Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
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.
Like all medications, Zolpidem Tartrate Sublingual can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: