zolpidem tartrate


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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.

References in periodicals archive ?
the manufacturer of the sublingual formulation of zolpidem tartrate.
The search also uncovered 12 Codeine Phosphate pills, a pack of 14 Zolpidem Tartrate and 14 Kapake capsules - all pain killers.
Persons Reporting Prescriptions for 10 Leading Psychiatric Drugs (a) Drug Name Mechanism Rank (Brand Name) of Action 1 Sertraline hydrochlolride SSRI (Zoloft) antidepressant 2 Citalopram hydrobromide SSRI (Celexa) antidepressant 3 Alprazolam (Xanax) Benzodiazepine 4 Zolpidem tartrate (Ambien) Hypnotic 5 Fluoxetine hydrochloride SSRI (Prozac) antidepressant 6 Trazodone hydrochloride SARI (Desyrel) antidepressant 7 Clonazepam (Klonopin) Benzodiazepine 8 Lorazepam (Ativan) Benzodiazepine 9 Escitalopram oxalate SSRI (Lexapro) antidepressant 10 Duloxetine hydrochloride SNRI (Cymbalta) antidepressant Reported Use, Prescriptions per Rank No.
5/30); Blisovi Fe 1/20 tablets (Loestrin Fe 1/20); and zolpidem tartrate sublingual, CIV tablets (Intermezzo).
Tenders are invited for zolpidem tartrate tab/lithium carbonate tab/tablet opipramol dihydrochloride tab/opipramol dihydrochloride tab
Zolpimist is NovaDel Pharma Inc's FDA approved oral spray formulation of zolpidem tartrate.
141 Zolpidem Tartrate Torrent 13668000801 3,598,626
Speciality pharmaceutical company ECR Pharmaceuticals Co Inc, a subsidiary of Hi-Tech Pharmacal Co Inc (NASDAQ:HITK), reported on Friday the launch of Zolpimist Oral Spray, a novel delivery system of the most widely prescribed sleep aid in the US, zolpidem tartrate.
M2 PHARMA-October 19, 2010-Actavis gets FDA approval to market Zolpidem Tartrate Extended-Release Tablets(C)2010 M2 COMMUNICATIONS