dysarthria, fatigue, headache, vertigo

Dermatologic: Diaphoresis, skin rash

Endocrine & metabolic: Decreased libido

Gastrointestinal: Diarrhea (2%)

Neuromuscular & skeletal: Weakness

Ophthalmic: Blurred vision

<1% (Limited to important or life-threatening): Abnormal behavior, aggressive behavior, amnesia, anaphylaxis, angioedema, ataxia, depersonalization, drug dependence, hallucination, hyperhidrosis, nausea, nystagmus, paradoxical reactions, sleep disorder (sleep-driving, cooking or eating food, making phone calls)

Do not use temazepam if you are pregnant. This medicine can cause birth defects or life-threatening withdrawal symptoms in a newborn.

Temazepam may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.Misuse of habit-forming medicine can cause addiction, overdose, or death.

Temazepam may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Take this medication only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking temazepam and talk with your doctor about another treatment for your sleep disorder.

Take temazepam exactly as it was prescribed for you. Follow all directions on your prescription label. Never use in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in treating your symptoms.

Temazepam may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

You should not even share this medicine with another person who has the same symptoms you have.

Misuse of habit-forming medicine can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Take temazepam only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Do not take this medicine unless you are able to get a full night's sleep before you must be active again.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using temazepam.

Temazepam should be used for only a short time to treat insomnia. Call your doctor if your symptoms do not improve after 7 to 10 nights of treatment, or if this medicine seems to stop working as well in helping you fall asleep and stay asleep.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Your insomnia symptoms may also return when you stop using the medicine. Ask your doctor how to safely stop taking temazepam.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Temazepam is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Applies to temazepam: oral capsule

Nervous system

Common (1% to 10%): Drowsiness, headache, nervousness, dizziness, vertigo
Uncommon (0.1% to 1%): Ataxia, equilibrium loss, tremor
Rare (less than 0.1%): Amnesia
Frequency not reported: Sedation, reduced alertness, confusion, disorientation, muzziness, sciatica, faintness, loss of taste, extrapyramidal symptoms, dysarthria/slurred speech, convulsions/seizures, disinhibition, coma, unsteadiness[Ref]

Other

Common (1% to 10%): Fatigue, lethargy, hangover, weakness,
Frequency not reported: Asthenia, hypothermia[Ref]

Psychiatric

Common (1% to 10%): Anxiety, depression, euphoria, nightmare
Uncommon (0.1% to 1%): Increased dreaming
Rare (less than 0.1%): Hallucinations, paradoxical reactions (including overstimulation, agitation, acute rage)
Frequency not reported: Numbed emotions, unmasking of depression, vivid dreams, suicidal ideation/attempt[Ref]

Hepatic

Frequency not reported: Elevated serum alkaline phosphatase, elevated AST, elevated bilirubin, jaundice[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, dry mouth, diarrhea, abdominal discomfort
Uncommon (0.1% to 1%): Vomiting
Frequency not reported: Gastrointestinal upset, constipation[Ref]

Hematologic

Frequency not reported: Thrombocytopenia, agranulocytosis, pancytopenia[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions, anaphylactic reactions, anaphylactoid reactions[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations
Frequency not reported: Tachycardia, hypotension, lowering in blood pressure[Ref]

Dermatologic

Uncommon (0.1% to 1%): Hyperhidrosis
Frequency not reported: Macular rash, pruritus, alopecia[Ref]

Endocrine

Frequency not reported: SIADH (syndrome of inappropriate antidiuretic hormone) secretion, hyponatremia[Ref]

General

The most commonly reported side effects were drowsiness, headache, fatigue, and nervousness.[Ref]

Genitourinary

Frequency not reported: Change in libido, impotence, decreased orgasm[Ref]

Immunologic

Frequency not reported: Leukocytosis[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Backache
Frequency not reported: Muscle weakness, leg cramps, weakness[Ref]

Ocular

Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Burning eyes
Rare (less than 0.1%): Horizontal nystagmus
Frequency not reported: Visual disturbance (including diplopia)[Ref]

Renal

Frequency not reported: Elevated BUN, proteinuria[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea
Frequency not reported: Respiratory depression, breathlessness, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease[Ref]

Some side effects of temazepam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

• Temazepam takes approximately 30 minutes to start working, with peak effects seen at three-quarters to one hour. Effects last approximately seven to eight hours.
• Do not take temazepam if you do not intend to stay asleep or in bed for at least eight hours. Otherwise, you may find yourself still under the effects of the drug, which may affect your ability to concentrate or drive.

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