Skip to Content

Restoril Side Effects

Generic Name: temazepam

Note: This document contains side effect information about temazepam. Some of the dosage forms listed on this page may not apply to the brand name Restoril.

In Summary

More frequent side effects include: dizziness, insomnia, lethargy, and irritability. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to temazepam: oral capsule, oral tablet

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

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

Rare

  • 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, sex organs
  • loss of appetite
  • loss of memory
  • nightmares
  • problems with memory
  • seeing, hearing, or feeling things that are not there
  • shakiness and unsteady walk
  • tightness in the chest
  • 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

  • Blurred vision
  • change in consciousness
  • confusion
  • decreased or absent reflexes
  • difficult or troubled breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • irregular, fast, slow, or shallow breathing
  • loss of consciousness
  • pale or blue lips, fingernails, or skin
  • sleepiness or unusual drowsiness
  • unusual tiredness or weakness

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

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

Rare

For Healthcare Professionals

Applies to temazepam: oral capsule

General

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]

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]

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

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

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

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Restoril (temazepam)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Hide