Nitrest
Cheaper & Alternative Brands
Same generic (Zolpidem Tartrate), same form (Tablet)No other brands currently registered with this exact active generic and dosage form.
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Nitrest Capsules, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than age 65 years of age.
Contraindications
Zolpidem Tartrate Capsules are contraindicated in patients:
who have experienced complex sleep behaviors after taking zolpidem
with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema
Side Effects & Adverse Reactions
Most commonly observed adverse reactions: headache, drowsiness, dizziness, and diarrhea.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Complex Sleep Behaviors
CNS-Depressant Effects and Next-Day Impairment
Severe Anaphylactic and Anaphylactoid Reactions
Abnormal Thinking and Behavior Changes
Withdrawal Effects
Warnings & Precautions
CNS-Depressant Effects
: Impaired alertness and motor coordination including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients against driving and other activities requiring mental alertness the morning after use. Instruct patients on correct use.
Need to Evaluate for Comorbid Diagnoses
: Reevaluate if insomnia persists after 7 to 10 days of use.
Severe Anaphylactic/Anaphylactoid Reactions
: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.
Abnormal Thinking and Behavioral Changes
: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported. Immediately evaluate any new onset behavioral changes.
Depression
: Worsening of depression or suicidal thinking may occur. Prescribe the least amount of capsules feasible to avoid intentional overdose.
Respiratory Depression
: Consider this risk before prescribing in patients with compromised respiratory function.
Precipitation of Hepatic Encephalopathy
: Avoid Nitrest in patients with severe hepatic impairment.
Withdrawal Effects
: Symptoms may occur with rapid dose reduction or discontinuation.
Pharmacology & Mechanism of Action
Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of transient insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation. Zolpidem binds to GABA A receptors with greater affinity for α1 subunit relative to α2 and α3 subunit containing receptors. Zolpidem has no appreciable binding affinity for α5 subunit containing GABA A receptors. This binding profile may explain the relative absence of myorelaxant effects in animal studies. Zolpidem has no appreciable binding affinity for dopaminergic D2, serotonergic 5HT2, adrenergic, histaminergic or muscarinic receptors.