Note: This document contains side effect information about temazepam. Some dosage forms listed on this page may not apply to the brand name Restoril.
Summary
More frequent side effects include: dizziness, insomnia, lethargy, and irritability. Continue reading for a comprehensive list of adverse effects.
Applies to temazepam: oral capsules.
Warning
-
Concomitant Use with Opiates
- Concomitant use of benzodiazepines and opiates may result in profound sedation, respiratory depression, coma, and death.700 701 703 705 706 707
- Reserve concomitant use for patients in whom alternative treatment options are inadequate; use lowest effective dosages and shortest possible duration of concomitant therapy and monitor closely for respiratory depression and sedation.700 703 (See Specific Drugs under Interactions.)
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Potential for Abuse, Addiction, and Other Serious Risks
- A boxed warning has been included in the prescribing information for all benzodiazepines describing risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions.900
- Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs.900
- Assess a patient’s risk of abuse, misuse, and addiction.900 Standardized screening tools are available ([Web]).900
- To reduce risk of acute withdrawal reactions, use a gradual dose taper when reducing dosage or discontinuing benzodiazepines.900 Take precautions when benzodiazepines are used in combination with opioid medications.900
Side effects include:
Drowsiness, fatigue, lethargy, dizziness, hangover, anxiety, diarrhea, euphoria, weakness, confusion, vertigo.
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]
