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Restoril Side Effects

Generic Name: temazepam

Note: This page contains side effects data for the generic drug temazepam. It is possible that some of the dosage forms included below may not apply to the brand name Restoril.

It is possible that some side effects of Restoril may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to temazepam: oral capsule, oral tablet

As well as its needed effects, temazepam (the active ingredient contained in Restoril) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking temazepam, check with your doctor immediately:

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
  • loss of appetite
  • loss of memory
  • nightmares
  • problems with memory
  • seeing, hearing, or feeling things that are not there
  • shakiness and unsteady walk
  • shortness of breath
  • tightness in the chest
  • trouble sleeping
  • uncontrolled eye movements
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual excitement, nervousness, restlessness, or irritability
  • weight loss
  • wheezing
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

If any of the following symptoms of overdose occur while taking temazepam, get emergency help immediately:

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
  • shortness of breath
  • sleepiness or unusual drowsiness
  • unusual tiredness or weakness

Some temazepam side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
  • Backache
  • burning eyes

For Healthcare Professionals

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]

References

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

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

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

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