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Butalbital, 5-allyl-5-isobutylbarbituric acid, is a barbiturate with an intermediate duration of action. It has the same chemical formula as talbutal but a different structure. Butalbital is often combined with other medications for the treatment of pain and headache. more...

Benzalkonium chloride

Combinations include:

  • butalbital and acetaminophen (Axocet®, Bucet®, Bupap®, Cephadyn®, Dolgic®, Phrenilin®, Phrenilin Forte®, Sedapap®)
  • butalbital, acetaminophen, and caffeine (Fioricet®, Esgic®, Esgic-Plus®)
  • butalbital and aspirin (Axotal®)
  • butalbital, aspirin, and caffeine (Fiorinal®, Fiormor®, Fiortal®, Fortabs®, Laniroif®)

Side Effects

Side effects for any drug are difficult to predict, but commonly reported side effects for Butalbital include:

  • Dizziness
  • Drowsiness
  • Intoxicated feeling
  • Light-headedness
  • Nausea
  • Sedation
  • Addiction

There are other potential side-effects, this list should not be considered all-inclusive.

Dangers and Risks

Butalbital, is an addictive, mind (and behavior) altering barbituate. Butalbital can be dangerously habit forming. Butalbital should not be mixed with Alcohol due to increased risk of intoxication.

There are other potential risks, this list should not be considered all-inclusive.


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Tension-type headache - Cover article: practical therapeutics
From American Family Physician, 9/1/02 by Paul J. Millea

Tension-type headache, formerly called tension headache or muscle contraction headache, is a common condition usually self-treated with over-the-counter (OTC) analgesics. Prevalence rates of tension-type headaches vary among studies from 29 (1) to 71 (2) percent of patients examined, because of differences in research study design. (3)

Headaches are classified into two categories: primary and secondary. Primary headaches (including migraine, tension-type, and cluster headaches) have no apparent underlying organic disease process. Secondary headaches are caused by an underlying organic disease and are a symptom of a recognized disease process. The International Headache Society's criteria for diagnosing tension-type headache and chronic tension-type headache, (4) and some commonly used criteria for chronic daily headache, (5) are listed in Table 1. (4)

Primary headache is treated symptomatically, with the goal being relief and preventing recurrence. Although secondary headache may also require symptomatic relief, treatment of the underlying disease process is the focus of care.


Although tension-type headaches are common, the pathophysiology and likely mechanism remain unclear. Current knowledge of the nociceptive (pain receptor) system suggests that the derivative pain of tension-type headaches has a muscular origin. Muscular or myofascial pain tends to be dull and achy, poorly localized, and radiating, whereas pain originating from cutaneous structures is sharp, localized, and nonradiating. The supposition that the pain is muscular in origin and related to increased resting muscle tension corresponds with the current clinical understanding of tension-type headache and derived treatment approaches.

Controversy arises because an electromyogram (EMG) often cannot detect increased resting muscle tension in patients diagnosed with tension-type headache. A recent review article (6) noted that the relationship between EMG level and pain is complex enough to warrant further investigation. Muscle hardness (measured by external probing of resting muscle) has been found to be increased in the pericranial muscles of patients with chronic tension-type headache. (7) These findings indicate that muscle hardness was similar during periods with and without headache and that muscle hardness is "permanently altered" in patients with chronic tension-type headache. (7) Further research suggests that nitric oxide may be the local mediator of tension-type headache. Infusion of a nitric oxide donor reproduces tension-type headache in patients previously diagnosed with chronic tension-type headache. (8) [Evidence level B, lower quality randomized controlled trial (RCT)]. Also, blocking nitric oxide production with an investigative agent (L-NMMA) reduces both muscle hardness and pain associated with tension-type headache. (9) [Evidence level B, lower quality RCT]

Evaluation of the Headache Patient


Tension-type headaches can last from 30 minutes to several days and can be continuous in severe cases. The pain is mild or moderately intense and is described as tightness, pressure, or a dull ache. The pain is usually experienced as a band extending bilaterally back from the forehead across the sides of the head to the occiput. (10) Patients often report that this tension radiates from the occiput to the posterior neck muscles. In its most extensive form, the pain distribution is "cape like," radiating along the medial and lateral trapezius muscles covering the shoulders, scapular, and interscapular areas. (10)

In addition to its characteristic distribution and intermittent nature, the history obtained from patients with tension-type headache discloses an absence of signs of any serious underlying condition. (11) Patients with tension-type headache do not typically report any visual disturbance, constant generalized pain, fever, stiff neck, recent trauma, or bruxism. Table 2 (4) lists disease processes that may have headache as a symptom.

A thorough headache history should include questions about the type, amount, effect, and duration of self-treatment strategies. Patients typically self-treat their tension-type headaches with OTC analgesics, caffeinated products, massage or chiropractic therapy for symptom relief. A headache history should also include discussion of any lifestyle changes (e.g., smoking) that may have preceded or exacerbated the headache. (11)

Patients who have chronic daily headache present with the typical pain characteristics of tension-type headache but have symptoms that occur daily or almost daily. A careful history will generally reveal that the daily tension-type headache was preceded by intermittent migraine-type headaches

rather than intermittent tension-type headaches.

The progression of either migraine or tension-type headache into chronic daily headache can occur spontaneously but often occurs in relation to frequent use of analgesic medication. Repeated use of analgesics, especially ones containing caffeine or butalbital, can lead to "rebound" headaches as each dose wears off and patients then take another round of medication. Common features of chronic daily headache associated with frequent analgesic use are early morning awakening with headache, poor appetite, nausea, restlessness, irritability, memory or concentration problems, and depression. (12)

Patients should be screened for psychiatric comorbidity, because anxiety, depression, and psychosocial stress can be prevalent in patients with tension-type headaches. (13)


Clinical signs of headache secondary to hypertension may be similar to tension-type headaches. Although patients often attribute headaches to any degree of hypertension, only severe hypertension (values greater than 200/120 mm Hg) is definitely associated with headache. Headache resolution with blood pressure control confirms the diagnosis. (11)

Physical examination of a patient with headache should include a neurologic evaluation to rule out any serious intracranial pathology. Specifically, cranial nerve defects, cerebellar dysfunction, papilledema or absent venous pulsations on fundal examination, visual field defects, or motor or sensory deficits should be considered. These findings may suggest occult brain tumors, hemorrhage, or increased cerebrospinal fluid pressure.

Temporal mandibular joint dysfunction often complicates headache and should be screened for by palpating the temporal mandibular joints for tenderness and asking the patient about habits such as bruxism and gum chewing. If signs suggestive of secondary headache are present, appropriate diagnostic studies should be done before making a definitive diagnosis of tension-type headache [Reference 15--Evidence level C, expert opinion]. Table 3 (14,15) lists indications for the use of neuroimaging in patients with progressive or continuous headache symptoms. Palpation of the head in patients with tension-type headache may reveal tenderness in the pericranial muscles and tension in the nuchal musculature or trapezius.


Treatment goals for patients with tension-type headache should include recommending effective OTC analgesic agents and discovering and ameliorating any circumstances that may be triggering the headaches or causing the patient concern. Tension-type headache is most commonly self-treated with OTC nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen. A telephone survey (16) found that 98 percent of responders with tension-type headache reported using analgesics. The most common agents used were acetaminophen (56 percent), aspirin (15 percent), or other agents (17 percent). (16)

Research confirms that NSAIDs and acetaminophen are effective in reducing headache symptoms; however, this research offers limited guidance about which one to choose for individual patients. A large, randomized controlled trial (17) assigned patients with tension-type headache to treatment with doses of placebo, 400 mg of ibuprofen, or 1,000 mg of acetaminophen. Both medications were well tolerated and significantly more effective than placebo at relieving the symptoms of headache. Ibuprofen was more effective than acetaminophen. (17) [Evidence level A, RCT]

A similar trial (18) comparing 25 mg of ketoprofen with 1,000 mg of acetaminophen reported that both agents were significantly more effective than placebo at two hours after dosing but no better than placebo in achieving total pain relief at four hours after dosing. This result probably reflects the short duration and self-limiting nature of the episodic tension-type headache. (18) [Evidence level A, RCT]

In patients with chronic tension-type headache, the treatment goals are to initiate effective prophylactic treatment and to manage any residual headaches in a manner that prevents the frequent use of analgesics and the risk for progression to chronic daily headache syndrome.

Patients with chronic tension-type headache should limit their use of analgesics to two times weekly to prevent the development of chronic daily headache. If the patient requires analgesic medication more frequently, adjunctive headache medications can be initiated.

Analgesics can be augmented with a sedating antihistamine, such as promethazine (Phenergan) and diphenhydramine (Benadryl), or an antiemetic, such as metoclopramide (Reglan) and prochlorperazine (Compazine). If this regimen is inadequate, the patient can try acetaminophen or aspirin combined with caffeine and butalbital. This combination is usually quite effective but is also the most frequent cause of chronic daily headache. Before initiating this regimen, patients should be informed of the possibility of chronic daily headache and instructed to limit their use of the combination to twice weekly. The physician should carefully monitor the patient's progress and prescribe only enough medication to support this limited usage.


A wide variety of prophylactic agents have been researched in the management of chronic tension-type headache, and comprehensive reviews are available for interested readers. (19)

Amitriptyline (Elavil) is the most researched of the prophylactic agents for chronic tension-type headache. It is typically used in doses of 10 to 75 mg, one to two hours before bedtime to minimize grogginess on awakening. Double-blind randomized controlled studies confirm its use in patients with chronic tension-type headache. (20) [Evidence level A, RCT] Anticholinergic side effects (dry mouth, blurred vision, orthostasis) and weight gain can limit its usefulness in some persons.

Selective serotonin reuptake inhibitors (SSRIs) cause fewer side effects, and several of these agents (paroxetine [Paxil], venlafaxine [Effexor], and fluoxetine [Prozac]) have shown their efficacy in the prophylaxis of chronic tension-type headache in small studies. (21,22) One small study (23) showed that 20 mg of citalopram (Celexa) had no beneficial effect on tension-type headache, while another small trial (24) noted that amitriptyline and fluoxetine were equally effective in reducing the number of days with headache pain each month. The beneficial effect of fluoxetine only manifested after two months of treatment and was slightly inferior to the effect of amitriptyline. (24)

Smoking cessation is an important issue to address in patients with chronic tension-type headache. The number of cigarettes smoked has been "significantly related" to the headache index score and to the number of days with headache each week. (25) Higher levels of nicotine are also correlated with trends toward higher measures of anger, anxiety, and depression.


The first decision in treating patients who have chronic daily headache is to ascertain how often they are using OTC analgesics. "Rebound" headache is particularly common with use of narcotics and combination products containing butalbital and caffeine. Patients with rebound headache will improve if their daily analgesic medication can be withdrawn, although this is not easily accomplished. (26) The initial task is to assure patients that, although they will experience increased discomfort during the analgesic withdrawal period, their headache frequency and intensity will begin to reduce within two weeks after their withdrawal is complete.

For nonpregnant patients using fewer than seven to 12 tablets or capsules of analgesic daily, the simplest method is to abruptly stop the analgesic and initiate prophylaxis with amitriptyline. Patients will typically experience withdrawal symptoms for several days to weeks. These symptoms include nervousness, restlessness, increased headaches, nausea, vomiting, insomnia, diarrhea, and tremor. (27) Patients who cannot tolerate complete cessation may taper the analgesic dosage over four to six weeks and begin amitriptyline prophylaxis when they have completely stopped taking the analgesic.

In patients using more than 12 tablets or capsules of analgesic daily, particularly those containing butalbital, abrupt cessation is not appropriate because of the possibility of more serious withdrawal symptoms, including seizure or delirium. (28) [Evidence level C, expert opinion] Pregnant patients may be at risk for miscarriage caused by withdrawal symptoms.

A recent approach to discontinuing daily analgesics using a short steroid taper has been reported from a large, open-label trial. (29) [Evidence level B, uncontrolled study] Only patients taking simple analgesics were studied; persons dependent on barbiturates, benzodiazepines, or opiate medications were excluded. Participants immediately ceased all analgesics and began a short course of tapering prednisone (60 mg for two days, 40 mg for two days, and 20 mg for two days), combined with ranitidine (300 mg once daily for six days). Amitriptyline was instituted on the day following the last dose of prednisone. Over 400 patients with chronic daily headache successfully withdrew from their analgesics using this regimen.

After stopping daily analgesic use, patients often revert to the headache pattern that preceded the chronic daily headache (typically, sporadic migraine headache). If this does occur, prophylactic treatment should continue, and migraine-specific treatment should be given for the acute headache. (30)

Nonmedication Therapies for Headache

Although medication is the most commonly used treatment for chronic tension-type headache, a number of other methods have some evidence of efficacy. No large trials with well-designed methodologies have been conducted for most nonmedication therapies; reports of beneficial effects need to be tempered by the high rates of placebo effects for pain treatment.

The most frequently used nonmedication treatments for headache are biofeedback, relaxation training, self-hypnosis, and cognitive therapy. One study (31) showed improvement in 39 percent of 94 patients with headache using relaxation training alone. Adding biofeedback increased the portion of patients experiencing improvement to 56 percent. (31) One small,long-term study (32) of relaxation and EMG biofeedback showed that improvement was maintained at five years' follow-up.

Numerous small studies have investigated cognitive psychotherapy alone and in combination with other behavioral treatment for chronic tension-type headache. Among these trials, at least 50 percent of patients had reduced symptoms when treated with progressive relaxation, cognitive therapy, or a combination of the two. (33) This study (33) compared patients who self-administered treatments at home with patients receiving therapy in the office and noted a trend toward greater symptom reduction in patients receiving in-office treatment; however, this difference was not statistically significant.

A recent systematic review of acupuncture treatment for headache found 40 randomized controlled studies, but only one study was categorized as "rigorous." In all of the trials of tension-type headache that were examined, patients receiving acupuncture had superior outcomes, compared with patients in the control groups. The authors of the review concluded that, "overall, the existing evidence suggests that acupuncture has a role in the treatment of recurrent headaches". (34) [Evidence level A, systematic review of RCTs]

Studies have also been conducted investigating the role of spinal manipulation for headache relief. (35) [Evidence level A, RCTs] In a trial comparing manipulation with the use of amitriptyline, both modalities showed improvement in headache intensity, frequency, and medication usage. However, headache intensity was significantly less in the amitriptyline group. Four weeks after cessation of therapy, patients in the spinal manipulation group continued to experience benefits from the intervention. (35)

The use of traditional physical therapy for headache has been investigated in a randomized controlled trial. (36) [Evidence level B, uncontrolled study] Study participants received weekly sessions of education in proper posture and instruction in a home exercise program, and used ice packs, massage, and "passive mobilization" of the cervical facets. Both headache frequency and psychologic well-being improved significantly in the group receiving physical therapy at the end of six weeks and at the 12-month follow-up. (36)

The authors indicate that they do not have any conflicts of interest. Sources of funding: none reported.


(1.) Gobel H, Petersen-Braun M, Soyka D. The epidemiology of headache in Germany: a nationwide survey of a representative sample on the basis of the headache classification of the International Headache Society. Cephalalgia 1994; 14:97-106.

(2.) Rasmussen BK. Epidemiology of headache. Cephalalgia 1995; 15:45-68.

(3.) Wober-Bingol C, Wober C, Karwautz A, Schnider P, Vesely C, Wagner-Ennsgraber C, et al. Tension-type headache in different age groups at two headache centers. Pain 1996; 67:53-8.

(4.) Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Headache Classification Committee of the International Headache Society. Cephalalgia 1988;8(suppl 7):1-96.

(5.) Solomon S, Lipton RB, Newman LC. Clinical features of chronic daily headache. Headache 1992; 32:325-9.

(6.) Jensen R. Pathophysiological mechanisms of tension-type headache: a review of epidemiological and experimental studies. Cephalalgia 1999; 19:602-21.

(7.) Ashina M, Bendtsen L, Jensen R, Sakai F, Olesen J. Muscle hardness in patients with chronic tension-type headache: relation to actual headache state. Pain 1999; 79:201-5.

(8.) Ashina M, Bendtsen L, Jensen R, Olesen J. Nitric oxide-induced headache in patients with chronic tension-type headache. Brain 2000; 123:1830-7.

(9.) Ashina M, Lassen LH, Bendtsen L, Jensen R, Olesen J. Effect of inhibition of nitric oxide synthase on chronic tension-type headache: a randomised crossover trial. Lancet 1999; 353:287-9.

(10.) Spira PJ. Tension headache. Aust Fam Physician 1998; 27:597-600.

(11.) Marks DR, Rapoport AM. Practical evaluation and diagnosis of headache. Semin Neurol 1997; 17:307-12.

(12.) Rapoport A, Stang P, Gutterman DL, Cady R, Markley H, Weeks R, et al. Analgesic rebound headache in clinical practice: data from a physician survey. Headache 1996; 36:14-9.

(13.) Puca F, Genco S, Prudenzano MP, Savarese M, Bussone G, D'Amico D, et al. Psychiatric comorbidity and psychosocial stress in patients with tension-type headache from headache centers in Italy. The Italian Collaborative Group for the Study of Psychopathological Factors in Primary Headaches. Cephalalgia 1999; 19:159-64.

(14.) Sutton CL, Weisberg LA. Which headache patients should undergo neuroimaging? Emerg Med 1999; 31:12-33.

(15.) Masdeu JC, Drayer BP, Anderson RE, Braffman B, Davis PC, Deck MD, et al. Atraumatic isolated headache--when to image. American College of Radiology. ACR Appropriateness Criteria. Radiology 2000;215(Suppl):487-93.

(16.) Forward SP, McGrath PJ, MacKinnon D, Brown TL, Swann J, Currie EL. Medication patterns of recurrent headache sufferers: a community study. Cephalagia 1998; 18:146-51.

(17.) Schachtel BP, Furey SA, Thoden WR. Nonprescription ibuprofen and acetaminophen in the treatment of tension-type headache. J Clin Pharmacol 1996;36:1120-5.

(18.) Steiner TJ, Lange R. Ketoprofen (25 mg) in the symptomatic treatment of episodic tension-type headache: double-blind placebo-controlled comparison with acetaminophen (1000 mg). Cephalagia 1998:18:38-43.

(19.) Redillas C, Solomon S. Prophylactic pharmacological treatment of chronic daily headache. Headache 2000; 40:83-102.

(20.) Gobel H, Hamouz V, Hansen C, Heininger K, Hirsch S, Lindner V, et al. Chronic tension-type headache: amitriptyline reduces clinical headache-duration and experimental pain sensitivity but does not alter pericranial muscle activity readings. Pain 1994; 59:241-9.

(21.) Langemark M, Olesen J. Sulpiride and paroxetine in the treatment of chronic tension-type headache. An explanatory double-blind trial. Headache 1994; 34:20-4.

(22.) Adelman LC, Adelman JU, Von Seggern R, Mannix LK. Venlafaxine extended release (XR) for the prophylaxis of migraine and tension-type headache: A retrospective study in a clinical setting. Headache 2000; 40:572-80.

(23.) Bendtsen L, Jensen R, Olesen J. A non-selective (amitriptyline), but not a selective (citalopram), serotonin reuptake inhibitor is effective in the prophylactic treatment of chronic tension-type headache. J Neurol Neurosurg Psychiatry 1996; 61:285-90.

(24.) Oguzhanoglu A, Sahiner T, Kurt T, Akalin O. Use of amitriptyline and fluoxetine in prophylaxis of migraine and tension-type headaches. Cephalalgia 1999; 19:531-2.

(25.) Payne TJ, Stetson B, Stevens VM, Johnson CA, Penzien DB, Van Dorsten B. The impact of cigarette smoking on headache activity in headache patients. Headache 1991; 31:329-32.

(26.) Kudrow L. Paradoxical effects of frequent analgesic use. Adv Neurol 1982;33:335-41.

(27.) Mathew NT, Kurman R, Perez F. Drug induced refractory headache-clinical features and management. Headache 1990; 30:634-8.

(28.) McLean W, Boucher EA, Brennan M, Holbrook A, Orser R, Peachey J, et al. Is there an indication for the use of barbiturate-containing analgesic agents in the treatment of pain? Guidelines for their safe use and withdrawal management. Canadian Pharmacists Association. Can J Clin Pharmacol 2000; 7:191-7.

(29.) Krymchantowski AV, Barbosa JS. Prednisone as initial treatment of analgesic-induced daily headache. Cephalalgia 2000; 20:107-13.

(30.) Spierings EL, Ranke AH, Schroevers M, Honkoop PC. Chronic daily headache: a time perspective. Headache 2000; 40:306-10.

(31.) Blanchard EB, et al. Behavioral treatment of 250 chronic headache patients: a clinical replication series. Behavior Therapy 1985; 16:308-27.

(32.) Blanchard EB, Appelbaum KA, Guarnieri P, Morrill B, Dentinger MP. Five year prospective follow-up on the treatment of chronic headache with biofeedback and/or relaxation. Headache 1987; 27:580-3.

(33.) Attanasio V, Andrasik F, Blanchard EB. Cognitive therapy and relaxation training in muscle contraction headache: efficacy and cost-effectiveness. Headache 1987; 27:254-60.

(34.) Melchart D, Linde K, Fischer P, White A, Allais G, Vickers A, et al. Acupuncture for recurrent headaches: a systematic review of randomized controlled trials. Cephalagia 1999; 19:779-86.

(35.) Boline PD, Kassak K, Bronfort G, Nelson C, Anderson AV. Spinal manipulation vs. amitriptyline for the treatment of chronic tension-type headaches: a randomized clinical trial. J Manipulative Physiol Ther 1995;18:148-54.

(36.) Hammill JM, Cook TM, Rosecrance JC. Effectiveness of a physical therapy regimen in the treatment of tension-type headache. Headache 1996; 36:149-53.

Members of various family practice departments develop articles for "Practical Therapeutics." This article is one in a series coordinated by the Department of Family and Community Medicine at the Medical College of Wisconsin, Milwaukee. Guest editors of the series are Linda N. Meurer, M.D., M.P.H., and Douglas Bower, M.D.

PAUL J. MILLEA, M.D., M.S., M.A., is assistant professor of family medicine at the Medical College of Wisconsin, Milwaukee. Dr. Millea received his medical degree from the Medical College of Wisconsin, a master of science in addiction studies from the University of Arizona College of Medicine, Tucson, and a master of arts in bioethics from the Medical College of Wisconsin. He completed a residency in family practice at Baylor College of Medicine, Houston, and a fellowship in family therapy at Galveston Family Institute, Houston.

JONATHAN J. BRODIE, M.D., is in private practice in Milwaukee, Wis. Dr. Brodie received his medical degree from the University of Connecticut School of Medicine, Farmington. He completed a faculty development fellowship at the Medical College of Wisconsin and a family practice residency at Texas Tech University, Lubbock.

Address correspondence to Paul J. Millea, M.D., Department of Family and Community Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd., Milwaukee, WI 53226-0509 (e-mail: Reprints are not available from the authors.

COPYRIGHT 2002 American Academy of Family Physicians
COPYRIGHT 2002 Gale Group

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