Zolpidem tartrate sublingual

Zolpidem tartrate sublingual is an FDA-registered drug product whose active ingredient is ZOLPIDEM TARTRATE SUBLINGUAL. It is labelled by Par Health USA, LLC taken by sublingual and marketed as a human prescription drug product. Identifiers on file: NDC 49884-898, application ANDA204229, label effective 20260415. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ZOLPIDEM TARTRATE SUBLINGUAL are most often described in connection with: zolpidem tartrate, sublingual tablets, treatment insomnia, middle-of-the-night awakening, followed difficulty, returning sleep, hours bedtime, planned time. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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 (5.1)]. Zolpidem tartrate sublingual tablets should be placed under the tongue and allowed to disintegrate completely before swallowing. The tablet should not be swallowed whole. For optimal effect, Zolpidem tartrate sublingual tablets should not be administered with or immediately after a meal. The tablet should be removed from the pouch just prior to dosing. 2.2 Basic Dosing Information The recommended and maximum dose of zolpidem tartrate sublingual tablets are 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. The recommended doses for women and men are different because women clear zolpidem from the body at a lower rate than men [see Use in Specific Populations (8.6)] . 2.3 Use with CNS Depressants The recommended zolpidem tartrate sublingual tablets dose for men and women who are taking concomitant CNS depressants is 1.75 mg. Dose adjustment of concomitant CNS depressants may be necessary when co-administered with zolpidem tartrate sublingual tablets because of potentially additive effects. The use of zolpidem tartrate sublingual tablets with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see Warnings and Precautions (5.1)]. 2.4 Use in Geriatric Patients Geriatric patients may be especially sensitive to the effects of zolpidem. The recommended dose of zolpidem tartrate sublingual tablets in men and women over 65 years old is 1.75 mg, taken only once per night if needed [see Use in Specific Populations (8.5)]. 2.5 Use in Patients with Hepatic Impairment The recommended dose of zolpidem tartrate sublingual tablets in patients with hepatic impairment is 1.75 mg, taken only once per night if needed [see Clinical Pharmacology (12.3)].

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)

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 crossover sleep-laboratory study in 82 patients (58 female and 24 male; median age 47 years; 51% Caucasian, 44% African-American) of 1.75 mg and 3.5 mg of zolpidem tartrate compared to placebo (Study 1). The second study was a 4-week, parallel-group at-home study in 295 patients (201 female and 94 male; median age 43 years) of 3.5 mg of zolpidem tartrate compared to placebo, used on an as-needed basis after spontaneous middle-of-the-night awakenings (Study 2). In Study 2, patients took zolpidem tartrate during the night on 62% of study nights. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in actual practice. Table 1 shows the incidence of adverse reactions reported in Study 2 that occurred in 2% or more of zolpidem tartrate-treated (3.5 mg) patients in which the incidence was greater than the incidence in placebo-treated patients. For women and other patients taking the 1.75 mg dose in Study 1, the incidence of adverse reactions was similar to the incidence seen with 3.5 mg of zolpidem tartrate in Table 1. The most commonly reported adverse reactions in all treatment groups were headache, nausea, and fatigue. Table 1: Summary of Adverse Reactions (≥ 2%) in Outpatient, Double-Blind, Parallel-Group, Placebo-Controlled Study (Study 2) MedDRA System Organ Class Preferred Term 3.5 mg Z olpidem Tartrate (n=150) Placebo (n=145) Gastrointestinal Disorders 4% 2% Nausea 1% 1% General Disorders and Administration Site Conditions 3% 0% Fatigue 1% 0% Nervous System Disorders 5% 3% Headache 3% 1%

3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Zolpidem tartrate sublingual used for?
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 …

Who makes Zolpidem tartrate sublingual?
Par Health USA, LLC is the labeler of record for Zolpidem tartrate sublingual.

What form does Zolpidem tartrate sublingual come in?
administered by sublingual. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Zolpidem tartrate sublingual prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Zolpidem tartrate sublingual been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.