Pramipexole-induced somnolence and episodes of daytime sleep
Pramipexole is a non‐ergot dopamine agonist used to treat Parkinson's disease (PD). Because of concern regarding driving safety, we evaluated the incidence and nature of somnolence experienced by patients receiving pramipexole in clinical trials at our center. A retrospective chart review was p...
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Published in | Movement disorders Vol. 15; no. 4; pp. 658 - 663 |
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Main Authors | , , , |
Format | Journal Article |
Language | English |
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New York
John Wiley & Sons, Inc
01.07.2000
Wiley |
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Abstract | Pramipexole is a non‐ergot dopamine agonist used to treat Parkinson's disease (PD). Because of concern regarding driving safety, we evaluated the incidence and nature of somnolence experienced by patients receiving pramipexole in clinical trials at our center. A retrospective chart review was performed and structured interviews were conducted with patients who had reported moderate or severe somnolence. In addition, two patients underwent polysomnography (PSG) and multiple sleep latency tests (MSLT) while on and 2 weeks after discontinuation of pramipexole. Forty patients with PD participating in pramipexole clinical trials were identified. In the double‐blind phases of the studies, 22 patients were randomized to pramipexole and 18 were randomized to placebo. Six patients assigned to pramipexole reported somnolence as an adverse event (1 moderate, 5 mild) compared with two patients assigned to placebo (1 severe, 1 moderate; p = 0.19, one‐tailed Fisher's exact test). Thirty‐seven patients participated in open‐label extension studies. Twenty‐one (57%) reported somnolence as an adverse event. Eleven (30%) patients reported moderate somnolence and three (8%) patients reported severe somnolence. For patients with moderate or severe somnolence, the onset of worst‐reported somnolence occurred at a mean (± standard error) pramipexole dose of 4.0 ± 0.4 mg (range, 0.75–4.5 mg) per day. Patients had been taking pramipexole for a total of 10.0 ± 1.5 months (range, .03–22 mos) and at their maximal dose for 6.7 ± 1.5 months (range, .03–20 mos). During structured interviews with 12 of the 14 patients reporting moderate or severe somnolence, seven reported falling asleep while driving and two reported minor motor vehicle accidents caused by falling asleep. Most patients reported relatively continuous drowsiness that led to falling asleep without acute warning during periods of inactivity. Three patients reported discreet waves of irresistible sleepiness heralded by prodromal symptoms occurring against a background of normal wakefulness. MSLT in two of these patients revealed decreased latency to sleep without early onset of rapid eye movements. Sleep latency normalized after withdrawal of pramipexole. Intensive patient education is necessary to prevent motor vehicle accidents in patients taking pramipexole. We recommend that patients who are experiencing generalized drowsiness and falling asleep during periods of inactivity be instructed not to drive because these patients do fall asleep without acute warning. Somnolence usually resolves with pramipexole dose reduction or discontinuation. Patients should also be alerted to pull over and stop driving immediately if they feel a wave of sleepiness coming on. Patient education and compliance are critical to maximize safety. |
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AbstractList | Pramipexole is a non‐ergot dopamine agonist used to treat Parkinson's disease (PD). Because of concern regarding driving safety, we evaluated the incidence and nature of somnolence experienced by patients receiving pramipexole in clinical trials at our center. A retrospective chart review was performed and structured interviews were conducted with patients who had reported moderate or severe somnolence. In addition, two patients underwent polysomnography (PSG) and multiple sleep latency tests (MSLT) while on and 2 weeks after discontinuation of pramipexole. Forty patients with PD participating in pramipexole clinical trials were identified. In the double‐blind phases of the studies, 22 patients were randomized to pramipexole and 18 were randomized to placebo. Six patients assigned to pramipexole reported somnolence as an adverse event (1 moderate, 5 mild) compared with two patients assigned to placebo (1 severe, 1 moderate; p = 0.19, one‐tailed Fisher's exact test). Thirty‐seven patients participated in open‐label extension studies. Twenty‐one (57%) reported somnolence as an adverse event. Eleven (30%) patients reported moderate somnolence and three (8%) patients reported severe somnolence. For patients with moderate or severe somnolence, the onset of worst‐reported somnolence occurred at a mean (± standard error) pramipexole dose of 4.0 ± 0.4 mg (range, 0.75–4.5 mg) per day. Patients had been taking pramipexole for a total of 10.0 ± 1.5 months (range, .03–22 mos) and at their maximal dose for 6.7 ± 1.5 months (range, .03–20 mos). During structured interviews with 12 of the 14 patients reporting moderate or severe somnolence, seven reported falling asleep while driving and two reported minor motor vehicle accidents caused by falling asleep. Most patients reported relatively continuous drowsiness that led to falling asleep without acute warning during periods of inactivity. Three patients reported discreet waves of irresistible sleepiness heralded by prodromal symptoms occurring against a background of normal wakefulness. MSLT in two of these patients revealed decreased latency to sleep without early onset of rapid eye movements. Sleep latency normalized after withdrawal of pramipexole. Intensive patient education is necessary to prevent motor vehicle accidents in patients taking pramipexole. We recommend that patients who are experiencing generalized drowsiness and falling asleep during periods of inactivity be instructed not to drive because these patients do fall asleep without acute warning. Somnolence usually resolves with pramipexole dose reduction or discontinuation. Patients should also be alerted to pull over and stop driving immediately if they feel a wave of sleepiness coming on. Patient education and compliance are critical to maximize safety. Pramipexole is a non-ergot dopamine agonist used to treat Parkinson's disease (PD). Because of concern regarding driving safety, we evaluated the incidence and nature of somnolence experienced by patients receiving pramipexole in clinical trials at our center. A retrospective chart review was performed and structured interviews were conducted with patients who had reported moderate or severe somnolence. In addition, two patients underwent polysomnography (PSG) and multiple sleep latency tests (MSLT) while on and 2 weeks after discontinuation of pramipexole. Forty patients with PD participating in pramipexole clinical trials were identified. In the double-blind phases of the studies, 22 patients were randomized to pramipexole and 18 were randomized to placebo. Six patients assigned to pramipexole reported somnolence as an adverse event (1 moderate, 5 mild) compared with two patients assigned to placebo (1 severe, 1 moderate; p = 0.19, one-tailed Fisher's exact test). Thirty-seven patients participated in open-label extension studies. Twenty-one (57%) reported somnolence as an adverse event. Eleven (30%) patients reported moderate somnolence and three (8%) patients reported severe somnolence. For patients with moderate or severe somnolence, the onset of worst-reported somnolence occurred at a mean (+/- standard error) pramipexole dose of 4.0 +/- 0.4 mg (range, 0.75-4.5 mg) per day. Patients had been taking pramipexole for a total of 10.0 +/- 1.5 months (range, .03-22 mos) and at their maximal dose for 6.7 +/- 1.5 months (range, .03-20 mos). During structured interviews with 12 of the 14 patients reporting moderate or severe somnolence, seven reported falling asleep while driving and two reported minor motor vehicle accidents caused by falling asleep. Most patients reported relatively continuous drowsiness that led to falling asleep without acute warning during periods of inactivity. Three patients reported discreet waves of irresistible sleepiness heralded by prodromal symptoms occurring against a background of normal wakefulness. MSLT in two of these patients revealed decreased latency to sleep without early onset of rapid eye movements. Sleep latency normalized after withdrawal of pramipexole. Intensive patient education is necessary to prevent motor vehicle accidents in patients taking pramipexole. We recommend that patients who are experiencing generalized drowsiness and falling asleep during periods of inactivity be instructed not to drive because these patients do fall asleep without acute warning. Somnolence usually resolves with pramipexole dose reduction or discontinuation. Patients should also be alerted to pull over and stop driving immediately if they feel a wave of sleepiness coming on. Patient education and compliance are critical to maximize safety. |
Author | Anderson, W. McDowell Hauser, Robert A. Gauger, Lisa Zesiewicz, Theresa A. |
Author_xml | – sequence: 1 givenname: Robert A. surname: Hauser fullname: Hauser, Robert A. organization: Department of Neurology, University of South Florida, Tampa General Hospital, Tampa, Florida, U.S.A – sequence: 2 givenname: Lisa surname: Gauger fullname: Gauger, Lisa organization: Department of Neurology, University of South Florida, Tampa General Hospital, Tampa, Florida, U.S.A – sequence: 3 givenname: W. McDowell surname: Anderson fullname: Anderson, W. McDowell organization: Department of Medicine, University of South Florida, Tampa General Hospital, Tampa, Florida, U.S.A – sequence: 4 givenname: Theresa A. surname: Zesiewicz fullname: Zesiewicz, Theresa A. organization: Department of Neurology, University of South Florida, Tampa General Hospital, Tampa, Florida, U.S.A |
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Cites_doi | 10.1001/jama.1997.03550020057038 10.1016/0922-4106(95)90013-6 10.1001/archneur.55.9.1211 10.1097/00002826-199508000-00006 10.1002/mds.870130111 10.1212/WNL.49.4.1060 10.1212/WNL.51.4.1057 10.1212/WNL.49.2.393 10.1212/WNL.52.9.1908 10.1016/0014-2999(92)90024-X 10.1212/WNL.49.3.724 10.1002/mds.870120522 10.1002/mds.870090107 10.1212/WNL.49.1.162 10.1002/mds.870130112 |
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Keywords | Human Nervous system diseases Agonist Vehicle driving Toxicity Parkinson disease Pramipexole Cerebral disorder Somnolence D2 Dopamine receptor Central nervous system disease Degenerative disease Extrapyramidal syndrome |
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References_xml | – volume: 290 start-page: 29 year: 1995 end-page: 36 article-title: Pramipexole binding and activation of cloned and expressed dopamine D2, D3, and D4 receptors publication-title: Eur J Pharmacol – volume: 12 start-page: 845 year: 1997 article-title: Somnolence associated with pramipexole therapy in Parkinson's disease. 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publication-title: Mov Disord – volume: 215 start-page: 161 year: 1992 end-page: 170 article-title: Biochemical and pharmacological studies on pramipexole, a potent and selective dopamine D2 receptor agonist publication-title: Eur J Pharmacol – volume: 49 start-page: 1060 year: 1997 end-page: 1065 article-title: Double‐blind comparison of pramipexole and bromocriptine treatment with placebo in advanced Parkinson's disease publication-title: Neurology – volume: 55 start-page: 1211 year: 1998 end-page: 1216 article-title: Ropinirole for the treatment of early Parkinson's disease publication-title: Arch Neurol – volume: 18 start-page: 338 year: 1995 end-page: 347 article-title: Pramipexole in patients with early Parkinson's disease publication-title: Clin Neuropharmacol – volume: 13 start-page: 39 year: 1998 end-page: 45 article-title: Ropinirole in the treatment of early Parkinson's disease: a 6‐month interim report of a 5‐year levodopa‐controlled study publication-title: Mov Disord – volume: 52 start-page: 1908 year: 1999 end-page: 1910 article-title: Falling asleep at the wheel: motor vehicle mishaps in persons taking pramipexole and ropinirole publication-title: Neurology – volume: 49 start-page: 393 year: 1997 end-page: 399 article-title: Ropinirole for the treatment of early Parkinson's disease publication-title: Neurology – volume: 13 start-page: 46 year: 1998 end-page: 51 article-title: Ropinirole versus bromocriptine in the treatment of early Parkinson's disease: a 6‐month interim report of a 3‐year study publication-title: Mov Disord – volume: 278 start-page: 125 year: 1997 ident: 10.1002/1531-8257(200007)15:4<658::AID-MDS1009>3.0.CO;2-N-BIB5 publication-title: JAMA doi: 10.1001/jama.1997.03550020057038 – volume: 290 start-page: 29 year: 1995 ident: 10.1002/1531-8257(200007)15:4<658::AID-MDS1009>3.0.CO;2-N-BIB2 publication-title: Eur J Pharmacol doi: 10.1016/0922-4106(95)90013-6 contributor: fullname: Mierau – volume: 55 start-page: 1211 year: 1998 ident: 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Snippet | Pramipexole is a non‐ergot dopamine agonist used to treat Parkinson's disease (PD). Because of concern regarding driving safety, we evaluated the incidence and... Pramipexole is a non-ergot dopamine agonist used to treat Parkinson's disease (PD). Because of concern regarding driving safety, we evaluated the incidence and... |
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SubjectTerms | Aged Antiparkinson Agents - adverse effects Antiparkinson Agents - therapeutic use Automobile Driving Benzothiazoles Biological and medical sciences Dose-Response Relationship, Drug Double-Blind Method Driving Drug toxicity and drugs side effects treatment Female Humans Levodopa - adverse effects Levodopa - therapeutic use Male Medical sciences Middle Aged Narcolepsy - chemically induced Narcolepsy - diagnosis Parkinson Disease - drug therapy Parkinson's disease Pharmacology. Drug treatments Polysomnography Pramipexole Retrospective Studies Sleep Somnolence Thiazoles - adverse effects Thiazoles - therapeutic use Toxicity: nervous system and muscle |
Title | Pramipexole-induced somnolence and episodes of daytime sleep |
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