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 ?
(Ambien and Ambien CR are also available as generics.) "We have learned rather recently that women appear to be more susceptible to the risk of next morning impairment, because they eliminate zolpidem more slowly from their bodies than men," Dr.
Zolpidem Tartrate Extended-Release Tablets 6.25mg, the generic equivalent of Ambien CR 6.25mg by sanofi-sventis, had US sales of approximately USD129m (EUR92.7m) for the 12 months ending 30 June 2010, according to IMS Health.
We see revenues for both companies increasing dramatically over the next few years, even though indiplon will most likely be the fourth new entrant into the insomnia space after the launches of Sepracor's Lunesta, Takeda Pharmaceutical's Rozerem, and Sanofi-Aventis Group's Ambien CR in 2005.
In addition to the novel drug Rozerem (ramelteon), the Food and Drug Administration approved the hypnotic drugs Lunesta (eszopiclone) and a new, slow-release formulation of zolpidem called Ambien CR. At least one other hypnotic compound, indiplon, could appear in pharmacies next year.
Evidence of this association was so compelling, the Food and Drug Administration recently announced that it is requiring manufacturers of Ambien, Ambien CR, Zolpimist, and Edluar, sleep aids that contain zolpidem, to lower recommended doses.
* extended-release zolpidem (Ambien CR), 1.5 to 2.4 hours (although the active drug is released from its matrix over a longer duration)
The company also markets the controlled-release formulation, as Ambien CR, which was approved in 2005.
With offices in New York, San Francisco, Los Angeles, Seattle, Dallas, and Indianapolis, Optimedia works with some amazing brands such as T-Mobile, L'Oreal, Diesel, Armani, Garnier, Maybelline NY, Cartier, Kitchen-Aid, Ambien CR, Denny's, Citizen Watches and Mont Blanc.
There is an increasing number of hypnotics--eszopiclone (Lunesta), ramelteon (Rozerem), and zolpidem extended release (Ambien CR) were added last year--to choose from, but none has been approved specifically for insomnia of any psychiatric disorder, Dr.
Eszopiclone and extended-release zolpidem (Ambien CR) have no time restrictions on their use.
and Synthon Holding BV illegally failed to inform the agency about patent agreements on the insomnia drug Ambien CR. But the commission's staff advised the FTC not to impose penalties, because the lack of a filing didn't harm rivals or consumers.
In the last year of its patent-protected existence Ambien CR, an extended release form of Ambien, was advertised heavily.