Zolpidem tartrate sublingual 1.75 mg/1
Zolpidem tartrate sublingual · TABLET · Par Health USA, LLC
Zolpidem tartrate sublingual is a prescription medication in tablet form that dissolves under the tongue and is used to help people who have difficulty falling asleep. It works by slowing brain activity to allow for sleep.
Key Facts
- Brand Name
- Zolpidem tartrate sublingual
- Generic Name
- Zolpidem tartrate sublingual
- NDC Code (Product)
49884-898- Manufacturer
- Par Health USA, LLC
- Strength
- 1.75 mg/1
- Dosage Form
- TABLET
- Route
- SUBLINGUAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA204229
- Marketing Start
- 09/11/2017
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Purdue Pharma L.P.
Failed dissolution specifications
Purdue Pharma L.P.
Failed Dissolution Specifications
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Zolpidem tartrate sublingual tablets are indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitations of Us e: Zolpidem tartrate sublingual tablets are not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. Zolpidem tartrate sublingual tablets are a GABA A agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep Limitation of Use : Not indicated for the treatment of middle-of-the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Take only if 4 hours of bedtime remain before the planned time of waking (2.1, 5.1) Zolpidem tartrate sublingual tablets should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole. (2.1) The effect of zolpidem tartrate sublingual tablets may be slowed if taken with or immediately after a meal (2.1) Recommended dose is 1.75 mg for women and 3.5 mg for men, taken only once per night if needed (2.2) Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate sublingual tablets (2.3) Co-administration with CNS depressants: Recommended dose is 1.75 mg for men and women (2.3) Geriatric patients and patients with hepatic impairment: Recommended dose is 1.75 mg for men and women (2.4, 2.5) 2.1 Important Administration Instructions Zolpidem tartrate sublingual tablets are to be taken in bed when a patient wakes in the middle of the night and has difficulty returning to sleep. Zolpidem tartrate sublingual tablets should only be taken if the patient has at least 4 hours of bedtime remaining before the planned time of waking [see Warnings and Precautions (5.…
Contraindications
4 CONTRAINDICATIONS Zolpidem tartrate is contraindicated in patients who have experienced complex sleep behaviors after taking zolpidem tartrate [see Warnings and Precautions (5.1)]. Zolpidem tartrate is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema [see Warnings and Precautions (5.4)]. Patients who have experienced complex sleep behaviors after taking zolpidem tartrate (4, 5.1) Known hypersensitivity to zolpidem (4)
Drug Interactions
7 DRUG INTERACTIONS CNS depressants, including alcohol: Possible adverse additive CNS depressant effects (5.1, 7.1) Imipramine: Decreased alertness observed (7.1) Chlorpromazine: Impaired alertness and psychomotor performance observed (7.1) Rifampin: Combination use may decrease effects (7.2) Ketoconazole: Combination use may increase effects (7.2) 7.1 CNS-active Drugs Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression [see Warnings and Precautions (5.1, 5.2)]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Imipramine Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance. Haloperidol A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions in zolpidem-treated patients are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [See Warnings and Precautions (5.1)] CNS-Depressant Effects and Next-Day Impairment [See Warnings and Precautions (5.2)] Serious Anaphylactic and Anaphylactoid Reactions [See Warnings and Precautions (5.2)] Abnormal Thinking and Behavioral Changes [See Warnings and Precautions (5.5)] Withdrawal Effects [See Warnings and Precautions (5.8)] Most commonly observed adverse reactions (> 1% in adult patients) are headache, nausea, and fatigue. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or http://w ww.fda.gov/medwatch . 6.1 Clinical Trials Experience The safety data described below are based on two double-blind placebo-controlled trials of zolpidem tartrate in adult patients with insomnia characterized by difficulty returning to sleep after a middle-of-the-night awakening [see Clinical Studies (14.1)]. These two trials included 230 and 82 patients treated with 3.5 mg and 1.75 mg of zolpidem tartrate, respectively. The first study was a 3-way crossov…
Frequently Asked Questions
What is Zolpidem tartrate sublingual used for?
Zolpidem tartrate sublingual is a prescription medication in tablet form that dissolves under the tongue and is used to help people who have difficulty falling asleep. It works by slowing brain activity to allow for sleep.
Is Zolpidem tartrate sublingual a controlled substance?
Yes, Zolpidem tartrate sublingual is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Zolpidem tartrate sublingual?
The generic name for Zolpidem tartrate sublingual is Zolpidem tartrate sublingual. There are no other listed brand versions of Zolpidem tartrate sublingual.
What is the NDC code for Zolpidem tartrate sublingual 1.75 mg/1?
The NDC (National Drug Code) for Zolpidem tartrate sublingual 1.75 mg/1 is 49884-898, listed by Par Health USA, LLC.
Other Zolpidem tartrate sublingual Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)