temazepam

temazepam

(te maz' e pam)

Apo-Temazepam (CAN), Novo-Temazepam (CAN), Restoril

Pregnancy Category X

Controlled Substance C-IV

Drug classes

Benzodiazepine

Sedative-hypnotic

Therapeutic actions

Exact mechanisms of action not understood; acts mainly at subcortical levels of the CNS, leaving the cortex relatively unaffected; main sites of action may be the limbic system and mesencephalic reticular formation; benzodiazepines potentiate the effects of GABA, an inhibitory neurotransmitter.

Indications

·        Insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, or early morning awakening

·        Recurring insomnia or poor sleeping habits

·        Acute or chronic medical situations requiring restful sleep

Contraindications and cautions

·        Contraindicated with hypersensitivity to benzodiazepines, psychoses, acute narrow-angle glaucoma, shock, coma, acute alcoholic intoxication with depression of vital signs, pregnancy (risk of congenital malformations, neonatal withdrawal syndrome), labor and delivery ("floppy infant" syndrome), lactation (infants may become lethargic and lose weight).

·        Use cautiously with impaired liver or kidney function, debilitation, depression, suicidal tendencies.

Available forms

Capsules—7.5, 15, 22.5, 30 mg

Dosages

ADULTS

15–30 mg PO before retiring.

PEDIATRIC PATIENTS

Not for use in patients < 18 yr.

GERIATRIC OR DEBILITATED PATIENTS

Initially, 15 mg PO; adjust dosage until individual response is determined. Can use 7.5 mg PO.

Pharmacokinetics

Route	Onset	Peak
Oral	Varies	1.2–1.6 hr

Metabolism: Hepatic; T_1/2: 10–20 hr

Distribution: Crosses placenta; enters breast milk

Excretion: Urine

Adverse effects

·        CNS: Transient, mild drowsiness initially; sedation, depression, lethargy, apathy, fatigue, light-headedness, disorientation, restlessness, confusion,crying, delirium, headache, slurred speech, dysarthria, stupor, rigidity, tremor, dystonia, vertigo, euphoria, nervousness, difficulty concentrating, vivid dreams, psychomotor retardation, extrapyramidal symptoms, mild paradoxical excitatory reactions during first 2 wk of treatment (especially in psychiatric patients, aggressive children, and with high dosage), visual and auditory disturbances, diplopia, nystagmus, depressed hearing, nasal congestion

·        CV: Bradycardia, tachycardia, CV collapse, hypertension and hypotension, palpitations, edema

·        Dependence: Drug dependence with withdrawal syndrome when drug is discontinued

·        Dermatologic: Urticaria, pruritus, rash, dermatitis

·        GI: Constipation, diarrhea, dry mouth, salivation, nausea, anorexia, vomiting, difficulty in swallowing, gastric disorders, elevations of blood enzymes; hepatic dysfunction, jaundice

·        GU: Incontinence, urinary retention, changes in libido, menstrual irregularities

·        Hematologic: Decreased Hct (primarily with long-term therapy), blood dyscrasias

·        Other: Hiccups, fever, diaphoresis, paresthesias, muscular disturbances, gynecomastia

Interactions

Drug-drug

·        Increased CNS depression with alcohol and other CNS depressants (eg, barbiturates, opioids)

·        Decreased sedative effects with theophylline, aminophylline, dyphylline, oxitriphylline

Nursing considerations

Assessment

·        History: Hypersensitivity to benzodiazepines; psychoses; acute narrow-angle glaucoma; shock, coma; acute alcoholic intoxication; pregnancy, lactation, impaired liver or kidney function, debilitation, depression, suicidal tendencies

·        Physical: Skin color, lesions; T; orientation, reflexes, affect, ophthalmologic examination; P, BP; R, adventitious sounds; liver evaluation, abdominal examination, bowel sounds, normal output; CBC, LFTs, renal function tests

Interventions

·        WARNING: Taper dosage gradually after long-term therapy, especially in patients with epilepsy to prevent refractory seizures.

·        Caution patient to avoid pregnancy while taking this drug; advise patient to use barrier contraceptives.

·        Prolonged therapy is generally not recommended.

Teaching points

·        Take drug exactly as prescribed.

·        During long-term therapy, do not stop taking this drug without consulting your health care provider.

·        Avoid pregnancy while taking this drug; serious fetal harm could occur. Using contraceptive measures is advised.

·        Nocturnal sleep may be disturbed for several nights after discontinuing the drug.

·        You may experience these side effects: Drowsiness, dizziness (may lessen; avoid driving or engaging in other dangerous activities); GI upset (take drug with water); depression, dreams, emotional upset, crying.

·        Report severe dizziness, weakness, drowsiness that persists, rash or skin lesions, palpitations, swelling of the extremities, visual changes, difficulty voiding.

Adverse effects in Italic are most common; those in Bold are life-threatening.