1 INDICATIONS AND USAGE Zolpidem Tartrate is 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 ( 1 ) 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 ( 1 ) Zolpidem Tartrate Sublingual Tablet is 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 Use : Zolpidem Tartrate Sublingual Tablet is 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.

6 ADVERSE REACTIONS Most commonly observed adverse reactions (> 1% in adult patients) are headache, nausea, and fatigue.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc.

at 1-866-403-7592 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch 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) ] 6.1 Clinical Trials Experience The safety data described below are based on two double-blind placebo-controlled trials of Zolpidem Tartrate Sublingual Tablets 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 Sublingual Tablets, 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 Sublingual Tablets 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 Sublingual Tablets 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 Sublingual Tablets 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 Sublingual Tablet-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 Sublingual Tablets 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 Zolpidem Tartrate Sublingual Tablets ( 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%