zolpidem tartrate

Action

Depresses CNS by binding to gamma-aminobutyric acid receptors

Availability

Oral spray: 5 mg/actuation

Tablets: 5 mg, 6.25 mg, 10 mg, 12.5 mg

Tablets (sublingual): 1.75 mg, 3.5 mg, 5 mg, 10 mg

Indications and dosages

➣ Insomnia

Adults: 10 mg P.O. (Ambien) or 12.5 mg P.O.(Ambien CR), or 10 mg (Edluar) sublingual, or 10 mg oral spray (two sprays) immediately before bedtime

➣ As-needed use for treatment of insomnia when middle-of-the-night awakening is followed by difficulty returning to sleep

Adults: 1.75 mg (Intermezzo) sublingually for women and 3.5 mg (Intermezzo) sublingually for men, taken only once per night if needed

Dosage adjustment

• Hepatic impairment

• Concurrent use of CNS depressants

• Elderly or debilitated patients

Off-label uses

• Long-term treatment of insomnia

• Insomnia related to selective serotonin reuptake inhibitors

• Postoperative sedation

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:

• pulmonary disease, hepatic or severe renal impairment

• history of psychiatric illness, suicide attempt, or substance abuse

• elderly or debilitated patients

• pregnant or breastfeeding patients

• children (safety not established).

Administration

• Don't give with or immediately after a meal.

Adverse reactions

CNS: amnesia, ataxia, confusion, euphoria, vertigo, daytime drowsiness, dizziness, drugged feeling

EENT: diplopia, abnormal vision

GI: nausea, vomiting, diarrhea, dry mouth

Other: hypersensitivity reaction, physical or psychological drug dependence, drug tolerance

Interactions

Drug-drug. Antihistamines, opioid analgesics, phenothiazines, sedative-hypnotics, tricyclic antidepressants: increased CNS depression

Ketoconazole, ritonavir: increased blood level and enhanced effects of zolpidem

Rifampin: decreased zolpidem efficacy

Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

• Monitor for physical and psychological drug dependence. Watch for drug hoarding.

• Assess for adverse reactions, including confusion, ataxia, and amnesia.

Patient teaching

• Tell patient to take immediately before bedtime (and not after a meal), because it works quickly.

• Instruct patient to place sublingual tablet under the tongue, where it will disintegrate; tell patient not to swallow tablet and not to take it with water.

• Instruct patient that oral spray pump needs to be primed initially and after not using spray for 14 days. Tell patient to fully press down on pump to make sure a full dose (5 mg) of oral spray is sprayed directly into the mouth over the tongue with each spray.

• Advise patient to take only when he is able to get a full night's sleep (7 to 8 hours) before he needs to be active again. Tell patient to use oral spray only if 4 hours of bedtime remain before planned time of waking.

• Stress that drug is meant only for short-term use (7 to 10 days).

• Tell patient rebound insomnia may occur for 1 to 2 nights after he discontinues drug.

• Inform patient that drug may cause amnesia, drowsiness, and a drugged feeling the next day.

• Caution patient to avoid driving and other hazardous activities while under drug's influence.

• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, herbs, and behaviors mentioned above.