Zolpidem Tartrate Sublingual

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 Use: 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.

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 Endo at 1-800-828-9393 or FDA at 1-800-FDA-1088 or http://w ww.fda.gov/medwatch .

8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of zolpidem in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period.

WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem tartrate. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartrate immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1)]. 5 WARNINGS AND PRECAUTIONS CNS depressant effects: Impairs alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Instruct patients on correct use (5.2) Evaluate for co-morbid diagnoses: Re-evaluate if insomnia persists after 7 to 10 days of use (5.2) Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not re-challenge if such reactions occur (5.3) Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation and depersonalization have been reported. Immediately evaluate any new onset behavioral changes (5.5) Depression: Worsening of depression or suicidal thinking may occur. 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)].