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Zolpidem

Pronunciation

Pronunciation

(zole PI dem)

Index Terms

  • Zolpidem Tartrate

Dosage Forms

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

Brand Names: U.S.

  • Ambien
  • Ambien CR
  • Edluar
  • Intermezzo
  • Zolpimist [DSC]

Pharmacologic Category

  • Hypnotic, Miscellaneous

Pharmacology

Zolpidem, an imidazopyridine hypnotic that is structurally dissimilar to benzodiazepines, enhances the activity of the inhibitory neurotransmitter, γ-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).

Absorption

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

Distribution

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)

Metabolism

Hepatic methylation and hydroxylation via CYP3A4 (~60%), CYP2C9 (~22%), CYP1A2 (~14%), CYP2D6 (~3%), and CYP2C19 (~3%) to 3 inactive metabolites (Holm, 2000)

Excretion

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

Onset of Action

Immediate release: 30 minutes

Time to Peak

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

Duration of Action

Immediate release: 6 to 8 hours

Half-Life Elimination

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)

Protein Binding

~93%

Special Populations: Hepatic Function Impairment

Cmax and AUC were found to be 2 and 5 times higher, respectively, in hepatically compromised patients.

Special Populations: Elderly

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.

Special Populations: Gender

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.

Use: Labeled Indications

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)

Contraindications

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

Dosing: Adult

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

Dosing: Geriatric

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

Dosing: Renal Impairment

No dosage adjustment necessary.

Hemodialysis: Not dialyzable

Dosing: Hepatic Impairment

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.

Sublinox [Canadian product]:

Mild-to-moderate impairment: 5 mg immediately before bedtime

Severe impairment: Use is contraindicated.

Administration

Oral: 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.

Dietary Considerations

Do not administer with or immediately after a meal (may delay onset).

Storage

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.

Drug Interactions

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

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Ciprofloxacin (Systemic): May increase the serum concentration of Zolpidem. 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 Zolpidem. Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Zolpidem. Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Zolpidem. Monitor therapy

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 (Systemic): 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: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Itraconazole: May increase the serum concentration of Zolpidem. Monitor therapy

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

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Methotrimeprazine: May enhance the CNS depressant effect of CNS Depressants. CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. 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

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. 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

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 John's 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: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. 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

Test Interactions

Increased aminotransferase [ALT/AST], bilirubin (S); decreased RAI uptake

Adverse Reactions

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

Warnings/Precautions

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.

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.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis.

• Respiratory disease: Use with caution in patients with respiratory compromise, COPD, or sleep apnea.

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.

Monitoring Parameters

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.

Pregnancy Risk Factor

C

Pregnancy Considerations

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).

Patient Education

• 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 signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), difficulty swallowing, difficulty breathing, slow breathing, shallow breathing, confusion, behavioral changes, 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.

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