ZOLPIDEM 10mg. Tablets.
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Description
Zolpidem tartrate 10mg.
DEA CLASS
Rx, schedule IV
DESCRIPTION
Non-benzodiazepine hypnotic.
Used for insomnia to aide in sleep initiation; some products may be used for middle-of-the night awakenings.
Available in immediate and extended release formulations; rapid onset and short half-life reduces ‘hangover’ effects; does not cause early-AM awakening.
COMMON BRAND NAMES
Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist
HOW SUPPLIED
Ambien CR/Zolpidem/Zolpidem Tartrate Oral Tab ER: 6.25mg, 12.5mg
Ambien/Zolpidem/Zolpidem Tartrate Oral Tab: 5mg, 10mg
Edluar/Intermezzo/Zolpidem/Zolpidem Tartrate Sublingual Tablet, SL: 1.75mg, 3.5mg, 5mg, 10mg
Zolpimist Oropharyngeal Spray Met: 1actuation, 5mg
DOSAGE & INDICATIONS
Initially, 5 mg PO immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; this is also the recommended dose for debilitated adults. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Max: 10 mg/day if needed; however, the higher dose is more likely to cause next-day impairment. Use the lowest effective dose. Administer as a single dose and do not re-administer during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment.
Initially, 5 to 10 mg PO immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; 5 mg PO immediately before bedtime is the final dose recommended for debilitated adults. 5 mg PO at bedtime provides sufficient efficacy for many men, and this lower dosage should be considered. Use the lowest effective dose. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Max: 10 mg/day if needed; however, the higher dose is more likely to cause next-day impairment. Administer as a single dose and do not re-administer during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment.
5 mg PO immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening. Use the lowest effective dose. Geriatric patients and debilitated adults are particularly sensitive to the effects of zolpidem. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Administer as a single dose and do not re-administer during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of sedative/hypnotics in long-term care facility (LTCF) residents.Max: 5 mg/day PO in residents meeting the criteria for treatment, except when documentation is provided showing that higher doses are necessary to maintain or improve the resident’s functional status. All sleep medications should be used in accordance with approved product labeling. If the sleep agent is used routinely and is beyond the manufacturer’s recommendations for duration of use, the facility should attempt a quarterly taper unless clinically contraindicated as defined in the OBRA guidelines.
Initially, 5 mg sublingually immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; this is also the recommended dose for debilitated adults. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Use the lowest effective dose. Max: 10 mg/day if needed; however, the higher dose is more likely to cause next-day impairment. Administer as a single dose and do not re-administer during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment.
Initially, 5 to 10 mg sublingually immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; 5 mg PO at bedtime provides sufficient efficacy for many men, and this lower dosage should be considered. The 5 mg dose is recommended for debilitated adults. Use the lowest effective dose. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Max: 10 mg/day if needed; however, the higher dose is more likely to cause next-day impairment. Administer as a single dose and do not re-administer during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment, including effects on driving and performing other tasks requiring complete mental alertness.
5 mg sublingually immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening. Use the lowest effective dose. Geriatric patients and debilitated adults may be particularly sensitive to the effects of the drug. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Administer as a single dose and do not be re-administer during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment, including effects on driving and performing other tasks requiring complete mental alertness. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of sedative/hypnotics in long-term care facility (LTCF) residents. In residents meeting the criteria for treatment, Max: 5 mg/day PO in residents meeting the criteria for treatment, except when documentation is provided showing that higher doses are necessary to maintain or improve the resident’s functional status. All sleep medications should be used in accordance with approved product labeling. If the sleep agent is used routinely and is beyond the manufacturer’s recommendations for duration of use, the facility should attempt a quarterly taper unless clinically contraindicated as defined in the OBRA guidelines.
Initially, 5 mg PO (1 spray in mouth over the tonque) immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; this is also the recommended dose for debilitated adults. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Max: 10 mg/day if needed; however, the higher dose is more likely to cause next-day impairment. Use the lowest effective dose. Administer as a single dose and do not re-administer during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment.
Initially, 5 to 10 mg PO (1 to 2 sprays in mouth over the tongue) immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; 5 mg (1 spray) at bedtime provides sufficient efficacy for many men, and this lower dosage should be considered. The 5 mg dose is recommended for debilitated adults. Use the lowest effective dose. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Max: 10 mg/day if needed; however, the higher dose is more likely to cause next-day impairment. Administer as a single dose and do not re-administer during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment, including effects on driving and performing other tasks requiring complete mental alertness.
5 mg PO (1 spray into mouth and over the tongue) immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening. Use the lowest effective dose. Geriatric patients and debilitated adults may be particularly sensitive to the effects of the drug. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Administer as a single dose and do not be re-administer during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment, including effects on driving and performing other tasks requiring complete mental alertness. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of sedative/hypnotics in long-term care facility (LTCF) residents. Max: 5 mg/day PO in residents meeting criteria for treatment, except when documentation is provided showing that higher doses are necessary to maintain or improve the resident’s functional status. All sleep medications should be used in accordance with approved product labeling. If the sleep agent is used routinely and is beyond the manufacturer’s recommendations for duration of use, the facility should attempt a quarterly taper unless clinically contraindicated as defined in the OBRA guidelines.
Initially, 6.25 mg PO immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening. Max: 12.5 mg/day PO at bedtime if needed; however, the higher dose is more likely to cause next-day impairment. The recommended dose for debilitated adults is 6.25 mg immediately before bedtime; these patients may be particularly sensitive to the effects of the drug. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Zolpidem should be taken as a single dose and should not be re-administered during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment, including effects on driving and performing other tasks requiring complete mental alertness.
Initially, 6.25 to 12.5 mg PO immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening. A dose of 6.25 mg PO before bedtime provides sufficient efficacy for many men, and this lower dosage should be considered. Max: 12.5 mg/day PO at bedtime if needed; however, the higher dose is more likely to cause next-day impairment. The recommended dose for debilitated adults is 6.25 mg immediately before bedtime; these patients may be particularly sensitive to the effects of the drug. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Zolpidem should be taken as a single dose and should not be re-administered during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. A full night of sleep (7 to 8 hours) is recommended to minimize the risk of next-day impairment, including effects on driving and performing other tasks requiring complete mental alertness.
6.25 mg PO immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening. Geriatric patients and debilitated adults may be particularly sensitive to the effects of the drug. Avoid co-use with other sedative-hypnotics, including other zolpidem products. During concurrent use of a CNS depressant, dosage adjustments of zolpidem and the CNS depressant may be necessary because of the potential for additive effects. Zolpidem should be taken as a single dose and should not be re-administered during the same night. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem. Patients should be cautioned regarding the risk of residual next-morning effects, and warned against engaging in hazardous activities, such as driving or other activities requiring complete mental alertness, the day after use until the patient is aware of how zolpidem affect them. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of sedative/hypnotics in long-term care facility (LTCF) residents. Max: 6.25 mg/day PO in residents meeting criteria for treatment, except when documentation is provided showing that higher doses are necessary to maintain or improve the resident’s functional status. All sleep medications should be used in accordance with approved product labeling. If the sleep agent is used routinely and is beyond the manufacturer’s recommendations for duration of use, the facility should attempt a quarterly taper unless clinically contraindicated as defined in the OBRA guidelines.
1.75 mg sublingually taken once per night if needed for a middle-of-the night awakening followed by difficulty returning to sleep. The 1.75 mg dose is also recommended for patients receiving a concomitant CNS depressant. Avoid co-use with other sedative-hypnotics, including other zolpidem products at bedtime or in the middle of the night. Use only if the patient has at least 4 hours of bedtime remaining before the planned time of waking. The risk for next-morning impairment is higher if Intermezzo is taken with less than 4 hours of bedtime remaining, if a higher than the recommended dose is taken, or during co-administration with other CNS depressants or drugs that increase the blood levels of zolpidem. Patients should be cautioned regarding the risk of residual next-morning effects, and instructed to wait for at least 4 hours after dosing and until they feel fully awake before driving or engaging in other activities requiring full mental alertness.
3.5 mg sublingually taken once per night if needed for a middle-of-the night awakening followed by difficulty returning to sleep. Use only if the patient has at least 4 hours of bedtime remaining before the planned time of waking. A lower dose of 1.75 mg sublingually is recommended for males patients taking other CNS depressants. Avoid co-use with other sedative-hypnotics, including other zolpidem products, at bedtime or in the middle of the night. The risk for next-morning impairment is higher if Intermezzo is taken with less than 4 hours of bedtime remaining, if a higher than the recommended dose is taken, or during co-administration with other CNS depressants or drugs that increase the blood levels of zolpidem. Patients should be cautioned regarding the risk of residual next-morning effects, and instructed to wait for at least 4 hours after dosing and until they feel fully awake before driving or engaging in other activities requiring full mental alertness.
1.75 mg sublingually taken once per night if needed for a middle-of-the night awakening followed by difficulty returning to sleep. Avoid co-use with other sedative-hypnotics, including other zolpidem products at bedtime or in the middle of the night. The 1.75 mg dose is also recommended for patients receiving a concomitant CNS depressant. Use only when there are at least 4 hours of bedtime remaining before the planned time of waking. The risk for next-morning impairment is higher if Intermezzo is taken with less than 4 hours of bedtime remaining, if a higher than the recommended dose is taken, or during co-administration with other CNS depressants or drugs that increase the blood levels of zolpidem. Patients should be cautioned regarding the risk of residual next-morning effects, and instructed to wait for at least 4 hours after dosing and until they feel fully awake before driving or engaging in other activities requiring full mental alertness. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of sedative/hypnotics in long-term care facility (LTCF) residents. Daily dose thresholds are not available for zolpidem use in middle-of-the night awakenings; use in accordance with approved product labeling. If the sleep agent is used routinely and is beyond the manufacturer’s recommendations for duration of use, the facility should attempt a quarterly taper unless clinically contraindicated as defined in the OBRA guidelines.
Zolpidem cannot be considered generally beneficial due to lack of well-controlled studies with statistical power, and apparent unpredictability of response. Use of zolpidem 5 to 10 mg/day PO may result in temporary clinical improvement in certain patients with disorders of consciousness (e.g., minimally conscious state (MCS) or vegetative state (VS)) due to traumatic or nontraumatic brain injury (e.g., anoxic brain injury). Clinical improvements typically occur within 1 hour of administration, with a duration of 1 to 4 hours. No long-term adverse effects were noted in 3 patients receiving the drug for 3 to 6 years. In one small double-blind trial of 15 patients with MCS or VS of various etiologies receiving a single dose of zolpidem 10 mg and placebo in a cross-over design, one post-traumatic VS patient was considered a responder as determined by the Coma Recovery Scale-Revised (CRS-R). Within 30 minutes of drug administration, the responder began to show more spontaneous movement, exploratory eye movements, visual tracking, and command following. Re-challenge showed a less dramatic but superior response to placebo. An open-label study evaluated cerebral state monitoring (CSM) and single-photon emission computed tomography (SPECT) before and after a zolpidem 10 mg PO single dose in patients with VS who were categorized by the type of brain injury. Only patients with contrecoup contusion or space-occupying compression injuries had significant improvement in components of CSM and improved cerebral perfusion on SPECT. Eight patients with primary or secondary brain stem injury had worsening of a CSM component. In 23 neurologically disabled patients (18 fully conscious, 4 MRS, and 1 locked-in syndrome) receiving zolpidem 10 mg/day for 4 months or more, the mean improvement from baseline in the Tinetti Falls Efficacy Scale (TFES) was 11.3% and brain SPECT improved in 43% of patients. There was a significantly greater decrease in TFES in patients who had improved brain scans than in patients with no brain scan improvement.
There are very limited data in pediatric patients. In one placebo-controlled trial (n = 3; pediatric patients 4 to 17 years in a persistent vegetative state due to hypoxic or traumatic brain injury) a daily dose of zolpidem 0.14 to 0.2 mg/kg PO or placebo was given for 4 days in a cross-over design with a wash-out of 10 days between treatments. Neither objective measures nor parental reports indicated increased arousal associated with zolpidem administration. Conversely, increased sedation was noted. PET scan results of regional perfusion during the zolpidem phase did not differ significantly from the placebo phase.
†Indicates off-label use
MAXIMUM DOSAGE
Immediate-release tablets (i.e., Ambien): 10 mg/day PO.
Lingual spray (i.e., Zolpimist): 10 mg/day PO.
Orally disintegrating tablets (i.e., Tovalt ODT): 10 mg/day PO.
Extended-release tablets (i.e., Ambien CR): 12.5 mg/day PO.
Sublingual tablets (i.e. Edluar): 10 mg/day SL.
Sublingual tablets (i.e., Intermezzo): 1.75 mg SL once per night in women and 3.5 mg SL once per night in men.
Immediate-release tablets (i.e., Ambien): The recommended geriatric dose is 5 mg/day PO.
Lingual spray (i.e., Zolpimist): The recommended geriatric dose is 5 mg/day PO.
Extended-release tablets (i.e., Ambien CR): The recommended geriatric dose is 6.25 mg/day PO.
Sublingual tablets (i.e. Edluar): The recommended geriatric dose is 5 mg/day SL.
Sublingual tablets (i.e., Intermezzo): The recommended geriatric dose is 1.75 mg SL once per night as needed.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
DOSING CONSIDERATIONS
Immediate-release tablets (i.e., Ambien) or Lingual spray (i.e., Zolpimist):
-mild to moderate hepatic impairment: 5 mg/day PO as needed.
-severe hepatic impairment: Avoid use as it may contribute to encephalopathy.
Extended-release tablets (i.e., Ambien CR):
-mild to moderate hepatic impairment: 6.25 mg/day PO as needed.
-severe hepatic impairment: Avoid use as it may contribute to encephalopathy.
Sublingual tablets (i.e. Edluar):
-mild to moderate hepatic impairment: 5 mg/day SL as needed.
-severe hepatic impairment: Avoid use as it may contribute to encephalopathy.
Sublingual tablets (i.e., Intermezzo):
-mild to moderate hepatic impairment: 1.75 mg SL once per night as needed.
-severe hepatic impairment: Avoid use as it may contribute to encephalopathy.
It appears that no dosage adjustments are needed. Although evidence to date does not indicate any need to use lower doses of zolpidem in patients with renal impairment or renal failure, as a general precaution these patients should be closely monitored clinically.
Intermittent hemodialysis
Zolpidem is not removed by hemodialysis. Based on limited study in end-stage renal disease patients on hemodialysis, it appears that no dosage accumulation occurs after 21 days of daily zolpidem administration. However, the manufacturers recommend close clinical monitoring of response to treatment as a general precaution.
ADMINISTRATION
A MedGuide that provides information about proper use and risks of sedative-hypnotics should be dispensed with each new prescription and refill.
Food can decrease both the rate and extent of GI absorption; instruct patients to take zolpidem on an empty stomach to facilitate the onset of sleep.
Formulations used for insomnia characterized by difficulty with sleep initiation (i.e., Ambien, Ambien CR, Zolpimist, Edluar): Administer immediately before retiring.
Formulations used for insomnia characterized by difficulty returning to sleep after a middle-of-the night awakening (i.e., Intermezzo): Administer only if there are at least 4 hours of bedtime remaining before the planned time of waking.
Immediate-release tablet (Ambien): Swallow with a drink of water. For optimal effect, do not administer with or immediately after a meal.
Extended-release tablet (Ambien CR): Zolpidem tablets should not be chewed, broken, or crushed; they should be swallowed whole with a drink of water.
Sublingual tablet (Edluar): The tablet should be placed under the tongue where it can disintegrate; it should not be swallowed. Do not take with water.
Sublingual tablet (Intermezzo): The sublingual tablet should be placed under the tongue where it can disintegrate; it should not be swallowed whole. For optimal effect, do not administer with or immediately after a meal. The foil blister containing the tablet should be removed from exterior pouch just prior to dosing. The manufacturer recommends leaving the empty pouch where it can be seen throughout the night as a reminder that a dose has been taken. This product should be used for middle-of-the night awakenings only when there is at least 4 hours of bedtime left before the planned time of waking. A Dosing Time Chart and a Dosing Time Tool are provided with the product as aides to the patient in determining the latest time during the night the product may be taken. Refer to patient Instructions for Use included with package labeling for full instructions.
Orally disintegrating tablet (Tovalt ODT): NOTE: This product is discontinued in the US. May be given with or without water. Place tablet in mouth where it can disintegrate and then be swallowed. Tablets should not be chewed, broken, or split.
Lingual spray (Zolpimist): Zolpidem may be given with or without water. Oral pump must be primed (5 pump depressions) prior to first use and re-primed (1 pump depression) if not used for 14 or more days. Spray dose directly into open mouth over the tongue. Do not inhale spray. Each spray provides 5 mg in 100 microliters. Immediately repeat a second spray if the prescribed dose is 10 mg. Replace child-resistant cover after each use; store upright. There are 60 metered actuations in each container after the 5 initial priming actuations. NOTE: Refer to Patient Instructions for Use included with package labeling for full instructions.
STORAGE
Ambien:
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Ambien CR:
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Edluar:
– Protect from light
– Protect from moisture
– Store at controlled room temperature (between 68 and 77 degrees F)
Intermezzo:
– Do not store outside the pouch provided
– Protect from moisture
– Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Zolpimist:
– Avoid temperatures above 86 degrees F
– Do not freeze
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
– Store upright
CONTRAINDICATIONS / PRECAUTIONS
Zolpidem should be avoided in those with a hypersensitivity to zolpidem or any ingredient in the product. Reactions including anaphylaxis or angioedema may occur with sedative-hypnotics, and may become evident as early as the initial dose. Patients should be instructed on the appropriate action in the event of an allergic reaction. Treatment with zolpidem should not be reinitiated in patients who experience angioedema after administration of the drug.
Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia or sleep disorders with zolpidem should be initiated only after a careful evaluation of the patient. The failure of the sleep disturbance to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem. Because some adverse effects of zolpidem appear to be dose-related, it is important to use the lowest possible effective dose. A variety of abnormal thinking and behavioral changes have been reported to occur in association with the use of sedative/hypnotics, including zolpidem. Some of these changes included decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation and depersonalization. Visual and auditory hallucinations have been reported. Amnesia and other neuropsychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (suicidal ideation, including completed suicides), has been reported in association with the use of sedative/hypnotics. Intentional overdosage is more common in patients with depression; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time. The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
Zolpidem has a rapid onset of action and causes CNS depressant activity. Zolpidem products indicated for insomnia due to difficulty with sleep initiation should only be administered immediately prior to retiring and with at least 7 to 8 hours remaining before the planned time of waking. Zolpidem products indicated for difficulty returning to sleep after middle-of-the-night awakenings should only be taken while the patient is in bed and has at least 4 hours of bedtime remaining before the planned time of waking. Vehicle drivers and machine operators should be warned that hypnotics, such as zolpidem, have a possible risk of adverse reactions including drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision, reduced alertness and impaired driving, even the day after use. Patients should be instructed to avoid driving or operating machinery or performing other tasks requiring mental alertness for at least 8 hours after taking immediate-release formulations, and patients receiving the extended-release formulation should be alerted about the potential impact on such activities the full day after use. Patients receiving zolpidem for middle-of-the-night awakenings should wait for at least 4 hours after dosing and until they feel fully awake before driving or engaging in other activities requiring full mental alertness. Alterations in CNS functioning caused by zolpidem may lead to falls and subsequent severe injuries; zolpidem use has been associated with severe injuries such as hip fractures and intracranial hemorrhage. Due to gender differences in the elimination of zolpidem, a lower initial dose is recommended in adult females (women). Plasma levels of zolpidem in some patients, particularly women, may be high enough the morning after use to impair activities requiring mental alertness, such as driving. The risk for next-morning impairment is higher if zolpidem products are taken without adherence to the proper hours for sleep recommended following use or if a higher than the recommended dose is taken. Risks for impairment are also increased during coadministration with other CNS depressants with zolpidem or with use of drugs that increase the blood levels of zolpidem. Concurrent alcohol or CNS depressant use increases the risk for CNS depression, impairment, complex behaviors and other additive effects. Patients taking zolpidem should avoid ethanol ingestion. Lower initial dosages of zolpidem should be considered in patients taking other CNS-depressant therapies concurrently. Sedative-hypnotics like zolpidem can cause complex sleep-related behaviors such as phone calls, sexual activity, preparing and eating food, or sleep-driving, a state of driving after ingestion of a sedative-hypnotic while not fully awake and having no memory of the event or amnesia. The exact incidences among various sedative products are unknown; however patients should be informed of the risks prior to receiving any medication from this class. Anterograde amnesia may be particularly evident at zolpidem doses above 10 mg/day. Due to the risk to the patient and the general public, discontinuation of zolpidem should be strongly considered for patients who report a sleep-driving episode or other potentially harmful sleep-related complex behaviors.
Immediate-release zolpidem is recommended for use in the short-term treatment of insomnia. No such recommendation exists in the package labeling for extended-release zolpidem, although cautious use is prudent when prescribing any hypnotic. Problems associated with abrupt discontinuation of hypnotic drugs are more likely to occur following chronic therapy. There is no reliable data documenting the occurrence of withdrawal symptoms following discontinuation of zolpidem, but evidence of fatigue, nausea/vomiting, flushing, lightheadedness, inconsolable crying, stomach cramps, panic attack, nervousness, and abdominal discomfort may constitute a withdrawal syndrome. Rare postmarketing reports of abuse, dependence, and withdrawal have been received. Withdrawal of some hypnotics also precipitates a rebound insomnia. If therapy is continued for more than 2 weeks the possibility of a withdrawal syndrome should be considered and abrupt discontinuation of therapy avoided. The possibility of physical and psychological dependence to zolpidem requires close monitoring. Zolpidem should be used cautiously in patients with a history of alcoholism or substance abuse.
Zolpidem should be administered cautiously to patients with hepatic disease because the elimination half-life of the drug can be prolonged, with possible resultant toxicity. Patients with hepatic insufficiency do not clear zolpidem as rapidly as patients with normal hepatic function. Patients with mild to moderate hepatic disease (e.g., Child Pugh class A or B) should receive a lower initial dosage (i.e., 5 mg/day). Avoid zolpidem use in patients with severe hepatic impairment (e.g., Child Pugh class C) since the drug may contribute to encephalopathy. Gamma-aminobutyric acid (GABA) agonists, such as zolpidem, have been associated with the development of hepatic encephalopathy in patients with hepatic insufficiency.
Postmarketing reports indicate that respiratory insufficiency or oxygen desaturation may occur in some patients treated with zolpidem, mostly in patients with pre-existing pulmonary disease. Zolpidem should be used with caution in patients with pre-existing respiratory depression, such as severe chronic obstructive pulmonary disease (COPD), sleep apnea, or myasthenia gravis to avoid the risk of depressing ventilatory function.
Available data from observational studies, birth registries, and case reports on the use of zolpidem during human pregnancy have not reported a clear association with the drug and major birth defects. Zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates with in utero exposure during the later stages of pregnancy; there are a limited number of exposed neonatal cases of moderate to severe respiratory depression requiring aspiration, artificial ventilation, or intratracheal intubation. The majority of neonates recovered within hours to a few weeks after birth once treated. Neonatal flaccidity has also been reported in infants born to mothers who have received sedatives during pregnancy. Newborns who have been exposed to zolpidem during pregnancy and labor should be monitored for signs of sedation and respiratory depression and managed accordingly. Withdrawal symptoms may also be possible during the postnatal period. Zolpidem has no established use during labor or obstetric delivery.
The developmental and health benefits of breast-feeding should be assessed along with the mother’s clinical need for zolpidem and potential adverse effects on the breastfed infant from zolpidem or any underlying maternal condition. Zolpidem is excreted into breast milk, and there are reports of excess sedation in babies exposed to zolpidem through breast milk; therefore, it is recommended to monitor the breast-fed infant for excess sedation, hypotonia, and respiratory depression. Alternatively, a lactating woman may consider interrupting breast-feeding and pumping and discarding breast milk during treatment and for 23 hours (about 5 half-lives) after zolpidem administration to minimize infant drug exposure. In one small study of lactating women (n = 5) who received a single 20 mg dose of zolpidem on postpartum day 3 or 4, the mean milk to maternal plasma concentration ratio was 0.13 (range, 0.11 to 0.18) three hours after drug administration. The amount of zolpidem measured in the breast milk samples represented 0.004% to 0.019% of the maternal administered dose. No detectable zolpidem was measured in subsequent milk samples taken at 13 and 16 hours after the dose. Breast-feeding was discontinued for 24 hours after drug administration; therefore, infant exposure was not assessed. The transfer of zaleplon, an alternative sedative, into breast milk has also been assessed; however, the effects of zaleplon exposure on the breast-feeding infant have not been formally evaluated.[31451] [40336] [44125] [45971] [46915] [57789]
The safety and efficacy of zolpidem in pediatric patients have not been established and the drug cannot be recommended for use in children, adolescents or infants. Studies of zolpidem in pediatric patients have not suggested efficacy of the drug over placebo, and, adverse events were frequent. Results of a controlled 8-week study for the treatment of insomnia in 201 children aged 6 to 17 years with attention-deficit hyperactivity disorder (ADHD) indicated that zolpidem was not effective compared to placebo. One or more adverse events was experienced in 62.5% of pediatric patients treated with zolpidem (dizziness [23.5%], headaches [23.5%], and hallucinations [7.4%]).
Debilitated and/or geriatric patients may be more sensitive to the effects of zolpidem. In 3-week controlled trials, the adverse event profile of zolpidem extended-release was similar in elderly and younger adult populations. However, the impairment of cognitive and motor function may be more marked in the elderly and a lower initial dosage is recommended together with close monitoring. During studies evaluating sleep after discontinuation of zolpidem, elderly patients reported impaired sleep on the first post-treatment night after using doses above 5 mg/day. No objective evidence of rebound insomnia was observed at recommended doses. Elderly patients who receive greater than 5 mg/day of zolpidem immediate-release or greater than 6.25 mg/day of zolpidem extended-release may especially be at risk for falls or mental status changes. According to the Beers Criteria, zolpidem is considered a potentially inappropriate medication (PIM) in geriatric patients and use should be avoided; benzodiazepine-receptor agonists such as zolpidem may produce similar adverse effects as benzodiazepines in older adults, such as falls, fractures, and delirium. There are increased emergency department visits, hospitalizations, and motor vehicle crashes, as well as minimal improvement in sleep latency and duration in older adults. The Beers expert panel also recommends avoiding zolpidem in geriatric patients with dementia or cognitive impairment due to the potential for drug-induced adverse CNS effects, or those with delirium or at high risk of delirium since new-onset or worsening delirium may occur. In addition, the Beers expert panel recommends avoiding zolpidem in elderly patients with a history of falls or fractures, unless safer alternatives are not available, since zolpidem can produce ataxia, impaired psychomotor function, syncope, and additional falls; if zolpidem must be used, consider reducing use of other CNS-active medications that increase the risk of falls and fractures and implement other strategies to reduce fall risk. The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents of long-term care facilities (LTCFs). According to the OBRA guidelines, factors potentially causing insomnia should be evaluated before initiating a sedative (e.g., sleep environment, inadequate physical activity, provision of care disruptions, caffeine or medications, pain and discomfort, or other underlying conditions that cause insomnia). Most cases of insomnia are associated with other underlying conditions. It is expected that non-pharmacologic interventions and maximized treatment of underlying conditions (if applicable) are implemented to address the causative factor(s). Initiation of sleep induction or maintenance medication should be preceded or accompanied by other interventions to attempt sleep improvement. All sleep medications should be used in accordance with approved product labeling. The use of sedating medications for individuals with diagnosed sleep apnea requires careful assessment, documented clinical rationale, and close monitoring. Exceptions to the OBRA provisions include: single dose sedative use for a dental or medical procedure or short-term sedative use during initiation of treatment for depression, pain, or other comorbid condition until symptoms improve or the underlying causative factor can be identified and/or effectively treated. OBRA provides dosing guidance for most sedatives, including zolpidem. When a drug is being used to induce sleep or treat a sleep disorder, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines.
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