Adult Dosing

Short-term management of insomnia

zolpidem, Ambien, Ambien CR

• Immediate release
• Recommended dose: 10 mg PO qhs; Max: 10 mg/day
• Elderly/debilitated patients: 5 mg PO qhs

• Extended release
• Recommended dose: 12.5 mg PO qhs; Max: 12.5 mg/day
• Elderly/debilitated: 6.25 mg PO qhs

• Dose should not be administered with or immediately after meal
• Swallow them whole; do not crush, chew, or divide the tablet
• Recommended initial dose: Women - 5 mg PO qhs and Men - 5 or 10 mg PO qhs, Max: 10 mg/day
• Blood levels may remain high in morning following nighttime usage of 10 mg dose to impair activities that require alertness, including driving and is more prevalent in women because of their slower elimination compared with men

Edluar

• Sublingual
• Recommended dose: 10 mg PO qhs; Max: 10 mg/day
• Elderly/debilitated patients: 5 mg PO qhs

Note:

• Should not be given with or immediately after meal
• Tablet should be placed under the tongue, where it will disintegrate; do not swallow or take with water
• Recommended initial dose: Women - 5 mg PO qhs and Men - 5 or 10 mg PO qhs, Max: 10 mg/day
• Blood levels may remain high in morning following nighttime usage of 10 mg dose to impair activities that require alertness, including driving and is more prevalent in women because of their slower elimination compared with men

Intermezzo

• Sublingual
• Men: 3.5 mg/night PRN; Max: 1 dose/night
• Women: 1.75/night PRN; Max: 1 dose/night
• Recommended dose for men and women who are taking concomitant CNS depressants and in patients >65 years is 1.75 mg/night PRN

Note:

• Indicated for middle-of-the-night waking with difficulty returning to sleep
• Admister only if >4 hours before planned time of waking
• Reevaluate if insomnia persists after 7-10 days of treatment

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Short-term treatment of insomnia characterized by difficulties with sleep initiation (immediate release, sublingual tablets)
• Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (extended release)

• Hypersensitivity to any of the ingredients of the product
• Alcohol use

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments; monitor patients carefully

Hepatic Dose Adjustment

zolpidem, Edluar, Ambien

• Hepatic impairment: 5 mg PO qhs

Ambien CR

• Hepatic impairment: 6.25 mg PO qhs

Intermezzo

• Hepatic impairment: 1.75 mg/night PRN

See Supplemental Patient Information

• Treatment of insomnia should be started after careful evaluation of the patient. If insomnia persists after 7 to 10 days of treatment, reevaluate the patient for a primary psychiatric and/or medical illness
• Angioedema involving the tongue, glottis and larynx have been reported after taking the first or subsequent doses of zolpidem, which may lead to airway obstruction that could be fatal. Additional symptoms such as dyspnea, nausea, throat closing, and vomiting that suggest anaphylaxis have been reported in some patients receiving zolpidem. Do not re-challenge with the drug if such reactions develop after treatment with zolpidem
• Abnormal thinking and behavior changes including decreased inhibition, visual and auditory hallucinations, bizarre behavior, agitation, depersonalization, and sleep-driving have been reported with the use of zolpidem. Avoid using alcohol and other CNS depressants concomitantly with zolpidem, as the risk of developing such behaviors is increased
• In primarily depressed patients, exacerbation of depression including suicidal thoughts and actions has been reported during therapy. Emergence of any new behavioral sign or symptom of concern requires careful evaluation
• Rapid dose reduction or abrupt discontinuation of therapy may lead to signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs
• Advise patients to take the tablet immediately prior to going to bed, and not to engage in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a vehicle after ingesting the drug
• Zolpidem should be given in lower doses in elderly/debilitated patients due to the risk of impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to the drug
• Use cautiously in patients with diseases or conditions that could affect metabolism or hemodynamic responses, compromised respiratory function, sleep apnea syndrome, myasthenia gravis, and hepatic impairment
• Use with caution in patients exhibiting signs or symptoms of depression. The lowest possible effective dose should be prescribed

Cautions: Use cautiously in

• History of alcohol or drug abuse
• Psychiatric disorder

Supplemental Patient Information

• Advice patients about the risk of sleep-driving and other complex behaviors associated with zolpidem use; inform them to report any such events to the physician
• Instruct patients not to drive or perform any hazardous activities after taking zolpidem until they feel fully awake
• Advise patients not to drink alcohol during therapy because of the potentially additive effects

Pregnancy Category:C

Breastfeeding: Zolpidem is excreted in breastmilk in small amounts; however, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 12 April 2011). This drug is considered compatible with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 12 April 2011). Manufacturer advises caution.

• CV: Palpitations
• CNS: Headache, drowsiness, dizziness, lethargy, lightheadedness, somnolence
• PSYCHIATRY: Abnormal thinking, behavior changes, complex sleep-related behaviors, worsening depression, suicidal ideation, aggressive behavior, amnesia, hallucinations, depression, drugged feeling
• GI: Diarrhea, dry mouth, constipation
• DERM: Rash
• EENT: Sinusitis, pharyngitis
• MUSC: Back pain, myalgia
• MISC: Withdrawal effects on abrupt discontinuation, influenza-like symptoms
• HYPERSENSITIVITY: Serious anaphylactic/anaphylactoid reactions, allergic reactions

• GABA agonist; interacts with a GABA-BZ receptor complex and binds preferentially to BZ1 receptor with a high affinity ratio of the alpha1/alpha5 subunits
• Rapidly absorbed following oral administration
• Metabolism: Converted to inactive metabolites in the liver
• Excreted primarily in urine
• Half-life
• Immediate release: 2.6 hrs (5 mg); 2.5 hrs (10 mg)
• Extended release: 2.8 hrs
• Sublingual: 2.85 hrs (5 mg); 2.65 hrs (10mg)

US Trade Name(s)

• Ambien
• Ambien CR
• Edluar
• Intermezzo
• Zolpimist

US Availability

zolpidem (generic)

• TABS: 5, 10 mg
• ETABS: 6.25, 12.5 mg

Ambien

• TABS: 5, 10 mg

Ambien CR

• ETABS: 6.25, 12.5 mg

Edluar

• SL TABS: 5, 10 mg

Intermezzo

• SL TABS: 1.75, 3.5 mg

Zolpimist

• ORAL SPRAY: 5 mg/spray

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Stilnoct

UK Availability

zolpidem (generic)

• TABS: 5, 10 mg

Stilnoct

• TABS: 5, 10 mg

Australian Trade Name(s)

• Dormizol
• Somidem
• Stildem
• Stilnox
• Stilnox-CR
• Zolpibell

Australian Availability

zolpidem (generic)

• TABS: 10 mg

Dormizol, Somidem, Stildem, Stilnox, Zolpibell

• TABS: 10 mg

Stilnox-CR

• ETABS: 6.25, 12.5 mg

[Outline]

Psychiatric

Anxiolytics/Sedatives/Hypnotics

Miscellaneous Agents

Neurologic

Anxiolytics/Sedatives/Hypnotics

Miscellaneous Agents

Pricing data from www.DrugStore.com in U.S.A.

• Ambien CR 6.25 MG TBCR [Bottle] (SANOFI-AVENTIS U.S.)
  30 mg = $193.99
  90 mg = $555.97
• Edluar 10 MG SUBL [Box] (MEDA PHARMACEUTICALS)
  30 mg = $179.99
  90 mg = $525.99
• Ambien CR 12.5 MG TBCR [Bottle] (SANOFI-AVENTIS U.S.)
  30 mg = $190.99
  90 mg = $549.97
• Edluar 5 MG SUBL [Box] (MEDA PHARMACEUTICALS)
  30 mg = $179.99
  90 mg = $519.96
• Ambien 5 MG TABS [Bottle] (SANOFI-AVENTIS U.S.)
  30 mg = $203.64
  90 mg = $582.16
• Ambien 10 MG TABS [Bottle] (SANOFI-AVENTIS U.S.)
  30 mg = $209.98
  90 mg = $599.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Ambien (ZOLPIDEM 10 mg) (Physicians Total Care, Inc.)
• Ambien (ZOLPIDEM 5 mg) (Physicians Total Care, Inc.)
• Ambien (zolpidem 10 mg) (Rebel Distributors Corp.)
• Ambien (zolpidem 5 mg) (Rebel Distributors Corp.)
• Ambien 10 MG Oral Tablet (Caremark L.L.C.)
• Ambien 10 MG Oral Tablet (sanofi-aventis U.S. LLC)
• Ambien 5 MG Oral Tablet (sanofi-aventis U.S. LLC)
• Ambien CR (zolpidem 12.5 mg) (Rebel Distributors Corp.)
• Ambien CR (zolpidem 6.25 mg) (Rebel Distributors Corp.)
• Ambien CR 12.5 MG Extended Release Tablet (Physicians Total Care, Inc.)
• Ambien CR 12.5 MG Extended Release Tablet (sanofi-aventis U.S. LLC)
• Ambien CR 6.25 MG Extended Release Tablet (Physicians Total Care, Inc.)
• Ambien CR 6.25 MG Extended Release Tablet (sanofi-aventis U.S. LLC)
• Edluar 10 MG Sublingual Tablet (Meda Pharmaceuticals Inc.)
• Edluar 10 MG Sublingual Tablet (Meda Pharmaceuticals)
• Edluar 5 MG Sublingual Tablet (Meda Pharmaceuticals Inc.)
• Zolpidem tartrate 10 MG Oral Tablet (American Health Packaging)
• Zolpidem tartrate 10 MG Oral Tablet (Apotex Corp.)
• Zolpidem tartrate 10 MG Oral Tablet (Aurobindo Pharma Limited)
• Zolpidem tartrate 10 MG Oral Tablet (Caraco Pharmaceutical Laboratories, Ltd.)
• Zolpidem tartrate 10 MG Oral Tablet (Caremark L.L.C.)
• Zolpidem tartrate 10 MG Oral Tablet (Dr. Reddy's Laboratories Inc. )
• Zolpidem tartrate 10 MG Oral Tablet (InvaGen Pharmaceuticals Inc.,)
• Zolpidem tartrate 10 MG Oral Tablet (Major Pharmaceuticals)
• Zolpidem tartrate 10 MG Oral Tablet (Mutual Pharmaceutical Company, Inc.)
• Zolpidem tartrate 10 MG Oral Tablet (Mylan Pharmaceuticals Inc.)
• Zolpidem tartrate 10 MG Oral Tablet (Physicians Total Care, Inc.)
• Zolpidem tartrate 10 MG Oral Tablet (Qualitest Pharmaceuticals)
• Zolpidem tartrate 10 MG Oral Tablet (Rebel Distributors Corp.)
• Zolpidem tartrate 10 MG Oral Tablet (Sandoz Inc.)
• Zolpidem tartrate 10 MG Oral Tablet (Synthon Pharmaceuticals, Inc.)
• Zolpidem tartrate 10 MG Oral Tablet (TEVA Pharmaceuticals USA Inc)
• Zolpidem tartrate 10 MG Oral Tablet (Torrent Pharmaceuticals Limited)
• Zolpidem tartrate 10 MG Oral Tablet (Watson Laboratories)
• Zolpidem tartrate 10 MG Oral Tablet (West-ward Pharmaceutical Corp.)
• Zolpidem tartrate 10 MG Oral Tablet (Wockhardt Ltd.)
• Zolpidem tartrate 10 MG Oral Tablet (Yung Shin Pharmaceutical Industries, Co., LTD.)
• Zolpidem tartrate 5 MG Oral Tablet (American Health Packaging)
• Zolpidem tartrate 5 MG Oral Tablet (Apotex Corp.)
• Zolpidem tartrate 5 MG Oral Tablet (Aurobindo Pharma Limited)
• Zolpidem tartrate 5 MG Oral Tablet (Caraco Pharmaceutical Laboratories, Ltd.)
• Zolpidem tartrate 5 MG Oral Tablet (Caremark L.L.C.)
• Zolpidem tartrate 5 MG Oral Tablet (Dr. Reddy's Laboratories Inc. )
• Zolpidem tartrate 5 MG Oral Tablet (InvaGen Pharmaceuticals Inc.,)
• Zolpidem tartrate 5 MG Oral Tablet (Major Pharmaceuticals)
• Zolpidem tartrate 5 MG Oral Tablet (Mutual Pharmaceutical Company, Inc.)
• Zolpidem tartrate 5 MG Oral Tablet (Mylan Pharmaceuticals Inc.)
• Zolpidem tartrate 5 MG Oral Tablet (Physicians Total Care, Inc.)
• Zolpidem tartrate 5 MG Oral Tablet (Qualitest Pharmaceuticals)
• Zolpidem tartrate 5 MG Oral Tablet (Rebel Distributors Corp.)
• Zolpidem tartrate 5 MG Oral Tablet (Sandoz Inc.)
• Zolpidem tartrate 5 MG Oral Tablet (Synthon Pharmaceuticals, Inc.)
• Zolpidem tartrate 5 MG Oral Tablet (TEVA Pharmaceuticals USA Inc)
• Zolpidem tartrate 5 MG Oral Tablet (Torrent Pharmaceuticals Limited)
• Zolpidem tartrate 5 MG Oral Tablet (Watson Laboratories)
• Zolpidem tartrate 5 MG Oral Tablet (West-ward Pharmaceutical Corp.)
• Zolpidem tartrate 5 MG Oral Tablet (Wockhardt Ltd.)
• Zolpidem tartrate 5 MG Oral Tablet (Yung Shin Pharmaceutical Industries, Co., LTD.)