Generic Name and Formulations:
Zolpidem tartrate 1.75mg, 3.5mg; sublingual tablets.
Purdue Pharma L.P.
Indications for INTERMEZZO:
As needed use for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Not indicated for treatment of middle-of-the-night insomnia when patient has <4 hours of bedtime remaining before planned time of waking.
Place 1 tab under the tongue and allow to disintegrate completely before swallowing. ≥18yrs: 1.75mg (women) or 3.5mg (men) (take only once per night if needed and only if at least 4 hours of bedtime remain before the planned time of waking). Concomitant CNS depressants, elderly (≥65yrs), hepatic impairment: 1.75mg (men and women). Effect delayed if taken with or immediately after a meal.
<18yrs: not recommended.
Risk of CNS depressant effects and next-day impairment. Evaluate for co-morbid diagnoses (eg, physical and/or psychiatric disorders) prior to treatment. Reevaluate if insomnia persists after 7–10 days of use. Monitor for new onset behavioral changes, worsening of depression, or suicidal thinking. Compromised respiratory function. Sleep apnea. Myasthenia gravis. Hepatic impairment. Drug or alcohol abusers. Write ℞ for smallest practical amount. Elderly. Pregnancy (Cat.C). Nursing mothers.
Additive effects with concomitant other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, imipramine, chlorpromazine or alcohol); reduce dose. Concomitant with other sedative-hypnotics including other zolpidem products: not recommended. Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole). Reduced exposure by CYP3A4 inducers (eg, rifampin).
Headache, nausea, fatigue; CNS effects, abnormal thinking, complex sleep-related behaviors (eg, sleep-driving), anaphylaxis, angioedema, others (see literature).