Sleep-wake disorders:

Indications for: ZOLPIMIST

Short-term treatment of insomnia (w. difficulties in sleep initiation).

Adult Dosage:

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 Dosage:

<18yrs: not recommended.

ZOLPIMIST Contraindications:

Prior history of complex sleep behaviors with Zolpimist.

Boxed Warning:

Complex sleep behaviors.

ZOLPIMIST 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 Classification:

Imidazopyridine hypnotic.

ZOLPIMIST 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.

Adverse Reactions:

Drowsiness, dizziness, diarrhea, drugged feelings (long-term); abnormal thinking and behavioral changes; rare: anaphylaxis, angioedema (do not rechallenge).

Generic Drug Availability:

NO

How Supplied:

Pump—4.8g (30 actuations); 8.22g (60 actuations)