Monday, September 23, 2013

Zolpidem

Today's med: Zolpidem (zole PI dem) (brand name: Ambien, Edluar, Intermezzo, Zolpimist)

Drug Class: gamma-Aminobutyric Acid-ergic Agonist (Hypnotic, Miscellaneous)

Other Drugs in this class: Baclofen,Zolpidem tartrate 

Indications: 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 middle-of-the-night insomnia with ≥4 hours of sleep time remaining.
Sublinox™ (Canadian availability; not available in U.S.): 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

Adverse Effects: >10%: Central nervous system: Headache (3% to 19%), somnolence (6% to 15%), dizziness (1% to 12%); 1% to 10%: Cardiovascular: Blood pressure increased, chest discomfort/pain, palpitation; Central nervous system: Abnormal dreams, anxiety, apathy, amnesia, ataxia, attention disturbance, body temperature increased, burning sensation, confusion, depersonalization, depression, disinhibition, disorientation, drowsiness, drugged feeling, euphoria, fatigue, fever, hallucinations, hypoesthesia, insomnia, lethargy, lightheadedness, memory disorder, mood swings, sleep disorder, stress; Dermatologic: Rash, urticaria, wrinkling; Endocrine & metabolic: Menorrhagia; Gastrointestinal: Abdominal discomfort, abdominal pain, abdominal tenderness, appetite disorder, constipation, diarrhea, dyspepsia, flatulence, gastroenteritis, gastroesophageal reflux, hiccup, nausea, vomiting, xerostomia; Genitourinary: Urinary tract infection, vulvovaginal dryness; Neuromuscular & skeletal: Arthralgia, back pain, balance disorder, involuntary muscle contractions, myalgia, neck pain, paresthesia, psychomotor retardation, tremor, weakness; Ocular: Asthenopia, blurred vision, depth perception altered, diplopia, red eye, visual disturbance; Otic: Labyrinthitis, tinnitus, vertigo; Renal: Dysuria, Respiratory: Pharyngitis, sinusitis, throat irritation, upper respiratory tract infection, Miscellaneous: Allergy, binge eating, flu-like syndrome
<1% (Limited to important or life-threatening): Agitation, anaphylaxis, anemia, angioedema, cerebrovascular disorder, cognition decreased, complex sleep-related behavior (sleep-driving, cooking or eating food, making phone calls), concentrating difficulty, cystitis, diaphoresis, dysphagia, dyspnea, edema, emotional lability, falling, hepatic function abnormalities, hyperglycemia, hyper-/hypotension, illusion, leukopenia, lymphadenopathy, migraine, orthostatic hypotension, paresthesia of the tongue (sublingual tablets), pruritus, renal failure (acute), scleritis, somnambulism (sleepwalking), speech disorder, stupor, sublingual erythema (sublingual tablets), syncope, tachycardia, thrombosis, urinary incontinence, vaginitis
**NOTE: Zolpidem is known to inhibit REM sleep.
Standard Dosing:  Oral: Adults: 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 5-10 mg (males) immediately before bedtime; maximum dose: 10 mg daily
Extended release tablet: 6.25 mg (females) or 6.25-12.5 mg (males) immediately before bedtime
Sublingual tablet:
Edluar™: 5 mg (females) or 5-10 mg (males) immediately before bedtime; maximum dose: 10 mg daily
Sublinox™ (Canadian availability; not available in U.S.): 10 mg immediately before bedtime; maximum dose: 10 mg daily
Intermezzo®: Note: Take only if ≥4 hours left before waking
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.

Ingest immediately before bedtime due to rapid onset of action. Regardless of dosage form, do not administer with or immediately after a meal. 
Ambien CR® tablets should be swallowed whole; do not divide, crush, or chew. Edluar™, Intermezzo®, or Sublinox™ (Canadian availability; not available in U.S.) sublingual tablets should be placed under the tongue and allowed to disintegrate; do not swallow or administer with water.  Zolpimist® oral spray should be sprayed directly into the mouth over the tongue. Prior to initial use, pump should be primed by spraying 5 times. If pump is not used for at least 14 days, re-prime pump with 1 spray.

A total of 691 drugs (3835 brand and generic names) are known to interact with zolpidem.
  • 7 major drug interactions (28 brand and generic names)
  • 644 moderate drug interactions (3669 brand and generic names)
  • 40 minor drug interactions (138 brand and generic names)
Show all medications in the database that may interact with zolpidem.
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
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy

ZZZZZZZZZZZZolpidem!! (get your Z's)

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