Sleep Medications

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Sleep disturbances are common among fibromyalgia patients. As many as 90% of all fibromyalgia patients experience some form of sleep disruption, including insomnia (difficulty initiating or maintaining sleep), non-restorative sleep (i.e., poor quality sleep), as well as particular brain wave abnormalities during sleep, sleep apnea, restless leg syndrome, and bruxism (teeth grinding) (Roizenblatt et al., 2011; Spaeth et al., 2011). In addition to common over-the-counter sleep aids, such as Unisom or Nytol, a variety of prescription sleep medications are available for use in treating sleep disturbances. Common sleep medications include Lunesta, Rozerem, Sonata, Ambien, and Imovane. The following article provides a brief overview of the main prescription sleep medications available, as well as an overarching literature summary of their use in fibromyalgia and related conditions.

Lunesta

Lunesta (eszopiclone) is a prescription sleep medication in the drug class known as hypnotics. It is used to help treat insomnia by slowing activity in the brain in order to facilitate sleep. Lunesta is taken orally as a tablet, generally at bedtime or after a failed attempt to fall asleep. It should not be taken after a heavy meal, especially one containing a lot of fat, as high fat foods can interfere with Lunesta’s ability to work effectively. Lunesta results in noticeable sedation quickly after it is ingested, and sedation lasts for approximately eight hours. Therefore, Lunesta should always be taken at or around bedtime and only when a full eight hours are available to devote to sleep. Failure to go to bed after taking Lunesta can result in marked dizziness, lightheadedness, hallucinations, and memory problems. The exact dose required to effectively induce and maintain sleep will vary between individuals, therefore the dosage of Lunesta may need to be adjusted during the first week of therapy in order to determine what dose is most effective while at the same time, minimizing daytime sleepiness and other potential side effects.

Common side effects of Lunesta include dependency, daytime drowsiness, sleep walking, and changes in mental health status (such as aggression, hallucinations, depression, suicidal thoughts, and confusion). Lunesta can also interact negatively with a number of other prescription medications, including antidepressants; medications used to treat fungal infections; antihistamines; certain antibiotics; certain drugs used to treat anxiety and seizures; sedative medications; other sleeping pills; and certain drugs used to treat HIV.

Rozerem

Rozerem (ramelteon) is prescribed for individuals with a condition known as sleep-onset insomnia, or difficulty falling asleep. It is in a class of drugs known as melatonin receptor agonists and works in a manner similar to melatonin, the hormone involved in sleep-wake cycle regulation. Rozerem is generally taken as a tablet, approximately 30 minutes before bedtime. It should not be taken with food, nor should the tablet be crushed or chewed. Like Lunesta, Rozerem begins to exert its effects quickly, and they last for up to eight hours. Therefore, Rozerem should be taken immediately before bed and should only be taken when a full eight hours can be devoted to sleep. It may take up to ten days before the full effects of Rozerem on insomnia are seen.

Rozerem has the potential to interact negatively with a number of other medications, including: medications used to treat fungal infections; certain antibiotics; certain antidepressants; medications used to treat heartburn (such as Tagamet); medications used to treat HIV; medicines used to treat anxiety, pain, and seizures; sedatives; other sleeping aids; and various tranquilizer medications. Other medications also have the potential to interact with Rozerem, including various vitamins and nutritional supplements, therefore individuals who are considering taking Rozerem should also inform their doctor about every medication (both prescription and over-the-counter) they are taking.

Side effects of Rozerem include daytime sleepiness, sleepwalking, and drastic changes in mental status. In addition, individuals taking Rozerem should avoid using alcohol due to the fact that alcohol can intensity Rozerem’s sedative effects. Furthermore, individuals with COPD, a history of suicide attempts, sleep apnea, respiratory problems, depression, mental illness, or liver disease should not take Rozerem.

Sonata

Sonata (zaleplon) is also used to help treat insomnia, and works like Lunesta to slow brain activity and promote sleep. In general, sleep improvements will be noticeable after approximately one week of treatment with Sonata. Sonata is taken in a capsule form either at bedtime, or after an unsuccessful attempt to fall asleep. Like Lunesta, Sonata should not be taken with a heavy, fat-filled meal, as doing so may compromise its effectiveness. Sonata exerts its effects on the brain quickly, therefore individuals who take it should go to bed immediately to avoid unwanted side effects, such as dizziness, lightheadedness, memory impairment, coordination problems, and hallucinations. Other side effects associated with Sonata include dependency, as well as withdrawal after abrupt discontinuation of use. Sleepwalking and changes in mental health status are also a possibility, as are numbness and tingling in the hands and feet, headache, appetite changes, vision problems, eye pain, impaired sense of smell, and painful menstruation. Allergic reactions may also occur, and are characterized by rash, itching, hives, facial and throat swelling, breathing difficulties, and voice changes.

Like other prescription sleep medications, Sonata has the potential to interact negatively with antihistamines such as diphenhydramine (the active ingredient in Benadryl); barbiturates; medications used to treat heartburn (e.g., Tagamet); certain cough and cold medications; the antibiotic erythromycin; the tricyclic antidepressant imipramine (Tofranil) and other antidepressant medications; certain anti-fungal medications; medications used to treat seizures; various pain relievers; sedatives; other sleeping medications; and certain tranquilizers. Furthermore, individuals with a history of heavy alcohol use or dependency, or those with a history of suicidal thoughts or behaviors, should use Sonata with caution. In addition, individuals with lung disease, breathing problems, kidney disease, or liver disease should also discuss their options with their physician.

Ambien

Ambien (zolpidem) is a drug in the class known as sedative-hypnotics, and is used to treat all forms of insomnia (falling asleep and staying asleep). Similar to Lunesta and Sonata, Ambien works by calming the activity in the brain to promote sleep. Ambien is available in several forms, including a tablet, an extended-release tablet, and a tablet that is placed under the tongue (sublingual) where it dissolves. In addition, Ambien is also available as an oral spray that is sprayed into the mouth or onto the tongue. The extended release-tablets should not be broken or chewed, and the sublingual tablet should not be swallowed or taken with water. Specific instructions for taking the oral spray are provided with the product.

Like other prescription sleep aides, Ambien should be taken immediately before bed, without food, and only when a full eight hours can be devoted to sleep. Additionally, sleep problems will also generally improve within seven to 10 days after starting therapy with Ambien. It is important to note that use of Ambien for more than two weeks can result in dependences, as well as decreased effectiveness of the medication. Furthermore, sudden discontinuation of the drug can result in symptoms of withdrawal, including shakiness, lightheadedness, stomach and muscle cramps, nausea and vomiting, uncontrollable crying, panic attacks, sleeping difficulties, uncontrolled shaking, and seizures, among others. Individuals with a history of heavy alcohol use or dependency, illicit drug use, or overuse of prescription medications should inform their doctor of those prior behaviors. In addition, individuals with mental illness, a history of suicide attempts or thoughts, heavy snoring, sleep apnea, breathing problems (including asthma), or a history of kidney or liver disease should discuss their options with their physician.

Side effects of Ambien are similar to those of other prescription sleep aids, including daytime drowsiness (especially in elderly individuals), sleepwalking, and changes in mental status and behavior. Other side effects include headache, ‘drugged feeling,’ unsteady walking, difficulty maintaining balance, constipation, diarrhea, heartburn, stomach upset, appetite changes, numbness or tingling in the hands and feet, strange dreams, burning or tingling of the tongue (with sublingual tablet use), dry mouth or throat, eye irritation, muscle aches, joint and neck pain, and heavy bleeding during menstruation. Signs of a potentially serious allergic reaction to Ambien include hives, itching, facial and throat swelling, breathing difficulty, chest pain, racing heartbeat, and vision disturbances.

Potential drug interactions include antidepressants, especially Tofranil and Zoloft; anti-fungal medications; anti-anxiety medications; medications used to treat allergies and colds; anti-seizure medications; pain relievers; sedatives; other sleeping pills; and certain tranquilizers.

Imovane

Imovane (zopiclone) is a prescription sleep aid very similar to Ambien, however it is not available for sale in the United States; it is currently available in Canada. It belongs to the class of drugs known as central nervous system depressants, and is used to help initiate sleep, maintain sleep, and reduce night time awakenings. Treatment with Imovane should not exceed seven to 10 days in duration, and like other prescription sleep aids, Imovane should be taken just prior to bed when the patient has a full night to devote to sleep.

Side effects of Imovane include daytime sleepiness, dizziness, confusion, impaired memory, drunken feeling, nightmares, agitation hostility, depression, impaired coordination, speech disruption, bitter taste in the mouth, dry mouth, constipation, appetite changes, allergic reaction, abnormal laboratory findings with routine blood testing, heart palpitations, and symptoms associated with withdrawal upon abrupt discontinuation of treatment.

Similar to the drugs described above, Imovane may interact negatively with alcohol, other central nervous system depressant medications, antihistamines, anti-seizure drugs, narcotic pain relievers, antipsychotic medications, hypnotic medications, sedatives, and certain antidepressant drugs.

Research Related to Sleep Medications and Fibromyalgia

An Internet-based survey was administered to more than 2,500 fibromyalgia patients in October of 2005 to assess a number of items, including demographic information, symptoms, functioning, aggravating factors for fibromyalgia symptoms, triggering events, use of healthcare resources, management and coping strategies, and sleep medications use. Forty-one percent of respondents reported having ever used Ambien, and 14% reported using it at the time of the survey. Of those who reported a history of Ambien use, 64% considered it to be helpful at improving their sleep-related symptoms (Bennett et al., 2007). An earlier and much smaller-scale survey of 54 fibromyalgia patients found that 10% of respondents had a history of using Ambien, and 80% of those found it very helpful (Wassem et al., 2002).

A double-blind, placebo controlled study conducted in the early 1990s sought to investigate the use of Ambien to improve disturbed sleep, fatigue, pain, and mood in 19 fibromyalgia patients. Following 16 consecutive nights of treatment at one of three Ambien doses (5mg, 10mg, or 15mg), or placebo, the study found that Ambien only resulted in improvements to various measures of sleep, with no improvements in pain, tender points, mood, fatigue, sleepiness, or ability to concentrate. When compared to those who received placebo, those who were treated with Ambien showed significant reductions in the time required to fall asleep, increased duration of sleep, reduced nighttime awakenings, and overall improvement in sleep and daytime energy. It was also determined that the 10mg dose was the most effective while resulting in the fewest side effects (Moldofsky et al., 1996).

Several studies have also investigated the use of Imovane on various symptoms in fibromyalgia patients. Gronblad et al., (1993) used a double-blind, randomized-controlled trial (considered the “gold standard” of research study design) to determine the effect of Imovane on sleep quality, morning stiffness, tenderness, and pain in 33 fibromyalgia patients. Self-reported improvements in sleep quality were reported by over 90% of those patients treated with Imovane after four weeks of treatment, and by approximately 80% after eight weeks: however, similar findings were obtained for those who received placebo, with more than 60% reporting improvements in sleep quality. No other differences between groups were detected with regard to morning stiffness, tenderness, or pain (Gronblad et al., 1993). Similar findings were obtained in an earlier study of 41 fibromyalgia patients, which found that zopiclone may be useful at improving sleep disturbances among fibromyalgia patients, but is not likely useful to improve pain or stiffness (Drewes et al., 1991).

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References

1.        Spaeth M, Rizzi M, Sarzi-Puttini P. Fibromyalgia and sleep. Best Pract Res Clin Rheumatol. 2011;25(2):227-239.

2.        Roizenblatt S, Neto NSR, Tufik S. Sleep disorders and fibromyalgia. Curr Pain Headache Rep. 2011;15:347-357.

3.        Eszopiclone. US National Library of Medicine. PubMed Health.  Last revised: October 1, 2008; Accessed May 14, 2012.

4.        Ramelteon.  US National Library of Medicine. PubMed Health. Last revised: May 1, 2009; Accessed May 14, 2012.

5.        Zaleplon.  US National Library of Medicine. PubMed Health.  Last revised: October 1, 2008; Accessed May 14, 2012.

6.        Zolpidem. US National Library of Medicine. PubMed Health.  Last revised: August 15, 2011; Accessed May 14, 2012.

7.        Product Monograph: Imovane (zopiclone).  Sanofi-Aventis Canada, Inc.  Last revised: October 13, 2011; Accessed May 14, 2012.

8.        Bennett RM, Jones J, Turk DC, Russell IJ, Matallana L. An internet survey of 2,596 people with fibromyalgia. BMC Musculoskelet Disord. 2007; 8:27.

9.        Wassem R, McDonald M, Racine J. Fibromyalgia: patient perspectives on symptoms, symptom management, and provider utilization. Clin Nurse Spec. 2002;16(1):24-28.

10.     Moldofsky H, Lue FA, Mously C, Roth-Schechter B, Reynolds WJ. The effect of zolpidem in patients with fibromyalgia: a dose ranging, double blind, placebo controlled, modified crossover study. J Rheumatol. 1996;23(3):529-33.

11.     Grönblad M, Nykänen J, Konttinen Y, Järvinen E, Helve T. Effect of zopiclone on sleep quality, morning stiffness, widespread tenderness and pain and general discomfort in primary fibromyalgia patients. A double-blind randomized trial. Clin Rheumatol. 1993;12(2):186-191.

Drewes AM, Andreasen A, Jennum P, Nielsen KD. Zopiclone in the treatment of sleep abnormalities in fibromyalgia. Scand J Rheumatol. 1991;20(4):288-293.

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