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Zolpimist Generic Name & Formulations
Legal Class
CIV
General Description
Zolpidem tartrate 5mg per metered actuation (one spray) in 100microliter; oral solution spray; cherry-flavored.
Pharmacological Class
Imidazopyridine hypnotic.
How Supplied
Pump—4.8g (30 actuations); 8.22g (60 actuations)
Manufacturer
Generic Availability
NO
Zolpimist Indications
Indications
Short-term treatment of insomnia (w. difficulties in sleep initiation).
Zolpimist Dosage and Administration
Adult
Use lowest effective dose. Effects delayed if taken with or after a meal. Spray directly into mouth over the tongue. Take once per night immediately before bedtime (with at least 7–8hrs remaining before planned time of awakening). Women: initially 5mg (one actuation). Men: initially 5mg or 10mg (two actuations). Both: if 5mg ineffective, may increase to max 10mg. Elderly, debilitated, or hepatic impairment: 5mg.
Children
<18yrs: not recommended.
Zolpimist Contraindications
Contraindications
Prior history of complex sleep behaviors with Zolpimist.
Zolpimist Boxed Warnings
Boxed Warning
Complex sleep behaviors.
Zolpimist Warnings/Precautions
Warnings/Precautions
Risk of complex sleep behaviors (eg, sleep-walking, sleep-driving, engaging in other activities while not fully awake); discontinue immediately if occur. Monitor for CNS depressant effects and next-day impairment. Evaluate for co-morbid diagnoses (eg, physical and/or psychiatric disorders) prior to treatment. Reevaluate if insomnia fails to remit after 7–10 days of use. Depression. Suicidal tendencies. Evaluate any new onset of behavioral changes. Compromised respiratory function. Sleep apnea. Myasthenia gravis. Conditions that affect metabolism or hemodynamic response. Drug or alcohol abuse. Hepatic or renal impairment; monitor. Avoid abrupt cessation. Write ℞ for smallest practical amount. Elderly (higher risk of falls). Debilitated. Pregnancy (Cat.C). Nursing mothers.
Zolpimist Pharmacokinetics
See Literature
Zolpimist Interactions
Interactions
Concomitant other sedative-hypnotics including other zolpidem products: not recommended. Potentiates CNS depression with alcohol, other CNS depressants (eg, benzodiazepines, opioids, tricyclics); adjust dose. May be potentiated by CYP3A4 inhibitors (eg, ketoconazole; consider lower zolpidem dose), sertraline. May be antagonized by CYP3A4 inducers (eg, rifampin). Decreased alertness with imipramine, chlorpromazine.
Zolpimist Adverse Reactions
Adverse Reactions
Drowsiness, dizziness, diarrhea, drugged feelings (long-term); abnormal thinking and behavioral changes; rare: anaphylaxis, angioedema (do not rechallenge).
Zolpimist Clinical Trials
See Literature
Zolpimist Note
Not Applicable
Zolpimist Patient Counseling
See Literature
