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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 gamma-
aminobutyrate (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
Available forms
Capsules—7.5, 15, 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.
Pharmacokinetics
Route Onset Peak
Oral Varies 1.2–1.6 hr
Metabolism: Hepatic; T1/2: 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
exam; P, BP; R, adventitious sounds; liver evaluation, abdominal exam, bowel
sounds, normal output; CBC, liver and renal function tests
Interventions
• Taper dosage gradually after long-term therapy, especially in patients with
epilepsy.
• 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
barrier contraceptives is advised.
• Nocturnal sleep may be disturbed for several nights after discontinuing the drug.
• These side effects may occur: 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.