Zolpidem Side Effects

It is possible that some side effects of zolpidem may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to zolpidem: spray, tablet

As well as its needed effects, zolpidem may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking zolpidem, check with your doctor immediately:

Less common
  • Clumsiness or unsteadiness
  • confusion
  • depression
Rare
  • Difficulty with breathing
  • dizziness, lightheadedness, or fainting
  • falling
  • fast heartbeat
  • seeing, hearing, or feeling things that are not there
  • skin rash
  • swelling of the face
  • trouble sleeping
  • unusual excitement, nervousness, or irritability
  • wheezing

Some zolpidem side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Sleepiness or unusual drowsiness
Less common
  • Abdominal or stomach pain
  • abnormal or decreased touch sensation
  • abnormal sensation of movement
  • appetite disorder
  • balance disorder
  • binge eating
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in hearing
  • chest discomfort
  • chills
  • confusion about identity, place, and time
  • constipation
  • continuous ringing, buzzing, or other unexplained noise in the ears
  • daytime drowsiness
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with moving
  • difficulty with swallowing
  • discouragement
  • double vision
  • drugged feeling
  • dry mouth
  • earache
  • eye redness
  • false or unusual sense of well-being
  • feeling of unreality
  • feeling sad or empty
  • frequent bowel movements
  • frequent urge to urinate
  • headache
  • hearing loss
  • heartburn
  • hives or welts
  • itching ears
  • joint pain
  • lack of appetite
  • lack of feeling or emotion
  • lack or loss of self-control
  • lack or loss of strength
  • longer or heavier menstrual periods
  • loss of balance
  • loss of interest or pleasure
  • memory problems
  • mood swings
  • muscle aches, cramping, pain, or stiffness
  • nausea
  • nightmares or unusual dreams
  • redness of the skin
  • redness or soreness of the throat
  • sense of detachment from self or body
  • slowing of mental and physical activity
  • sneezing
  • stuffy or runny nose
  • swollen joints
  • tiredness
  • trouble concentrating
  • vision changes
  • vomiting

For Healthcare Professionals

Applies to zolpidem: oral spray, oral tablet, oral tablet extended release, sublingual tablet

General

In general, zolpidem is well-tolerated and causes little or no residual daytime effects in most young adult volunteers. Additionally, zolpidem does not significantly alter sleep architecture at recommended doses.

General side effects including fatigue have been reported.[Ref]

Nervous system

Nervous system side effects most frequently have included visual disturbances, ataxia, and dizziness. Headache, drugged feeling, confusion, anterograde amnesia, excessive sedation, lightheadedness, delirium, nightmares, hallucinations, nervousness, and agitation have also been reported.[Ref]

Chronic use in high doses and subsequent withdrawal may induce grand mal seizures. Cases of falls have been reported in elderly patients.[Ref]

Hypersensitivity

Hypersensitivity side effects including rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.

Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with zolpidem should not be rechallenged with the drug.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, dyspepsia, anorexia, and diarrhea. In clinical studies on the sublingual tablet, one patient developed transient sublingual erythema and another patient developed transient paresthesia of the tongue.[Ref]

Other

Other side effects including tolerance to the pharmacologic effects of zolpidem have been reported rarely. Withdrawal symptoms after either abrupt cessation or fast tapering may occur. Withdrawal symptoms may include agitation, restlessness, anxiety, depression, insomnia, tremor, nausea, abdominal discomfort, and sweating.

Other side effects associated with the oral spray have included dry mouth.

A case of sleep driving has also been reported.[Ref]

Psychiatric

Psychiatric side effects including cases of psychotic reactions have been reported in association with zolpidem therapy.[Ref]

Respiratory

Zolpidem-induced respiratory depression may be responsive to flumazenil. Zolpidem-induced respiratory depression is generally not clinically significant at the usual hypnotic doses even in patients with impaired respiratory function.

One study has suggested that zolpidem doses of 20 mg (twice the usual dose) may cause apneic episodes in patients with obstructive sleep apnea.[Ref]

Respiratory side effects have included respiratory depression which may occur at high doses. Upper or lower respiratory tract infection and rhinitis have also been reported.[Ref]

Cardiovascular

Cardiovascular side effects including palpitations have been reported in patients taking zolpidem.[Ref]

Genitourinary

Genitourinary side effects including urinary incontinence and urinary tract infection have been reported.[Ref]

Hepatic

Hepatic side effects include one case of hepatotoxicity associated with zolpidem given alone at therapeutic doses.[Ref]

Immunologic

Immunologic side effects including infection have been reported infrequently.

Musculoskeletal

Musculoskeletal side effects including arthralgia and myalgia have been reported.

References

1. Langtry HD, Benfield P "Zolpidem. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential." Drugs 40 (1990): 291-313

2. Sauvanet JP, Maarek L, Roger M, Renaudin J, Louvel E, Orofiamma B. Open long-term trials with zolpidem in insomnia. In: Sauvanet JP, Langer SZ, Morselli PL, eds. "Imidazopyridines in Sleep Disorders: a Novel Experimental and Therapeutic Approach." New York, NY: Raven Press (1988): 339-49

3. Morselli PL, Larribaud J, Guillet PH, et al.. Daytime residual effects of zolpidem: a review of available data. In: Sauvanet JP, Langer SZ, Morselli PL, eds. "Imidazopyridines in Sleep Disorders: a Novel Experimental and Therapeutic Approach." New York, NY: Raven Press (1988): 183-91

4. Canaday BR "Amnesia possibly associated with zolpidem administration." Pharmacotherapy 16 (1996): 687-9

5. Roger M, Dallot JY, Salmon O, et al.. Hypnotic effect of zolpidem in geriatric patients: a dose-finding study. In: Sauvanet JP, Langer SZ, Morselli PL, eds. "Imidazopyridines in Sleep Disorders: a Novel Experimental and Therapeutic Approach." New York, NY: Raven Press (1988): 279-87

6. Pies RW "Dose-related sensory distortions with zolpidem." J Clin Psychiatry 56 (1995): 35-6

7. Scharf MB, Kaffeman M, Rodgers L, Segal J. Single dose tolerance study of zolpidem. In: Sauvanet JP, Langer SZ, Morselli PL, eds. "Imidazopyridines in Sleep Disorders: a Novel Experimental and Therapeutic Approach." New York, NY: Raven Press (1988): 175-81

8. Palminteri R, Narbonne G. Safety profile of zolpidem. In: Sauvanet JP, Langer SZ, Morselli PL, eds. "Imidazopyridines in Sleep Disorders: a Novel Experimental and Therapeutic Approach." New York, NY: Raven Press (1988): 351-61

9. Emeriau JP, Descamps A, Dechelotte P, Poch B, Harribey B, Alla P, Colle M. Zolpidem and flunitrazepam: a multicenter trial in elderly hospitalized patients. In: Sauvanet JP, Langer SZ, Morselli PL, eds. "Imidazopyridines in Sleep Disorders: a Novel Experimental and Therapeutic Approach." New York, NY: Raven Press (1988): 317-26

10. Vanpuijenbroek EP, Egberts ACG, Krom HJ "Visual hallucinations and amnesia associated with the use of zolpidem." Int J Clin Pharmacol Ther 34 (1996): 318

11. "Product Information. Edluar (zolpidem)." Meda Pharmaceuticals, Somerset, NJ.

12. Abramowicz M, Rizack MA, Hirsch J, et al "Zolpidem for insomnia." Med Lett Drugs Ther 35 (1993): 35-6

13. Sanchez LG, Sanchez JM, Moreno JL "Dependence and tolerence with zolpidem." Am J Health Syst Pharm 53 (1996): 2638

14. Doane JA, Dalpiaz AS "Zolpidem-induced sleep-driving." Am J Med 121 (2008): e5

15. Cavallaro R, Regazzetti MG, Covelli G, Smeraldi E "Tolerance and withdrawal with zolpidem." Lancet 342 (1993): 374-5

16. Gericke CA, Ludolph AC "Chronic abuse of zolpidem." JAMA 272 (1994): 1721-2

17. Ansseau M, Pitchot W, Hansenne M, Gonzalez Moreno A "Psychotic reactions to zolpidem." Lancet 339 (1992): 809

18. Brodeur MR, Stirling AL "Delirium associated with zolpidem." Ann Pharmacother 35 (2001): 1562-4

19. de Haas S, Dingemanse J, Hoever P, Cohen A, van Gerven J "Pseudohallucinations After Zolpidem Intake: A Case Report." J Clin Psychopharmacol 27 (2007): 728-730

20. Cirignotta F, Mondini S, Zucconi M, Gerardi R, Farolfi A, Lugaresi E. Controlled polysomnographic study of the effects of benzodiazepine and non-benzodiazepine hypnotics (zolpidem) in obstructive sleep apnea patients: preliminary results. In: Sauvanet JP, "Imidazopyridines in Sleep Disorders: a Novel Experimental and Therapeutic Approach." New York, NY: Raven Press (1988): 297-304

21. Murciano D, Aubier M, Palacios S, Parients R "Comparison of zolpidem (Z), triazolam (T), and flunitrazepam (F) effects on arterial blood gases and control of breathing in patients with severe chronic obstructive pulmonary disease (COPD)." Chest 97 Suppl (1990): s51-2

22. Lheureux P, Debailleul G, De Witte O, Askenasi R "Zolpidem intoxication mimicking narcotic overdose: response to flumazenil." Hum Exp Toxicol 9 (1990): 105-7

23. "Product Information. Ambien (zolpidem)." Searle, Skokie, IL.

24. Karsenti D, Blanc P, Bacq Y, Metman EH "Hepatotoxicity associated with zolpidem treatment." Br Med J 318 (1999): 1179

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