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 ?
Myslee, which is made of zolpidem tartrate, can provide a natural and restful sleep to patients with insomnia.
Roth has served as a consultant to Transcept Pharmaceuticals Inc., the manufacturer of the sublingual formulation of Zolpidem tartrate. He has also received research support from and had other relationships with numerous pharmaceutical companies.
today announced they will present the latest data from two key Phase I clinical studies (Study 108 and Study 106) of investigational sleep/wake regulation agent lemborexant, including a comparison versus zolpidem tartrate extended release (zolpidem ER) and placebo on middle of the night awakening and next-morning effects, in poster presentations at the 32nd Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2018) from June 2 to 6 in Baltimore, Maryland in the United States.
According to the company, the US Food Drug Administration (FDA) had approved Intermezzo (zolpidem tartrate) sublingual tablet C-IV for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
24 November 2011 - US Transcept Pharmaceuticals Inc (NASDAQ:TSPT) said on Wednesday the US Food and Drug Administration (FDA) had approved Intermezzo (zolpidem tartrate sublingual tablet) C-IV for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Just days after the patent expired on the trade formulation of the insomnia drug Ambien, the Food and Drug Administration announced that 13 generic drug manufacturers had received approval for generic formulations of immediate-release zolpidem tartrate tablets, in 5- and 10-mg doses.
The Phase 3 pivotal study, SUNRISE 1, achieved its primary and key secondary objectives versus placebo and versus an active comparator (zolpidem tartrate extended release, "zolpidem ER") in patients 55 years and older with difficulty staying asleep through the night.
29 September 2011 - US Transcept Pharmaceuticals Inc (NASDAQ:TSPT) said on Tuesday it had resubmitted to the US Food and Drug Administration (FDA) the New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet).
The company said it is developing Intermezzo (zolpidem tartrate sublingual tablet) as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep.
"In a previous study, we found most patients were long-term users of the hypnotic zolpidem tartrate (Ambien) despite recommendations for short-term use, and many were combining it with other central nervous system depressants despite warnings," they wrote.
Zolpimist is NovaDel Pharma Inc's FDA approved oral spray formulation of zolpidem tartrate.
13 July 2011 - US Transcept Pharmaceuticals Inc (NASDAQ: TSPT) said yesterday it expects to receive a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet) on or before 14 July 2011, the PDUFA date assigned by the FDA for completion of the Intermezzo NDA review.