释义 |
Ambien
Am·bi·en (ăm′bē-ən) A trademark for the tartrate salt of the drug zolpidem.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. zolpidem (zole-pi-dem) zolpidem, 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
IndicationsInsomnia with difficulties in sleep initiation (Intermezzo is indicated for insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep).ActionProduces CNS depression by binding to GABA receptors.Has no analgesic properties.Therapeutic effectsSedation and induction of sleep.PharmacokineticsAbsorption: 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)ROUTE | ONSET | PEAK* | DURATION |
---|
PO | rapid | 30 min–2 hr | 6–8 hr | PO-ER | rapid | 2–4 hr | 6–8 hr | PO-Spray | rapid | unknown | unknown | SL | rapid | unknown | unknown | *Food delays peak levels and effectsContraindications/PrecautionsContraindicated 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 EffectsCentral nervous system- daytime drowsiness (most frequent)
- dizziness (most frequent)
- abnormal thinking
- agitation
- amnesia
- behavior changes
- "drugged" feeling
- hallucinations
- sleep-driving
GastrointestinalMiscellaneous- anaphylaxis (life-threatening)
- hypersensitivity reactions
- physical dependence
- psychological dependence
- tolerance
InteractionsDrug-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.Route/DosageOral 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 / 30Extended-release tablets: 6.25 mg, 12.5 mg Cost: Generic — 6.25 mg $42.14 / 30, 12.5 mg $37.39 / 30Sublingual tablets (Edluar): 5 mg, 10 mg Cost: All strengths $235.19 / 30Sublingual tablets (Intermezzo): 1.75 mg, 3.5 mg Cost: All strengths $248.46 / 30Oral spray (Zolpimist): 5 mg/spray (60 sprays/container) Cost: $79.20 / 7.7 mLNursing implicationsNursing 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.
Ambien (ăm′bē-ən) A trademark for the tartrate salt of the drug zolpidem.Ambien® Zolpidem tartrate Neurology A hypnotic used for short-term management of insomnia See Osteoprotegerin. |