zolpidem tartrate

Also found in: Dictionary.

zolpidem tartrate

Pharmacologic class: Imidazopyridine

Therapeutic class: Sedative-hypnotic

Controlled substance schedule IV

Pregnancy risk category B


Depresses CNS by binding to gamma-aminobutyric acid receptors


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


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


• Hypersensitivity to drug


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).


• 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


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.
a drug development company, through which ECR obtained the rights to market zolpidem tartrate oral spray, 5mg per spray, in the United States and Canada.
The OpSec study found listings of zolpidem tartrate, the API for a popular prescription sleep aid, advertised in 25 kilogram drum quantities.
Ambien/Ambien CR[TM] (zolpidem tartrate) and generic zolpidem tartrate are the dominant prescription drugs totaling more than 70% of the market in 2006.
Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem tartrate administered as an oral spray versus tablets.
This growth occurred despite introduction of the generic competitor, zolpidem tartrate, which occurred during the quarter.
Verispan's Vector One[R]: National (VONA) reports zolpidem tartrate, the generic form of Ambien, has become the most prescribed drug in the sleep disorder market since its launch during the week ending April 27, 2007.
Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Zolpidem Tartrate Tablets, 5 mg and 10 mg.
Prasco Expands Authorized Generic Line with Zolpidem Tartrate Tablets 5 mg and 10 mg -