Product Details

 Action Mechanism is unknown but may involve subunit modulation of the aminobutyrate activase (GABA) receptor chloride channel macromolecular complex.

 Indications Short-term treatment of insomnia.

 Contraindications Standard considerations.

 Route/Dosage

ADULTS: PO 10 mg immediately before bedtime. ELDERLY, DEBILITATED, OR HEPATIC INSUFFICIENCY PATIENTS: An initial 5 mg dose is recommended. Maximum dose: Do not exceed 10 mg.

 Interactions

Food: Reduces absorption of zolpidem. Ritonavir: Possible severe sedation and respiratory depression.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Palpitations. CNS: Amnesia; daytime drowsiness; dizziness; headache; lethargy; “drugged feelings”, lightheadedness; depression; abnormal dreams; ataxia; confusion; euphoria; insomnia; vertigo. EENT: Sinusitis; pharyngitis; diplopia, abnormal vision. GI: Diarrhea; constipation; dry mouth. OTHER: Allergy; back pain; flu-like symptoms; chest pain.

 Precautions

Pregnancy: Category B. Lactation: Excreted in breast milk. Children: Safety and efficacy not established. Elderly/debilitated patients: Closely monitor these patients. Recommended dosage is 5 mg. Duration of therapy: Generally limit to 7 to 10 days, re-evaluate patient if to be taken for > 2 to 3 weeks. Abrupt discontinuation: Has been associated with withdrawal symptoms similar to those associated with other CNS depressant drugs. Hepatic function impairment: Dosage modification may be necessary. Abuse/Dependence: Use with caution in patients with history of drug or alcohol abuse, depression, or suicidal tendencies. Respiratory depression: Use with caution in patients with compromised respiratory function.

 Administration/Storage

• Available only in PO tablet form.
• Administer immediately before bedtime on an empty stomach.
• Store at room temperature (19° to 30°C; 66° to 86°F).
• Keep in tightly sealed, child-proof container.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hepatic impairment, debilitated status, and respiratory status.
• Ensure that side rails are raised after administration.
• Assist patient with ambulation after administration of drug.
• Assess sleep patterns prior to and during therapy.
• Assess for the development of abnormal thinking or behavior changes during therapy.

 Patient/Family Education

• Advise patient to take immediately before going to bed. Advise patient to take on an empty stomach.
• Warn patient to never stop taking medication suddenly; withdrawal symptoms may develop.
• Instruct patient to avoid alcohol and other CNS depressants while taking drug.
• Caution patients to avoid driving or other tasks requiring alertness, coordination, or physical dexterity due to drowsiness that may occur.
• Instruct patient to take medication exactly as directed; do not increase dosage without health care provider approval.
• Emphasize the importance of follow-up appointments to monitor progress of therapy.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
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