(zole PI dem)
Insomnia:
Ambien, Edluar, Zolpimist: Short-term treatment of insomnia with difficulty of sleep onset
Ambien CR: Treatment of insomnia with difficulty of sleep onset and/or sleep maintenance
Intermezzo: As needed" treatment of insomnia when middle-of-the-night awakening is followed by difficulty returning to sleep and the patient has ≥4 hours of sleep time remaining
Sublinox [Canadian product]: Short-term treatment of insomnia (with difficulty of sleep onset, frequent awakenings, and/or early awakenings)
Hypersensitivity to zolpidem or any component of the formulation
Canadian labeling: Additional contraindications (not in U.S. labeling): Significant obstructive sleep apnea syndrome and acute and/or severe impairment of respiratory function; myasthenia gravis; severe hepatic impairment; personal or family history of sleepwalking
Insomnia: Oral: Note: The lowest effective dose should be used; higher doses may be more likely to impair next morning activities.
Immediate release tablet, spray: 5 mg (females) or 5 to 10 mg (males) immediately before bedtime; maximum dose: 10 mg daily
Extended release tablet: 6.25 mg (females) or 6.25 to 12.5 mg (males) immediately before bedtime; maximum dose: 12.5 mg daily
Sublingual tablet:
Edluar, Sublinox [Canadian product]: 5 mg (females) or 5 to 10 mg (males) immediately before bedtime; if 5 mg dose is ineffective may increase to 10 mg (maximum dose: 10 mg daily)
Intermezzo: Note: Take in bed only if ≥4 hours left before waking and there is difficulty in returning to sleep
Females: 1.75 mg once per night as needed (maximum: 1.75 mg/night)
Males: 3.5 mg once per night as needed (maximum: 3.5 mg/night)
Dosage adjustment with concomitant CNS depressants: Females and males: 1.75 mg once per night as needed; dose adjustment of concomitant CNS depressant(s) may be necessary.
Debilitated:
Immediate release tablet, spray: 5 mg immediately before bedtime
Sublingual tablet:
Edluar, Sublinox [Canadian product]: 5 mg immediately before bedtime
Extended release tablet: 6.25 mg immediately before bedtime
Oral:
Immediate release tablet, spray: 5 mg immediately before bedtime
Sublingual tablet:
Edluar, Sublinox [Canadian product]: 5 mg immediately before bedtime
Intermezzo: Females and males: 1.75 mg once per night as needed (maximum: 1.75 mg/night). Note: Take in bed only if ≥4 hours left before waking and there is difficulty in returning to sleep.
Extended release tablet: 6.25 mg immediately before bedtime
No dosage adjustment necessary.
Hemodialysis: Not dialyzable
U.S. labeling:
Immediate release tablet, spray: 5 mg immediately before bedtime
Extended release tablet: 6.25 mg immediately before bedtime
Sublingual tablet:
Edluar: 5 mg immediately before bedtime
Intermezzo: Females and males: 1.75 mg once per night as needed. Note: Take in bed only if ≥4 hours left before waking and there is difficulty in returning to sleep.
Canadian labeling: Sublingual tablet: Sublinox:
Mild-to-moderate impairment: 5 mg immediately before bedtime
Severe impairment: Use is contraindicated.
Administer immediately before bedtime due to rapid onset of action. Regardless of dosage form, do not administer with or immediately after a meal (may delay onset). Intermezzo should be taken in bed if patient awakes in the middle of the night (ie, if ≥4 hours left before waking) and there is difficulty in returning to sleep.
Ambien CR: Swallow tablet whole; do not divide, crush, or chew.
Edluar, Intermezzo, or Sublinox [Canadian product]: Place sublingual tablet under the tongue and allow to disintegrate; do not swallow or administer Edluar or Sublinox with water.
Zolpimist oral spray: Spray directly into the mouth over the tongue. Prior to initial use, prime pump by spraying 5 times. If pump is not used for at least 14 days, reprime pump with 1 spray.
Do not administer with or immediately after a meal (may delay onset).
Ambien, Edluar, Intermezzo: Store at 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F). Protect sublingual tablets from light and moisture.
Ambien CR: Store at 15 ‚ °C to 25 ‚ °C (59 ‚ °F to 77 ‚ °F); limited excursions permitted up to 30 ‚ °C (86 ‚ °F).
Zolpimist: Store upright at 25 ‚ °C (77 ‚ °F); excursions permitted to 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F). Do not freeze. Avoid prolonged exposure to temperatures >30 ‚ °C (86 ‚ °F).
Sublinox [Canadian product]: Store at 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F); protect from light and moisture.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Oral, as tartrate:
Zolpimist: 5 mg/actuation (7.7 mL [DSC]) [contains benzoic acid, propylene glycol; cherry flavor]
Tablet, Oral, as tartrate:
Ambien: 5 mg [contains fd&c red #40, polysorbate 80]
Ambien: 10 mg
Generic: 5 mg, 10 mg
Tablet Extended Release, Oral, as tartrate:
Ambien CR: 6.25 mg
Ambien CR: 12.5 mg [contains fd&c blue #2 (indigotine)]
Generic: 6.25 mg, 12.5 mg
Tablet Sublingual, Sublingual, as tartrate:
Edluar: 5 mg, 10 mg [contains saccharin sodium]
Intermezzo: 1.75 mg, 3.5 mg
Generic: 1.75 mg, 3.5 mg
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy
Antifungal Agents (Azole Derivatives, Systemic): May increase the serum concentration of Zolpidem. Applicable Isavuconazonium considerations are addressed in separate monographs. Exceptions: Isavuconazonium Sulfate; Posaconazole. Monitor therapy
Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination
Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification
Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification
Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
CarBAMazepine: Zolpidem may enhance the CNS depressant effect of CarBAMazepine. CarBAMazepine may decrease the serum concentration of Zolpidem. Management: Monitor zolpidem response closely. Reduce the Intermezzo brand sublingual zolpidem dose to 1.75 mg for men who are also receiving carbamazepine. No such dose change is recommended for women. Monitor therapy
CNS Depressants: May enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification
CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification
Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Dimethindene: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification
Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification
Flumazenil: May diminish the sedative effect of Hypnotics (Nonbenzodiazepine). Monitor therapy
Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification
FluvoxaMINE: May enhance the CNS depressant effect of Zolpidem. FluvoxaMINE may increase the serum concentration of Zolpidem. Monitor therapy
HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Consider starting with a 20% to 30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may also be warranted. Consider therapy modification
Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy
Ketoconazole (Systemic): May increase the serum concentration of Zolpidem. Management: Consider using a lower starting dose of zolpidem in patients receiving ketoconazole and monitor for increased zolpidem effects/toxicities if these agents are combined. Consider therapy modification
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification
MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy
Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification
Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination
Osimertinib: May increase the serum concentration of CYP3A4 Substrates. Osimertinib may decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: When oxycodone is combined with another CNS depressant, a dose reduction of one or both agents should be considered. The extended release oxycodone starting dose should be reduced 50% to 67% when initiated in patients already receiving CNS depressants. Consider therapy modification
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination
Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification
Piribedil [INT]: CNS Depressants may enhance the CNS depressant effect of Piribedil [INT]. Monitor therapy
Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy
Rifamycin Derivatives: May decrease the serum concentration of Zolpidem. Management: Seek alternatives. If used together, monitor for decreased therapeutic effects of zolpidem if a rifamycin derivative is initiated/dose increased, or increased effects if a rifamycin derivative is discontinued/dose decreased. Consider therapy modification
Ritonavir: May increase the serum concentration of Zolpidem. Monitor therapy
ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy
Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy
Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Sodium Oxybate: Hypnotics (Nonbenzodiazepine) may enhance the CNS depressant effect of Sodium Oxybate. Avoid combination
St Johns Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification
Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification
Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to one-half of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for evidence of excessive CNS depression. Consider therapy modification
Telaprevir: May decrease the serum concentration of Zolpidem. Monitor therapy
Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Daytime alertness; fall risk, respiratory rate (patients with compromised respiration); behavior profile; tolerance, abuse, and dependence; reevaluate if insomnia persists after 7 to 10 days of use.
Increased aminotransferase [ALT/AST], bilirubin (S); decreased RAI uptake
Actual frequency may be dosage form, dose, and/or age dependent
>10%: Central nervous system: Headache (3% to 19%), drowsiness (2% to 15%), dizziness (5% to 12%)
1% to 10%:
Cardiovascular: Chest discomfort, increased blood pressure, palpitations
Central nervous system: Fatigue (1%), abnormal dreams, amnesia, anxiety, apathy, ataxia, burning sensation, confusion, depersonalization, depression, disinhibition, disorientation, drugged feeling, eating disorder (binge eating), emotional lability, equilibrium disturbance, euphoria, hallucination, hypoesthesia, increased body temperature, insomnia, lack of concentration, lethargy, memory impairment, paresthesia, psychomotor retardation, sleep disorder, stress, vertigo
Dermatologic: Skin rash, urticaria, wrinkling of skin
Endocrine & metabolic: Hypermenorrhea
Gastrointestinal: Abdominal distress, abdominal tenderness, change in appetite, constipation, diarrhea, dyspepsia, flatulence, frequent bowel movements, gastroenteritis, gastroesophageal reflux disease, hiccups, nausea, vomiting, xerostomia
Genitourinary: Dysuria, urinary tract infection, vaginal dryness
Hypersensitivity: Hypersensitivity reaction
Neuromuscular & skeletal: Arthralgia, back pain, muscle cramps, muscle spasm, myalgia, neck pain, tremor, weakness
Ophthalmic: Accommodation disturbance, asthenopia, blurred vision, diplopia, eye redness, visual disturbance (including altered depth perception)
Otic: Labyrinthitis, tinnitus
Respiratory: Dry throat, flu-like symptoms, lower respiratory tract infection, pharyngitis, sinusitis, throat irritation, upper respiratory tract infection
Miscellaneous: Fever
<1% (Limited to important or life-threatening): Abnormal hepatic function tests, acute renal failure, aggressive behavior, anaphylaxis, anemia, angina pectoris, angioedema, anorexia, arteritis, arthritis, breast fibroadenosis, breast neoplasm, bronchitis, cardiac arrhythmia, cerebrovascular disease, circulatory shock, cognitive dysfunction, corneal ulcer, delusions, dementia, dermatitis, drug tolerance, dysarthria, dysphagia, edema, extrasystoles, glaucoma, hepatic insufficiency, hyperbilirubinemia, hyperglycemia, hyperlipidemia, hypertension, hypotension, hysteria, illusion, impotence, leukopenia, lymphadenopathy, migraine, myocardial infarction, neuralgia, neuritis, neuropathy, orthostatic hypotension, panic disorder, personality disorder, psychoneurosis, pulmonary edema, pulmonary embolism, pyelonephritis, respiratory depression, restless leg syndrome, rhinitis, scleritis, somnambulism, syncope, tachycardia, tenesmus, tetany, thrombosis, urinary incontinence, vaginitis, ventricular tachycardia
Cmax and AUC were found to be 2 and 5 times higher, respectively, in hepatically compromised patients.
Immediate-release tablet: Cmax, half-life, and AUC were significantly increased when compared with results in younger adults.
ER tablet: Mean Cmax and mean AUC are 70.6 ng/mL and 413 ng -h/mL, respectively, while the median Tmax is 2 hours.
Cmax and AUC were higher when comparing the same dose in women with men. Women clear zolpidem from the body at a lower rate than men. In geriatric patients, clearance is similar between men and women.
Concerns related to adverse effects:
- Abnormal thinking/behavioral changes: Hypnotics/sedatives have been associated with abnormal thinking and behavior changes including decreased inhibition (eg, aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation, visual and auditory hallucinations, and depersonalization. These changes may occur unpredictably and may indicate previously unrecognized psychiatric disorders; evaluate appropriately.
- CNS depression: May cause CNS depression impairing physical and mental capabilities; patients must be cautioned about performing tasks which require mental alertness (operating machinery or driving). An increased risk of next-day psychomotor impairment is increased if patient is unable to stay in bed for a full night of sleep (7 to 8 hours); if coadministered with other CNS depressants and/or taken with other drugs that increase blood levels of zolpidem; or if a higher than recommended dose is taken. Dose adjustment may be necessary if taking concomitant CNS depressants; use with alcohol is not recommended. Intermezzo should be taken in bed if patient awakes in the middle of the night (ie, if ≥4 hours left before waking) and there is difficulty in returning to sleep.
- Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis as well as angioedema, have been reported after taking the first or subsequent doses. Do not rechallenge patient if such reactions occur.
- Sleep-related activities: An increased risk for hazardous sleep-related activities such as sleep-driving, preparing and eating food, making phone calls, or having sex while asleep have also been noted; amnesia, anxiety, and other neuropsychiatric symptoms may also occur. Patients usually do not remember these events. The use of alcohol, other CNS depressants, and exceeding the recommended maximum dose may increase the risk of these activities. Discontinue treatment in patients who report any sleep-driving episodes. Canadian labeling recommends avoiding use in patients with disorders (eg, restless legs syndrome, periodic limb movement disorder, sleep apnea) that may disrupt sleep and cause frequent awakenings, potentially increasing the risk of complex sleep-related behaviors.
Disease-related concerns:
- Depression: Use with caution in patients with depression; worsening of depression, including suicide or suicidal ideation has been reported with the use of hypnotics. Intentional overdose may be an issue in this population. The minimum dose that will effectively treat the individual patient should be used. Prescriptions should be written for the smallest quantity consistent with good patient care.
- Drug abuse: Use with caution in patients with a history of drug dependence. Risk of abuse is increased in patients with a history or family history of alcohol or drug abuse or mental illness.
- Hepatic impairment: Use with caution in patients with hepatic impairment; dose adjustment recommended. Canadian labeling contraindicates use in severe hepatic impairment.
- Myasthenia gravis: Use with caution in patients with myasthenia gravis. Canadian labeling contraindicates use in myasthenia gravis.
- Respiratory disease: Use with caution in patients with respiratory compromise, COPD, or sleep apnea. Canadian labeling contraindicates use in significant obstructive sleep apnea syndrome and acute and/or severe impairment of respiratory function.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Special populations:
- Debilitated: Use with caution in debilitated patients; potential for oversedation, impaired coordination, and confusion with use; dosage adjustment recommended.
- Elderly: Use with caution in elderly patients; dose adjustment recommended. Monitor for impaired cognitive and/or motor performance, confusion, and potential for falling.
- Females: Dosage adjustment is recommended for females; pharmacokinetic studies involving zolpidem showed a significant increase in maximum concentration and exposure in females compared to males at the same dose.
- Pediatric: When studied for the unapproved use of insomnia associated with ADHD in children, a higher incidence (~7%) of hallucinations was reported. In addition, sleep latency did not decrease compared to placebo.
Dosage form specific issues:
- Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer 's labeling.
Other warnings/precautions:
- Appropriate use: Symptomatic treatment of insomnia should be initiated only after careful evaluation of potential causes of sleep disturbance. Failure of sleep disturbance to resolve after 7 to 10 days may indicate the need for psychiatric and/or medical illness reevaluation.
- Rapid onset: Because of the rapid onset of action, administer immediately prior to bedtime, after the patient has gone to bed and is having difficulty falling asleep, or during the middle of the night when at least 4 hours are left before waking (Intermezzo).
- Withdrawal: Abrupt discontinuance or rapid dose decrease may lead to withdrawal symptoms.
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Adverse events were observed in some animal reproduction studies. Zolpidem crosses the placenta (Juric, 2009). Severe neonatal respiratory depression has been reported when zolpidem was used at the end of pregnancy, especially when used concurrently with other CNS depressants. Children born of mothers taking sedative/hypnotics may be at risk for withdrawal; neonatal flaccidity has been reported in infants following maternal use of sedative/hypnotics during pregnancy. Additional adverse effects to the fetus/newborn have been noted in some studies (Wang, 2010; Wikner, 2011).
Zolpidem, an imidazopyridine hypnotic that is structurally dissimilar to benzodiazepines, enhances the activity of the inhibitory neurotransmitter, Ž ³-aminobutyric acid (GABA), via selective agonism at the benzodiazepine-1 (BZ1) receptor; the result is increased chloride conductance, neuronal hyperpolarization, inhibition of the action potential, and a decrease in neuronal excitability leading to sedative and hypnotic effects. Because of its selectivity for the BZ1 receptor site over the BZ2 receptor site, zolpidem exhibits minimal anxiolytic, myorelaxant, and anticonvulsant properties (effects largely attributed to agonism at the BZ2 receptor site).
Cmax and AUC is increased by ~45% in females compared to male subjects
Immediate release and sublingual: Rapid
Extended release: Biphasic absorption; rapid initial absorption (similar to immediate release product); then provides extended concentrations in the plasma beyond 3 hours postadministration
Vd:
Children 2 to 6 years: 1.8 ‚ ± 0.8 L/kg (Blumer 2008)
Children >6 to 12 years: 2.2 ‚ ± 1.7 L/kg (Blumer 2008)
Adolescents: 1.2 ‚ ± 0.4 L/kg (Blumer 2008)
Adults: 0.54 L/kg (Holm 2000)
Hepatic methylation and hydroxylation via CYP3A4 (~60%), CYP2C9 (~22%), CYP1A2 (~14%), CYP2D6 (~3%), and CYP2C19 (~3%) to 3 inactive metabolites (Holm, 2000)
Urine (48% to 67%, primarily as metabolites); feces (29% to 42%, primarily as metabolites)
Clearance, apparent:
Children 2 to 6 years: 11.7 ‚ ± 7.9 mL/minute/kg (Blumer 2008)
Children >6 to 12 years: 9.7 ‚ ± 10.3 mL/minute/kg (Blumer 2008)
Adolescents: 4.8 ‚ ± 2 mL/minute/kg (Blumer 2008)
Adults: Intermezzo: Males: 4 mL/minute/kg; Females: 2.7 mL/minute/kg
Immediate release: 30 minutes
Children 2 to 6 years: Tablet (immediate release): 0.9 hours (Blumer 2008)
Children >6 to 12 years: Tablet (immediate release): 1.1 hours (Blumer 2008)
Adolescents: Tablet (immediate release): 1.3 hours (Blumer 2008)
Adults:
Immediate release: 1.6 hours; 2.2 hours with food
Extended release: 1.5 hours; 4 hours with food
Spray: ~0.9 hours
Sublingual tablet: Edluar: ~1.4 hours, ~1.8 hours with food; Intermezzo: 0.6 to 1.3 hours, ~3 hours with food
Immediate release: 6 to 8 hours
Children 2 to 6 years: Tablet (immediate release): 1.8 hours (Blumer 2008)
Children >6 years and Adolescents: Tablet (immediate release): 2.3 hours (Blumer 2008)
Adults:
Immediate release, Extended release: ~2.5 hours (range: 1.4 to 4.5 hours); Cirrhosis: Up to 9.9 hours; Elderly: Prolonged up to 32%
Spray: ~3 hours (range: 1.7 to 8.4)
Sublingual tablet (Edluar, Intermezzo): ~3 hours (range: 1.4 to 6.7 hours)
~93%
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience dizziness, fatigue, headache, nausea, or diarrhea. Have patient report immediately to prescriber dysphagia, shortness of breath, signs of depression (suicidal ideation, anxiety, emotional instability, or illogical thinking), confusion, hallucinations, change in balance, vision changes, memory impairment, or severe loss of strength and energy (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.