Medical term:

Ambien


zolpidem tartrate

Ambien, Ambien CR, Edluar, Intermezzo, Stilnoct (UK), Zolpimist

Pharmacologic class: Imidazopyridine

Therapeutic class: Sedative-hypnotic

Controlled substance schedule IV

Pregnancy risk category B

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.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved

zolpidem

(zole-pi-dem) ,

Ambien

(trade name),

Ambien CR

(trade name),

Edluar

(trade name),

Intermezzo

(trade name),

Sublinox

(trade name),

Zolpimist

(trade name)

Classification

Therapeutic: sedative hypnotics
Pregnancy Category: C

Indications

Insomnia with difficulties in sleep initiation (Intermezzo is indicated for insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep).

Action

Produces CNS depression by binding to GABA receptors.
Has no analgesic properties.

Therapeutic effects

Sedation and induction of sleep.

Pharmacokinetics

Absorption: Rapidly absorbed following oral administration. Controlled-release formulation releases 10 mg immediately, then another 2.5 mg later.
Distribution: Minimal amounts enter breast milk; remainder of distribution not known.
Metabolism and Excretion: Converted to inactive metabolites, which are excreted by the kidneys; clearance of Intermezzo lower in women than in men.
Half-life: 2.5–3 hr (↑ in geriatric patients and patients with hepatic impairment).

Time/action profile (sedation)

ROUTEONSETPEAK*DURATION
POrapid30 min–2 hr6–8 hr
PO-ERrapid2–4 hr6–8 hr
PO-Sprayrapidunknownunknown
SLrapidunknownunknown
*Food delays peak levels and effects

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Sleep apnea.
Use Cautiously in: History of previous psychiatric illness, suicide attempt, drug or alcohol abuse;Hepatic impairment (initial dose ↓ recommended);Pulmonary disease;Sleep apneaMyasthenia gravis Geriatric: Initial dose ↓ recommended; Obstetric / Lactation / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • daytime drowsiness (most frequent)
  • dizziness (most frequent)
  • abnormal thinking
  • agitation
  • amnesia
  • behavior changes
  • "drugged" feeling
  • hallucinations
  • sleep-driving

Gastrointestinal

  • diarrhea
  • nausea
  • vomiting

Miscellaneous

  • anaphylaxis (life-threatening)
  • hypersensitivity reactions
  • physical dependence
  • psychological dependence
  • tolerance

Interactions

Drug-Drug interaction

CNS depression may ↑ with sedatives/hypnotics, alcohol, phenothiazines, tricyclicantidepressants, opioid analgesics, or antihistamines.Concomitant use of kava-kava, valerian, or chamomile can ↑ CNS depression.Food ↓ and delays absorption.

Route/Dosage

Oral Sublingual (Adults) Tablets, spray, or SL tablets (Edluar)—5 mg (for women) and 5–10 mg (for men) at bedtime; may ↑ to 10 mg at bedtime if 5–mg dose not effective; SL tablets (Intermezzo)—1.75 mg (for women) or 3.5 mg (for men) once upon awakening in the middle-of-the-night; Extended-release tablets—6.25 mg (for women) and 6.25–12.5 mg (for men) at bedtime; may ↑ to 12.5 mg at bedtime if 6.25–mg dose not effective.
Oral Sublingual (Geriatric Patients, Debilitated Patients, or Patients with Hepatic Impairment) Tablets, spray or SL tablets (Edluar)—Do not exceed dose of 5 mg at bedtime; Extended-release tablets—Do not exceed dose of 6.25 mg at bedtime.
Sublingual (Geriatric Patients, Patients taking concomitant CNS depressants, or Patients with Hepatic Impairment) SL tablets (Intermezzo)—Do not exceed dose of 1.75 mg at bedtime (in either men or women)

Availability (generic available)

Tablets: 5 mg, 10 mg Cost: Generic — 5 mg $7.81 / 30
Extended-release tablets: 6.25 mg, 12.5 mg Cost: Generic — 6.25 mg $42.14 / 30, 12.5 mg $37.39 / 30
Sublingual tablets (Edluar): 5 mg, 10 mg Cost: All strengths $235.19 / 30
Sublingual tablets (Intermezzo): 1.75 mg, 3.5 mg Cost: All strengths $248.46 / 30
Oral spray (Zolpimist): 5 mg/spray (60 sprays/container) Cost: $79.20 / 7.7 mL

Nursing implications

Nursing assessment

  • Assess mental status, sleep patterns, and potential for abuse prior to administration. Prolonged use of >7–10 days may lead to physical and psychological dependence. Limit amount of drug available to the patient.
  • Assess alertness at time of peak effect. Notify health care professional if desired sedation does not occur.
  • Assess patient for pain. Medicate as needed. Untreated pain decreases sedative effects.

Potential Nursing Diagnoses

 (Indications)
Risk for injury (Side Effects)

Implementation

  • Before administering, reduce external stimuli and provide comfort measures to increase effectiveness of medication.
    • Protect patient from injury. Raise bed side rails. Assist with ambulation. Remove patient’s cigarettes.
    • Use lowest effective dose.
  • Oral: Tablets should be swallowed whole with full glass of water. For faster onset of sleep, do not administer with or immediately after a meal.
    • Swallow extended-release tablets whole; do not crush, break, or chew.
  • Sublingual: To open the blister pack, separate the individual blisters at the perforations. Peel off top layer of paper and push tablet through foil. Place the tablet under the tongue, allow to disintegrate; do not swallow or take with water.
    • Intermezzo: Only take if at least 4 hr left prior to time to awakening.
  • Oral Spray: Do not take with or immediately after a meal. Spray is a clear, colorless, and cherry-flavor solution.

Patient/Family Teaching

  • Instruct patient to take zolpidem as directed. Advise patient not to take zolpidem unless able to stay in bed a full night (7–8 hours) before being active again. Do not take more than the amount prescribed because of the habit-forming potential. Not recommended for use longer than 7–10 days. If used for 2 wk or longer, abrupt withdrawal may result in fatigue, nausea, flushing, light-headedness, uncontrolled crying, vomiting, GI upset, panic attack, or nervousness. Instruct patient to read Patient Information for correct product before taking and with each Rx refill, changes may occur.
  • Because of rapid onset, advise patient to go to bed immediately after taking zolpidem.
  • May cause daytime drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to this medication is known.
  • Caution patient that complex sleep-related behaviors (sleep-driving) may occur while asleep.
  • Advise patient to notify health care professional immediately if signs of anaphylaxis (swelling of the tongue or throat, trouble breathing, and nausea and vomiting) occur.
  • Caution patient to avoid concurrent use of alcohol or other CNS depressants.
  • Oral Spray: To prime, patients should be told to point the black spray opening away from their face and other people and spray 5 times. For administration, hold container upright with the black spray opening pointed directly into the mouth. Press down fully on pump to make sure a full dose (5 mg) is sprayed directly into mouth over tongue. For 10-mg dose, a second spray should be administered. If not used for 14 days, re-prime with 1 spray.

Evaluation/Desired Outcomes

  • Relief of insomnia.
    • Re-evaluate insomnia after 7–10 days of Intermezzo.
Drug Guide, © 2015 Farlex and Partners

Ambien

(ăm′bē-ən)
A trademark for the tartrate salt of the drug zolpidem.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.

Ambien®

Zolpidem tartrate Neurology A hypnotic used for short-term management of insomnia See Osteoprotegerin.
McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc.


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