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Ambien CR(trade name),
Pregnancy Category: C
ClassificationTherapeutic: sedative hypnotics
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).
Produces CNS depression by binding to GABA receptors.
Has no analgesic properties.
Sedation and induction of sleep.
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)
|PO||rapid||30 min–2 hr||6–8 hr|
|PO-ER||rapid||2–4 hr||6–8 hr|
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
- behavior changes
- "drugged" feeling
- anaphylaxis (life-threatening)
- hypersensitivity reactions
- physical dependence
- psychological dependence
Drug-Drug interactionCNS 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.
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
- 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)
- 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.
- 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.
- Relief of insomnia.
- Re-evaluate insomnia after 7–10 days of Intermezzo.
A trademark for the tartrate salt of the drug zolpidem.