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.

Serious side effects of Restoril

Along with its needed effects, temazepam (the active ingredient contained in Restoril) 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

• agitation
• blurred vision
• change in consciousness
• changes in patterns and rhythms of speech
• confusion
• decreased or absent reflexes
• difficult or trouble breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• irregular, fast, slow, or shallow breathing
• loss of consciousness
• loss of strength or energy
• nightmares
• pale or blue lips, fingernails, or skin
• shakiness and unsteady walk
• sleepiness or unusual drowsiness
• slurred speech
• trouble speaking
• 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

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

• Common (1% to 10%): Dizziness, drowsiness, hangover, headache, lethargy, sedation, vertigo
• Uncommon (0.1% to 1%): Ataxia, equilibrium loss, faintness, muzziness, sciatica, taste loss, tremor
• Rare (0.01% to 0.1%): Dysarthria
• Frequency not reported: Amnesia, anterograde amnesia, coma, convulsions, daytime drowsiness, epileptic seizures, extrapyramidal symptoms, extremity tingling, horizontal nystagmus, hypersensitivity to light/noise/physical contact, impaired concentration, lightheadedness, numbness, oversedation, perceptual disturbances, reduced alertness, seizures, slurred speech, unsteadiness^[Ref]

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

Psychiatric

• Common (1% to 10%): Anxiety, confusion, depression, euphoria, nervousness, nightmares
• Uncommon (0.1% to 1%): Decreased orgasm, disorientation, increased dreaming, irritability, libido changes, unmasking of depression, vivid dreams
• Rare (0.01% to 0.1%): Restless sleep
• Frequency not reported: Abuse, aggressiveness/aggression, agitation, broken sleep (with vivid dreams), confusional states, delusion, depersonalization, dependence, derealization, disinhibition, excitement, extreme anxiety, hallucinations, hostility, inappropriate behavior, insomnia, mood changes, numbed emotions, other adverse behavioral effects, overstimulation, physical dependence, psychological dependence, psychoses, psychotic manifestations, rage, rebound insomnia, restlessness, sexual arousal, sleep disturbance, stimulation, suicidal attempt, suicidal ideation, tension, withdrawal effects/symptoms^[Ref]

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

Gastrointestinal

• Common (1% to 10%): Abdominal discomfort, diarrhea, dry mouth, nausea
• Uncommon (0.1% to 1%): Gastrointestinal upset, vomiting
• Rare (0.01% to 0.1%): Salivation changes
• Frequency not reported: Abdominal cramps, constipation, gastrointestinal disturbances^[Ref]

Other

• Common (1% to 10%): Fatigue, weakness
• Uncommon (0.1% to 1%): Asthenia
• Frequency not reported: Falls, hyperacusis, hypothermia, paradoxical reactions, rebound phenomenon, tinnitus^[Ref]

Ocular

• Common (1% to 10%): Blurred vision
• Uncommon (0.1% to 1%): Burning eyes
• Rare (0.01% to 0.1%): Visual disturbances
• Frequency not reported: Diplopia/double vision, photophobia^[Ref]

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

Dermatologic

• Uncommon (0.1% to 1%): Allergic skin reactions, hyperhidrosis, macular rash, pruritus
• Rare (0.01% to 0.1%): Skin reactions
• Frequency not reported: Alopecia, sweating^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Increased neutrophils, leukocytosis
• Rare (0.01% to 0.1%): Blood disorders, blood dyscrasias
• Frequency not reported: Agranulocytosis, pancytopenia, thrombocytopenia^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Increased AST, increased bilirubin
• Rare (0.01% to 0.1%): Abnormal liver function, jaundice
• Frequency not reported: Increased liver enzymes^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Impotence, proteinuria
• Rare (0.01% to 0.1%): Incontinence, urinary retention^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Palpitations, tachycardia
• Rare (0.01% to 0.1%): Hypotension
• Frequency not reported: Lowering in blood pressure, mild systolic hypertension, orthostatic hypotension^[Ref]

Musculoskeletal

• Uncommon (0.1% to 1%): Backache, leg cramps
• Rare (0.01% to 0.1%): Impaired muscular function
• Frequency not reported: Muscle pain, muscle weakness^[Ref]

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

Respiratory

• Uncommon (0.1% to 1%): Breathlessness, dyspnea
• Frequency not reported: Apnea, respiratory depression, worsening of obstructive pulmonary disease, worsening of sleep apnea^[Ref]

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

Metabolic

• Uncommon (0.1% to 1%): Anorexia, increased serum alkaline phosphatase
• Frequency not reported: Hyponatremia, loss of appetite^[Ref]

Renal

• Uncommon (0.1% to 1%): Increased blood urea nitrogen^[Ref]

Hypersensitivity

• Rare (0.01% to 0.1%): Fatal anaphylaxis
• Frequency not reported: Hypersensitivity reactions, severe anaphylactic reaction, severe anaphylactoid reaction^[Ref]

Endocrine

• Frequency not reported: Syndrome of inappropriate antidiuretic hormone secretion (SIADH)^[Ref]

Frequently asked questions

• What are the strongest sleeping pills?

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.

Medical Disclaimer