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Restoril Side Effects

Generic name: temazepam

Medically reviewed by Drugs.com. Last updated on Sep 17, 2024.

Note: This document provides detailed information about Restoril Side Effects associated with temazepam. Some dosage forms listed on this page may not apply specifically to the brand name Restoril.

Applies to temazepam: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Risks From Concomitant Use With Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal Reactions. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.The use of benzodiazepines, including temazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death.

Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes.

Before prescribing temazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.The continued use of benzodiazepines, including temazepam, may lead to clinically significant physical dependence.

The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose.

Abrupt discontinuation or rapid dosage reduction of temazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening.

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for any unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.

If your condition does not improve within 7 to 10 days, or if it becomes worse, check with your doctor.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may cause you to do things while you are still asleep that you may not remember the next morning. It is possible you could drive a car, sleepwalk, have sex, make phone calls, or prepare and eat food while you are asleep or not fully awake. Tell your doctor right away if you learn that any of these has happened.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you Stop taking temazepam (the active ingredient contained in Restoril) Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally, which may lead to falls. Even though temazepam is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, this medicine may cause double vision or other vision problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

If you develop any unusual and strange thoughts or behavior while you are using temazepam, be sure to discuss it with your doctor. Some changes that have occurred in people using this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Do not stop using this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a worsening of your condition and reduce the possibility of withdrawal symptoms, including seizures, hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

Symptoms of an overdose include: blurred vision, change in consciousness, changes in patterns and rhythms of speech, decreased or absent reflexes, difficult or trouble breathing, difficulty with coordination, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, hallucinations, irregular, fast or slow, or shallow breathing, loss of consciousness, loss of strength or energy, mood or mental changes, muscle pain or weakness, nightmares, pale or blue lips, fingernails, or skin, shakiness and unsteady walk, sleepiness or unusual drowsiness, slurred speech, sweating, trouble in speaking, trouble sleeping, unsteadiness, trembling, or other problems with muscle control or coordination, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, unusual excitement, nervousness, restlessness, or irritability, unusual tiredness or weakness, or unusual weak feeling. Call your doctor right away if you notice these symptoms.

Temazepam may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, tongue, mouth, or throat while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Restoril

Along with its needed effects, temazepam may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking temazepam:

Less common side effects

  • false or unusual sense of well-being
  • fear or nervousness
  • mood or mental changes

Rare side effects

  • chest tightness
  • difficult or labored breathing
  • fast, irregular, pounding, or racing heartbeat or pulse
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • loss of appetite
  • loss of memory
  • nightmares
  • problems with memory
  • seeing, hearing, or feeling things that are not there
  • shakiness and unsteady walk
  • uncontrolled eye movements
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual excitement, nervousness, restlessness, or irritability
  • weight loss

Incidence not known

  • muscle cramps
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • stomach cramps
  • sweating
  • trembling or shaking of the hands or feet
  • vomiting

Get emergency help immediately if any of the following symptoms of overdose occur while taking temazepam:

Symptoms of overdose

Other side effects of Restoril

Some side effects of temazepam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common side effects

  • diarrhea
  • dry mouth
  • feeling of constant movement of self or surroundings
  • headache
  • nausea
  • sensation of spinning
  • unusual dullness or feeling of sluggishness

Rare side effects

  • backache
  • burning eyes

For healthcare professionals

Applies to temazepam: oral capsule.

General adverse events

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

Nervous system

Lightheadedness, slurred speech, and unsteadiness usually occur at the start of treatment and disappear with repeated doses.[Ref]

Psychiatric

Dependence and numbed emotions usually occur at the start of treatment and disappear with repeated doses.[Ref]

Gastrointestinal

Other

Ocular

Double vision usually occurs at the start of treatment and disappears with repeated doses.[Ref]

Dermatologic

Hematologic

Hepatic

Genitourinary

Cardiovascular

Musculoskeletal

Muscle weakness usually occurs at the start of treatment and disappears with repeated doses.[Ref]

Respiratory

Respiratory depression usually occurs at the start of treatment and disappears with repeated doses.[Ref]

Metabolic

Renal

Hypersensitivity

Endocrine

See also:

References

1. (2001) "Product Information. Restoril (temazepam)." Sandoz Pharmaceuticals Corporation

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Cerner Multum, Inc. "Australian Product Information."

Frequently asked questions

Further information

Restoril side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.